A Phase 1 interventional study of LY2928057 and Placebo in Renal Insufficiency, Chronic and Kidney Disease, Chronic, sponsored by Eli Lilly and Company. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 28 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: LY2928057
Multiple doses of LY2928057 administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment.
Drug: LY2928057
Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants discontinued their personal physician-prescribed ESA dose before treatment.
Drug: Placebo
Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment.
Drug: Placebo
Administered intravenously
Administered intravenously
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.
Time frame: Baseline to Study Completion (up to Day 137)
Change From Baseline in Hemoglobin at 6 Week Endpoint
Time frame: Baseline, Day 42
Pharmacodynamics (PD): Maximum Change in Hemoglobin
Time frame: 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.
Time frame: Baseline, 6 weeks
Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat)
Time frame: Baseline through 6 weeks
Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr)
Time frame: Baseline through 6 weeks
Pharmacodynamics (PD): Maximum Change in Reticulocyte Count
Time frame: Baseline through 6 weeks
Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count
Time frame: Baseline through 6 weeks
Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV)
Time frame: Baseline through 6 weeks
Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH)
Time frame: Baseline through 6 weeks
Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC)
Time frame: Baseline through 6 weeks
Pharmacodynamics (PD): Maximum Change in Ferritin
Time frame: 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
Time frame: 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;
Time frame: Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose
Number of Participants With Anti-LY2928057 Antibodies
Time frame: 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.
Time frame: Cycle 1: Predose, end of infusion, 2hours, 4h, 2d, 4d, 7d, 9d, 11d postdose
| Milestone | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Started | 7 | 0 | 0 | 0 |
| Received at least one dose of study drug | 7 | 0 | 0 | 0 |
| Completed | 7 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Started | 0 | 6 | 0 | 0 |
| Received at least one dose of study drug | 0 | 6 | 0 | 0 |
| Completed | 0 | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Started | 0 | 0 | 11 | 0 |
| Receive at least one dose of study drug | 0 | 0 | 11 | 0 |
| Completed | 0 | 0 | 9 | 0 |
| Not completed | 0 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 |
| Milestone | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 4 |
| Received at least one dose of study drug | 0 | 0 | 0 | 4 |
| Completed | 0 | 0 | 0 | 3 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 |
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
| Participants | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 | 0 | 0 | 0 |
| grams per deciliter (g/dL) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Change From Baseline in Hemoglobin at 6 Week Endpoint | -1.674 ± 0.5535 | -1.739 ± 0.5261 | -0.906 ± 0.4577 | -1.623 ± 1.0469 |
| millimoles per liter of iron (mml/L-Fe) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Hemoglobin | 1.294 ± 0.320 | 1.677 ± 0.701 | 1.162 ± 0.367 | 1.348 ± 0.563 |
Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations relative to baseline.
| Ratio | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations Relative to Baseline | 0.99 ± 16 | 1.57 ± 32 | 1.59 ± 69 | 2.36 ± 44 |
| percentage change in TSat | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat) | 0.2117 ± 0.1120 | 0.5250 ± 0.0873 | 0.5000 ± 0.1550 | 0.4375 ± 0.0624 |
| picograms (pg) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr) | 1.93 ± 0.45 | 3.00 ± 1.18 | 3.60 ± 2.31 | 3.20 ± 1.45 |
| gigaparticles per liter (GI/L) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Reticulocyte Count | 49 ± 37.6 | 72.17 ± 29.21 | 40.73 ± 13.81 | 74.25 ± 78.73 |
| tera per liter (TI/L) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count | 0.686 ± 0.135 | 0.900 ± 0.341 | 0.627 ± 0.228 | 0.725 ± 0.299 |
| femtoliters (fL) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV) | 5.9 ± 4.6 | 5.2 ± 1.9 | 6.2 ± 1.7 | 7.0 ± 3.2 |
| femtomoles of iron (fmol[Fe]) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH) | 0.107 ± 0.029 | 0.105 ± 0.027 | 0.091 ± 0.050 | 0.080 ± 0.034 |
| millimoles/liter of iron (mml/L-Fe) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC) | 1.4 ± 0.5 | 1.2 ± 0.4 | 1.6 ± 0.7 | 1.5 ± 0.6 |
| micrograms/liter (ug/L) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Pharmacodynamics (PD): Maximum Change in Ferritin | 269.21 ± 112.17 | 230.28 ± 80.08 | 196.46 ± 90.90 | 146.65 ± 48.05 |
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
| micrograms per milliliter (µg/mL) | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|
| Cycle 1 (First dose) | 67.3 ± 25 | 274 ± 104 | 312 ± 21 |
| Cycle 2 (Second dose) | 70.0 ± 21 | 213 ± 49 | 397 ± 30 |
| Cycle 3 (Third dose) | 62.8 ± 21 | 177 ± 34 | 358 ± NA |
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;
| micrograms x hours/milliliter(µg*h/mL) | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|
| Cycle 1 (First dose) | 1560 ± 39 | 7340 ± 33 | 11200 ± 24 |
| Cycle 2 (Second dose) | 1640 ± 42 | 6970 ± 40 | 16100 ± 31 |
| Cycle 3 (Third dose) | 1520 ± 40 | 6520 ± 25 | 12000 ± NA |
| participants | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| Number of Participants With Anti-LY2928057 Antibodies | 1 | 4 | 6 | 3 |
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.
| hr*ng/mL | 300 mg LY2928057 | 600 mg LY2928057 |
|---|---|---|
| Cycle 1 (First dose, no dialysis) | 1550 ± 39 | 7320 ± 33 |
| Cycle 2 (Second dose during dialysis) | 1630 ± 42 | 6940 ± 40 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/7 (0%) | 7/7 (100%) |
| 300 mg LY2928057 | — | 2/6 (33.3%) | 6/6 (100%) |
| 600 mg LY2928057 | — | 0/11 (0%) | 8/11 (72.7%) |
| 1000 mg LY2928057 | — | 1/4 (25%) | 3/4 (75%) |
| Event | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/7 | 2/6 | 0/11 | 0/4 |
| HypertensionVascular disorders | 0/7 | 2/6 | 0/11 | 0/4 |
| PneumoniaInfections and infestations | 0/7 | 0/6 | 0/11 | 1/4 |
| SyncopeNervous system disorders | 0/7 | 1/6 | 0/11 | 1/4 |
| Staphylococcal bacteraemiaInfections and infestations | 0/7 | 1/6 | 0/11 | 0/4 |
| Ankle fractureInjury, poisoning and procedural complications | 0/7 | 1/6 | 0/11 | 0/4 |
| FallInjury, poisoning and procedural complications | 0/7 | 1/6 | 0/11 | 0/4 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/7 | 1/6 | 0/11 | 0/4 |
| Event | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 5/7 | 2/6 | 3/11 | 2/4 |
| FatigueGeneral disorders | 1/7 | 2/6 | 0/11 | 0/4 |
| ConstipationGastrointestinal disorders | 0/7 | 0/6 | 1/11 | 1/4 |
| Chest painGeneral disorders | 0/7 | 0/6 | 0/11 | 1/4 |
| InsomniaPsychiatric disorders | 0/7 | 0/6 | 0/11 | 1/4 |
| DizzinessNervous system disorders | 0/7 | 1/6 | 2/11 | 0/4 |
| ToothacheGastrointestinal disorders | 0/7 | 1/6 | 0/11 | 0/4 |
| BronchitisInfections and infestations | 0/7 | 1/6 | 0/11 | 0/4 |
| PharyngitisInfections and infestations | 0/7 | 1/6 | 0/11 | 0/4 |
| ContusionInjury, poisoning and procedural complications | 0/7 | 1/6 | 0/11 | 0/4 |
All participants who received at least one dose of study drug.
| Age, Continuous(years) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 | Total |
|---|---|---|---|---|---|
| Mean | 52.1 ± 9.1 | 52.5 ± 4.1 | 52.5 ± 7.6 | 61.0 ± 9.8 | 53.6 ± 8.0 |
| Sex: Female, Male(Participants) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 | Total |
|---|---|---|---|---|---|
| Female | 2 | 2 | 3 | 2 | 9 |
| Male | 5 | 4 | 8 | 2 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 0 | 3 |
| Not Hispanic or Latino | 6 | 6 | 9 | 4 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 7 | 3 | 19 |
| White | 3 | 1 | 4 | 1 | 9 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | 300 mg LY2928057 | 600 mg LY2928057 | 1000 mg LY2928057 | Total |
|---|---|---|---|---|---|
| United States | 7 | 6 | 11 | 4 | 28 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →