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| ID | Type | Description | Link |
|---|---|---|---|
| I5M-MC-FABC | Other Identifier | Eli Lilly and Company |
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This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant discontinues or reduces treatment to stimulate red blood cells. This study will last up to 26 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2928057 (No ESA) | Experimental | Multiple doses of LY2928057 administered intravenously (IV) either once every 2 weeks (Q2W) or once per week (QW) for 6 weeks. Participants discontinued their personal physician-prescribed erythropoiesis stimulating agent (ESA) before treatment. |
|
| LY2928057 (Reduced ESA) | Experimental | Multiple doses of LY2928057 administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment. |
|
| Placebo (No ESA) | Placebo Comparator | Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants discontinued their personal physician-prescribed ESA dose before treatment. |
|
| Placebo (Reduced ESA) | Placebo Comparator | Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2928057 | Drug | Administered intravenously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | Baseline to Study Completion (up to Day 137) |
| Change From Baseline in Hemoglobin at 6 Week Endpoint | Baseline, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Hemoglobin | Baseline through 6 Weeks | |
| Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations Relative to Baseline | Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations relative to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davita Clinical Research, DN | Lakewood | Colorado | 80228 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30677788 | Derived | Sheetz M, Barrington P, Callies S, Berg PH, McColm J, Marbury T, Decker B, Dyas GL, Truhlar SME, Benschop R, Leung D, Berg J, Witcher DR. Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease. Br J Clin Pharmacol. 2019 May;85(5):935-948. doi: 10.1111/bcp.13877. Epub 2019 Mar 4. |
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This study included three parts. Part A was dose escalation (placebo, 300, 600, or 1,000 milligrams [mg] LY2928057). Part B was dose expansion (placebo or 1000 mg LY2928057). Part C was optional, based on predefined pharmacodynamics criteria. Part C was not executed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered intravenously (IV) once every two weeks (Q2W) for six weeks (three doses). |
| FG001 | 300 mg LY2928057 | 300 milligrams (mg) LY2928057 administered IV Q2W for six weeks (three doses). |
| FG002 | 600 mg LY2928057 | 600 mg LY2928057 administered IV Q2W for six weeks (three doses). |
| FG003 | 1000 mg LY2928057 | 1000 mg LY2928057 administered IV Q2W for six weeks (three doses). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Level: Placebo |
| ||||||||||||||||
| Dose Level 300 mg |
| ||||||||||||||||
| Dose Level 600 mg |
| ||||||||||||||||
| Dose Level 1000 mg |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered IV Q2W for six weeks (three doses). |
| BG001 | 300 mg LY2928057 | 300 mg LY2928057 administered IV Q2W for six weeks (three doses). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to Study Completion (up to Day 137) |
|
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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 | Placebo | Placebo administered IV Q2W for six weeks (three doses). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo |
| Drug |
Administered intravenously |
|
| Baseline, 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat) | Baseline through 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr) | Baseline through 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Reticulocyte Count | Baseline through 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count | Baseline through 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV) | Baseline through 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH) | Baseline through 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC) | Baseline through 6 weeks |
| Pharmacodynamics (PD): Maximum Change in Ferritin | Baseline through 6 weeks |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057 | Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2 days (d), 4d, 7d, 9d, 11d postdose; Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose | Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose; |
| Pharmacokinetics: Area Under the Concentration Curve From Time Zero to Infinity (AUC[0-inf]) of LY2928057 | Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose; Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose; | Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose |
| Number of Participants With Anti-LY2928057 Antibodies | Baseline through 84 days |
| Area Under the Plasma Concentration-Time Curve From 0 to 336 Hours AUC(0-336) During and Outside Dialysis | Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose; Dialysis did not occur in cycle 1. | Cycle 1: Predose, end of infusion, 2hours, 4h, 2d, 4d, 7d, 9d, 11d postdose |
| Orlando |
| Florida |
| 32806 |
| United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Davita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Receive at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | 600 mg LY2928057 | 600 mg LY2928057 administered IV Q2W for six weeks (three doses). |
| BG003 | 1000 mg LY2928057 | 1000 mg LY2928057 administered IV Q2W for six weeks (three doses). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 600 mg LY2928057 | 600 mg LY2928057 administered IV Q2W for six weeks (three doses). |
| OG003 | 1000 mg LY2928057 | 1000 mg LY2928057 administered IV Q2W for six weeks (three doses). |
|
|
| Primary | Change From Baseline in Hemoglobin at 6 Week Endpoint | All participants who received three doses of study drug, had pharmacodynamics assessment at Week 6, and/or received anti-anemic rescue therapy per protocol, regardless of whether they completed treatment. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Baseline, Day 42 |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Hemoglobin | All participants who received at least one dose of study drug had evaluable hemoglobin values at baseline and post-baseline. | Posted | Mean | Standard Deviation | millimoles per liter of iron (mml/L-Fe) | Baseline through 6 Weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations Relative to Baseline | Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations relative to baseline. | All participants who received at least one dose of study drug and had evaluable serum Fe values at baseline and post-baseline. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Baseline, 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat) | All participants who received at least one dose of study drug and had evaluable TSat values at baseline and post-baseline. | Posted | Mean | Standard Deviation | percentage change in TSat | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr) | All participants who received at least one dose of study drug had evaluable CHr values at baseline and post-baseline. | Posted | Mean | Standard Deviation | picograms (pg) | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Reticulocyte Count | All participants who received at least one dose of study drug and had evaluable reticulocyte values at baseline and post-baseline. | Posted | Mean | Standard Deviation | gigaparticles per liter (GI/L) | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count | All participants who received at least one dose of study drug and had evaluable RBC values at baseline and post-baseline. | Posted | Mean | Standard Deviation | tera per liter (TI/L) | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV) | All participants who received at least one dose of study drug and had evaluable MCV values at baseline and post-baseline. | Posted | Mean | Standard Deviation | femtoliters (fL) | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH) | All participants who received at least one dose of study drug and had evaluable MCH values at baseline and post-baseline. | Posted | Mean | Standard Deviation | femtomoles of iron (fmol[Fe]) | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC) | All participants who received at least one dose of study drug and had evaluable MCHC values at baseline and post-baseline. | Posted | Mean | Standard Deviation | millimoles/liter of iron (mml/L-Fe) | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Change in Ferritin | All participants who received at least one dose of study drug and had evaluable ferritin values at baseline and post-baseline. | Posted | Mean | Standard Deviation | micrograms/liter (ug/L) | Baseline through 6 weeks |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057 | Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2 days (d), 4d, 7d, 9d, 11d postdose; Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose | All participants who received at least one dose of LY2928057 and had evaluable plasma values. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose; |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Curve From Time Zero to Infinity (AUC[0-inf]) of LY2928057 | Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose; Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose; | All participants who received at least one dose of LY2928057 and had evaluable plasma values. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms x hours/milliliter(µg*h/mL) | Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose |
|
|
|
| Secondary | Number of Participants With Anti-LY2928057 Antibodies | All participants who received at least one dose of study drug and had evaluable antibody values at baseline and post-baseline. | Posted | Number | participants | Baseline through 84 days |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From 0 to 336 Hours AUC(0-336) During and Outside Dialysis | Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose; Dialysis did not occur in cycle 1. | All participants who received 300 mg LY2928057 or 600 mg LY2928057 during dialysis and non-dialysis day and had evaluable plasma values. Data were not collected in the 1000 mg LY2928057 arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 1: Predose, end of infusion, 2hours, 4h, 2d, 4d, 7d, 9d, 11d postdose |
|
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | 300 mg LY2928057 | 300 mg LY2928057 administered IV Q2W for six weeks (three doses). | 2 | 6 | 6 | 6 |
| EG002 | 600 mg LY2928057 | 600 mg LY2928057 administered IV Q2W for six weeks (three doses). | 0 | 11 | 8 | 11 |
| EG003 | 1000 mg LY2928057 | 1000 mg LY2928057 administered IV Q2W for six weeks (three doses). | 1 | 4 | 3 | 4 |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Cycle 2 (Second dose) |
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| Cycle 3 (Third dose) |
|
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| Cycle 2 (Second dose) |
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| Cycle 3 (Third dose) |
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