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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005621-28 |
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This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mircera in Renal Anemia | Experimental | Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Drug | Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. | Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Time-Adjusted Hb From Baseline to EEP | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baja | 6500 | Hungary | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26965694 | Derived | Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera in Renal Anemia | Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat (ITT) Population: All participants who received at least one dose of Mircera/CERA and for whom data from at least one follow-up assessment were available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera in Renal Anemia | Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. | Per Protocol (PP) Population: All participants from the ITT Population who fulfill inclusion/exclusion criteria per study protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
|
Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population: All participants who received at least one dose of trial medication and at least one safety follow-up assessment, whether prematurely withdrawn or not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mircera in Renal Anemia | Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolysis | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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|
| At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP | During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds. | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Mean Time Spent in the Target Range for Hb During the EEP | During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days. | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP | Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP | Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Number of Participants Receiving Blood Transfusion During the DTP and EEP | The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported. | Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 |
| Number of Blood Transfusions During the DTP and EEP | The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported. | Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 |
| Budapest |
| 1062 |
| Hungary |
| Debrecen | 4032 | Hungary |
| Esztergom | 2500 | Hungary |
| Keszthely | 8360 | Hungary |
| Miskolc | 3526 | Hungary |
| Salgótarján | 3100 | Hungary |
| Szolnok | 5000 | Hungary |
| Vác | 2600 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Renal Transplantation |
|
| Withdrawal by Subject |
|
| Missed Pregnancy Test |
|
| Other Screening Failure |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Mircera in Renal Anemia | Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL. |
|
|
| Secondary | Mean Change in Time-Adjusted Hb From Baseline to EEP | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL. | ITT Population. | Posted | Mean | Standard Deviation | g/dL | At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
|
|
|
| Secondary | Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP | During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
|
|
|
| Secondary | Mean Time Spent in the Target Range for Hb During the EEP | During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days. | ITT Population. | Posted | Mean | Standard Deviation | days | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
|
|
|
| Secondary | Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP | Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg. | ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis. | Posted | Mean | Standard Deviation | mcg | Weeks 0, 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP | Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP. | ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis. | Posted | Number | percentage of participants | Weeks 0, 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Number of Participants Receiving Blood Transfusion During the DTP and EEP | The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported. | ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis. | Posted | Number | participants | Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 |
|
|
|
| Secondary | Number of Blood Transfusions During the DTP and EEP | The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported. | ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis. | Posted | Number | blood transfusions | Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 |
|
|
|
| 45 |
| 114 |
| 40 |
| 114 |
| Cardiac asthma | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Medical device complication | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Renal cyst infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Shunt thrombosis | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (13.1) | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.