| Primary | Characterization of Maximum Tolerated Dose (MTD) | The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows:
- Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline
- Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia.
- ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase)
- ≥ Grade 4 hematologic toxicity
- ≥ Grade 3 non-hematologic toxicity
| The MTD analysis population included all participants in the safety analysis population, which included all participants randomized and treated with any amount of study medication with exception of those replaced due to a non-safety reason. | Posted | | Number | | Events | | Weeks 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on Erythropoiesis stimulating agents (ESA) and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG003 | COR-001 20 mg | Participants received 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
| | Units | Counts |
|---|
| Participants | - OG00012
- OG00116
- OG00216
- OG003
|
| | Title | Denominators | Categories |
|---|
| Infection SAEs with confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. | | |
| |
| Primary | Change in High-sensitivity C-reactive Protein (hsCRP): Week 4 | Change from the baseline in hsCRP values to week 4 are presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Milligrams per liter (mg/L) | | From baseline (mean of screening and day 1) to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Primary | Change in Serum Amyloid A (SAA): Week 4 | Change from the baseline in serum amyloid A (SAA) values to week 4 are presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/L | | From baseline (mean of screening and day 1) to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Number of Adverse Events of Special Interest | Frequency of events of interest by treatment group and dose from baseline until the end of the safety follow-up period (week 24) were reported. Adverse events of special interest included severe infusion-related reactions, hypersensitivity reaction during study drug infusion, anaphylaxis and neutropenia events of grade 2 or higher (i.e., absolute neutrophil count <1500/mm^3 and decline by at least 25% from baseline). | The safety analysis population included all participants randomized and treated with any amount of study medication. | Posted | | Number | | Events | | Weeks 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg |
|
| Secondary | Number of Treatment Emergent Adverse Events (TEAEs) | An AE (adverse event) is any undesirable event or any untoward medical occurrence that occurs to a participant during the course of a study, or the protocol-defined time after study termination, whether or not that event is considered Study Drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of study. Number of TEAEs from baseline until the end of safety follow up (week 24) were presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. | Posted | | Number | | Events | | Week 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 |
|
| Secondary | Electrocardiogram (ECG) | A summary of the overall ECG interpretation and clinical significance from baseline until the end of the safety follow up period (week 24) is presented and categorized as Normal, Abnormal clinically significant (CS), Abnormal non clinically significant (NCS) and Missing. | The safety analysis population included all participants randomized and treated with any amount of study medication. | Posted | | Count of Participants | | Participants | | At baseline, week 6, week 12, week 18 and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Number of Participants Who Developed Anti-drug Antibodies (ADAs) | Number of participants who developed ADAs from baseline until the end of the extended follow up period (week 35) were reported. Samples with detectable ADAs were classified as positive for ADAs. Samples without detectable ADAs were classified as negative for ADAs. | The PK population included all participants who had any valid samples measured for study drug levels. | Posted | | Count of Participants | | Participants | | Weeks 0-35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Number of Participants With ADA Titers | Number of participants with ADA titers for ADA-positive samples from baseline to week 35 is presented. | The PK population included all participants who had any valid samples measured for study drug levels. | Posted | | Count of Participants | | Participants | | Weeks 0-35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Number of Participants With Neutralizing ADAs | Number of participants with neutralizing ADAs from baseline to week 35 are presented. | The PK population included all participants who had any valid samples measured for study drug levels. | Posted | | Count of Participants | | Participants | | From baseline (mean of screening and week 1) to week 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Transferrin Saturation (TSAT): Week 4 | Change from baseline in TSAT to week 4 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of TSAT | | From baseline (mean of screening and day 1) to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in TSAT: Mean of Weeks 10-12 | Change from baseline in TSAT to the mean of weeks 10-12 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of TSAT | | From baseline (mean of screening and day 1), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Reticulocyte Hemoglobin (CHr): Week 4 | Change from baseline in CHr to week 4 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Picograms (pg) | | From baseline (mean of screening and day 1) to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks | Change from baseline in hs-CRP to the mean of 10-12 weeks is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/L | | From baseline (mean of screening and day 1), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in SAA: Mean of Weeks 10-12 | Change from baseline in SAA to the mean of weeks 10-12 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/L | | From baseline (mean of screening and day 1), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Serum Pre-albumin: Mean of 10-12 Weeks | Change from baseline in serum pre-albumin to the mean of 10-12 weeks is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Milligrams per decilitre (mg/dL) | | From baseline (mean of screening and day 1), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Albumin: Week 12 | Change from baseline in albumin to week 12 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Grams per decilitre (g/dL) | | From baseline (mean of screening and day 1) to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Erythropoietin Resistance Index (ERI): Week 4 | Change from baseline in ERI to week 4 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | (Unit/kg/week) per (g/dL) | | From baseline (weekly mean of screening) to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg |
|
| Secondary | Change in ERI: Mean of Weeks 8-12 | Change from baseline in ERI to the mean of weeks 8-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | (Units/kg/week) per (g/dL) | | From baseline (weekly mean of screening), week 8, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg |
|
| Secondary | Change in ERI: Mean of Weeks 10-12 | Change from baseline in ERI to the mean of weeks 10-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | (Units/kg/week) per (g/dL) | | From baseline (weekly mean of screening), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg |
|
| Secondary | Change in CHr: Mean of Weeks 10-12 | Change from baseline in CHr to the mean of weeks 10-12 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | pg | | From baseline (mean of screening and day 1), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Hemoglobin: Week 4 | Change from baseline in hemoglobin to week 4 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | From baseline (mean of screening and day 1) to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Hemoglobin: Mean of Weeks 10-12 | Change from baseline in hemoglobin to weeks 10-12 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | From baseline (mean of screening and day 1), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose | Change from baseline in hemoglobin to weeks 10-12, excluding hemoglobin values following a change in the total weekly ESA (erythropoiesis stimulating agent) dose is presented. A change is defined as the first time when the ESA weekly dose goes up by >25% or down by >25% relative to the previous week's dose. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | From baseline (mean of screening and day 1), week 10, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in ERI: Week 12 | Change from baseline in ERI to week 12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | (Units/kg/week) per (g/dL) | | From baseline (weekly mean of screening) to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | |
|
| Secondary | Change in ERI: Mean of Weeks 9-12 | Change from baseline in ERI to the mean of weeks 9-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL). | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | (Units/kg/week) per (g/dL) | | From baseline (weekly mean of screening), week 9, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg |
|
| Secondary | Change in Hemoglobin: Week 12 | Change from baseline in hemoglobin to week 12 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | From baseline (mean of screening and day 1) to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Hemoglobin: Week 24 | Change from baseline in hemoglobin to week 24 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | From baseline (mean of screening and day 1) to week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4 | Change in hemoglobin from screening to peak hemoglobin at week 4 is presented. | The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | From screening to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Basophils: Week 12 | The observed values of basophils at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells per microliter(10^3 cells/uL) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Basophil: Week 24 | The observed values of basophils at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Basophils to Leukocytes Ratio: Week 12 | Basophils to leukocytes ratio at week 12 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of basophils to leukocytes | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Basophils to Leukocytes Ratio: Week 24 | Basophils to leukocytes ratio at week 24 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of basophils to leukocytes | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Eosinophils: Week 12 | The observed values of eosinophils at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Eosinophils: Week 24 | The observed values of eosinophils at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Eosinophils to Leukocytes Ratio: Week 12 | Eosinophils to leukocytes ratio at week 12 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of eosinophils to leukocytes | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Eosinophils to Leukocytes Ratio: Week 24 | The eosinophils to leukocytes ratio at week 24 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of eosinophils to leukocytes | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocyte Mean Corpuscular Hemoglobin: Week 12 | The observed values of erythrocyte mean corpuscular hemoglobin at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | pg | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocyte Mean Corpuscular Hemoglobin: Week 24 | The observed values of erythrocyte mean corpuscular hemoglobin at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | pg | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12 | The observed values of erythrocyte mean corpuscular HGB concentration at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Grams per deciliter (g/dL) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocyte Mean Corpuscular HGB Concentration: Week 24 | The observed values of erythrocyte mean corpuscular HGB concentration at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocyte Mean Corpuscular Volume: Week 12 | The observed values of erythrocyte mean corpuscular volume at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | femtoliters (fL) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocyte Mean Corpuscular Volume: Week 24 | The observed values of erythrocyte mean corpuscular volume at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | fL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocytes: Week 12 | The observed values of erythrocytes at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^6 cells per microliter(10^6 cells/uL) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Erythrocytes: Week 24 | The observed values of erythrocytes at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^6 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hematocrit: Week 12 | The observed values of hematocrit at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of Hematocrit | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hematocrit: Week 24 | The observed values of hematocrit at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of Hematocrit | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hemoglobin: Week 12 | The observed values of hemoglobin at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hemoglobin: Week 24 | The observed values of hemoglobin at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hypochromatic Red Cells Week 12 | The observed values of hypochromatic red cells at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of Hypochromatic red cells | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hypochromatic Red Cells: Week 24 | The observed values of hypochromatic red cells at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of Hypochromatic red cells | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Leukocytes: Week 12 | The observed values of leukocytes at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Leukocytes: Week 24 | The observed values of leukocytes at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Lymphocytes: Week 12 | The observed values of lymphocytes at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Lymphocytes: Week 24 | The observed values of lymphocytes at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Lymphocytes to Leukocytes Ratio: Week 12 | Lymphocytes to leukocytes ratio at week 12 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of lymphocytes to leukocytes | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Lymphocytes to Leukocytes Ratio at Week 24 | Lymphocytes to leukocytes ratio at week 24 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of lymphocytes to leukocytes | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Monocytes: Week 12 | The observed values of monocytes at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Monocytes: Week 24 | The observed values of monocytes at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Monocytes to Leukocytes Ratio: Week 12 | Monocytes to leukocytes ratio at week 12 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of monocytes to leukocytes | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Monocytes to Leukocytes Ratio: Week 24 | Monocytes to leukocytes ratio at week 24 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of monocytes to leukocytes | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Neutrophils: Week 12 | The observed values of neutrophils at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Neutrophils: Week 24 | The observed values of neutrophils at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Neutrophils to Leukocytes Ratio: Week 12 | Neutrophils to leukocytes ratio at week 12 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of neutrophils to leukocytes | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Neutrophils to Leukocytes Ratio: Week 24 | Neutrophils to leukocytes ratio at week 24 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of neutrophils to leukocytes | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Platelets: Week 12 | The observed values of platelets at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Platelets: Week 24 | The observed values of platelets at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Reticulocytes to Erythrocytes Ratio: Week 12 | Reticulocytes to erythrocytes ratio at week 12 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of reticulocytes to erythrocytes | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Reticulocytes to Erythrocytes Ratio: Week 24 | Reticulocytes to erythrocytes ratio at week 24 is presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Ratio of reticulocytes to erythrocytes | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Alanine Aminotransferase: Week 12 | The observed values of alanine aminotransferase at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | units per liter (U/L) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Alanine Aminotransferase: Week 24 | The observed values of alanine aminotransferase at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Albumin: Week 12 | The observed values of albumin at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Albumin: Week 24 | The observed values of albumin at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Alkaline Phosphatase: Week 12 | The observed values of alkaline phosphatase at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Alkaline Phosphatase: Week 24 | The observed values of alkaline phosphatase at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Aspartate Aminotransferase: Week 12 | The observed values of aspartate aminotransferase at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Aspartate Aminotransferase: Week 24 | The observed values of aspartate aminotransferase at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Bicarbonate: Week 12 | The observed values of bicarbonate at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | millimoles per liter (mmol/L) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Bicarbonate: Week 24 | The observed values of bicarbonate at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Bilirubin: Week 12 | The observed values of bilirubin at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Bilirubin: Week 24 | The observed values of bilirubin at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Calcium: Week 12 | The observed values of calcium at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Calcium: Week 24 | The observed values of calcium at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Chloride: Week 12 | The observed values of chloride at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Chloride: Week 24 | The observed values of chloride at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Cholesterol: Week 12 | The observed values of cholesterol at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Cholesterol: Week 24 | The observed values of cholesterol at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Creatinine: Week 12 | The observed values of creatinine at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Creatinine: Week 24 | The observed values of creatinine at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Direct Bilirubin: Week 12 | The observed values of direct bilirubin at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Direct Bilirubin: Week 24 | The observed values of direct bilirubin at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Glucose: Week 12 | The observed values of glucose at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Glucose: Week 24 | The observed values of glucose at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | High-density Lipoprotein (HDL) Cholesterol: Week 12 | The observed values of HDL cholesterol at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | HDL Cholesterol: Week 24 | The observed values of HDL cholesterol at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hepcidin-25: Week 12 | The observed values of hepcidin-25 at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Hepcidin-25: Week 24 | The observed values of hepcidin-25 at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | ng/mL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Low-density Lipoproteins (LDL) Cholesterol: Week 12 | The observed values of LDL cholesterol at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | LDL Cholesterol: Week 24 | The observed values of LDL cholesterol at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Lipoprotein-a: Week 12 | The observed values of lipoprotein-a at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Nanomoles per litre (nmol/L) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Lipoprotein-a: Week 24 | The observed values of lipoprotein-a at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | nmol/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Phosphate: Week 12 | The observed values of phosphate at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Phosphate: Week 24 | The observed values of phosphate at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Potassium: Week 12 | The observed values of potassium at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Potassium: Week 24 | The observed values of potassium at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Sodium: Week 12 | The observed values of sodium at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Sodium: Week 24 | The observed values of sodium at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Triglycerides: Week 12 | The observed values of triglyceride at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Triglycerides: Week 24 | The observed values of triglycerides at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Urea Nitrogen: Week 12 | The observed values of urea nitrogen at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Urea Nitrogen: Week 24 | The observed values of urea nitrogen at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/dL | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Body Mass Index (BMI): Week 12 | Pre-dialysis BMI values at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | kilogram per meter^2 (kg/m^2) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-infusion BMI: Week 11 | Pre-infusion BMI values at week 11 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Kg/m^2 | | At week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Diastolic Blood Pressure: Week 12 | Pre-dialysis diastolic blood pressure values at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Millimetre of mercury (mm Hg) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Diastolic Blood Pressure: Week 24 | Pre-dialysis diastolic blood pressure values at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-infusion Diastolic Blood Pressure: Week 11 | Pre-infusion diastolic blood pressure values at week 11 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | At week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Heart Rate: Week 12 | Pre-dialysis heart rate values at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | beats/min | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Heart Rate: Week 24 | Pre-dialysis heart rate values at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | beats/min | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-infusion Heart Rate: Week 11 | Pre-infusion heart rate values at week 11 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | beats/min | | At week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Respiration Rate: Week 12 | Pre-dialysis respiration rate values at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | breaths per minute (breaths/min) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Respiration Rate: Week 24 | Pre-dialysis respiration rate values at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | breaths/min | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-infusion Respiration Rate: Week 11 | Pre-infusion respiration rate values at week 11 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | breaths/min | | At week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Systolic Blood Pressure: Week 12 | Pre-dialysis values of systolic blood pressure at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Systolic Blood Pressure: Week 24 | Pre-dialysis values of systolic blood pressure at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | At week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-infusion Systolic Blood Pressure: Week 11 | Pre-infusion systolic blood pressure values at week 11 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | At week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Weight: Week 12 | Pre-dialysis weight values at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Kilogram (Kg) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-infusion Weight: Week 11 | Pre-infusion weight values at week 11 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Kg | | At week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
|
| Secondary | Pre-dialysis Temperature: Week 12 | Pre-dialysis temperature values at week 12 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Celsius (C) | | At week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
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| Secondary | Pre-dialysis Temperature: Week 24 | Pre-dialysis temperature values at week 24 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | C | | At week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
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| Secondary | Pre-infusion Temperature: Week 11 | Pre-infusion temperature values at week 11 are presented. | The safety analysis population included all participants randomized and treated with any amount of study medication. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | C | | At week 11 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo matched to Ziltivekimab once every 14 days for 12 weeks treatment period. Participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
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| Secondary | Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001 | Area under the serum concentration time curve from time 0 to infinity (AUC 0-α) of COR-001 is presented. | The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | nanogram*day/milliliter (ng*day/mL) | | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | | | | ID | Title | Description |
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| OG000 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. |
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| Secondary | Elimination Half-life in the Initial Phase (t 1/2,α) | Elimination half-life in the initial phase (t 1/2,α) is presented from week 0 to week 35. | The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Days | | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | | | | ID | Title | Description |
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| OG000 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 |
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| Secondary | Elimination Half-life in the Terminal Phase (t 1/2, z) | Elimination half-life in the terminal phase(t 1/2, z) is presented from week 0 to week 35. | The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Days | | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | | | | ID | Title | Description |
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| OG000 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 |
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| Secondary | Maximum Serum Concentration (Cmax) | Maximum serum concentration (Cmax) of COR-001 from week 0 to week 35 is presented. | The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | ng/mL | | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | | | | ID | Title | Description |
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| OG000 | COR-001 2 mg | Participants received 2 mg ziltivekimab via Intravenous (IV) infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG001 | COR-001 6 mg | Participants received 6 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients. | | OG002 | COR-001 20 mg |
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| Secondary | Impact of ADAs on Pharmacokinetics | Presence of ADA was a covariate for pharmacokinetics (PK) affecting V1 (volume of distribution for the central compartment). Impact of ADAs on V1 from baseline to week 35 is presented. In the below table, result presented is the bootstrap parameter estimate of the effect of ADA on V1 for a PK model that includes data for all arms combined. | The PK population included all participants who had any valid samples measured for study drug levels. Overall number of participants analysed = number of participants with available data. | Posted | | Mean | 95% Confidence Interval | Milliliter (mL) | | Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239). | | | | ID | Title | Description |
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| OG000 | COR-001 | Participants were randomized to ziltivekimab (COR-001) or placebo within each cohort. Participants received 2 mg or 6 mg or 20 mg ziltivekimab via IV infusion once every 14 days over approximately 60 minutes, which started any time prior to the last 1 hour of dialysis for 12 weeks treatment period. Randomized participants were continued on ESA and parenteral iron, if being given. All the participants were hemodialysis patients |
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