Phase 1
Completed N=7
A Study of LY2928057 in Hemodialysis Participants
Renal Insufficiency, Chronic · Kidney Disease, Chronic
Source: ClinicalTrials.gov NCT01991483 ↗
Enrolled (actual)
7
Serious AEs
10.7%
Results posted
Feb 2019
Primary outcomePrimary: 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 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| PRIMARY Change From Baseline in Hemoglobin at 6 Week Endpoint |
-1.674; -1.739; -0.906; -1.623 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Hemoglobin |
1.294; 1.677; 1.162; 1.348 | — |
| SECONDARY Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations Relative to Baseline |
0.99; 1.57; 1.59; 2.36 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat) |
0.2117; 0.5250; 0.5000; 0.4375 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr) |
1.93; 3.00; 3.60; 3.20 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Reticulocyte Count |
49; 72.17; 40.73; 74.25 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count |
0.686; 0.900; 0.627; 0.725 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV) |
5.9; 5.2; 6.2; 7.0 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH) |
0.107; 0.105; 0.091; 0.080 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC) |
1.4; 1.2; 1.6; 1.5 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Change in Ferritin |
269.21; 230.28; 196.46; 146.65 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057 |
67.3; 274; 312; 70.0; 213; 397 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve From Time Zero to Infinity (AUC[0-inf]) of LY2928057 |
1560; 7340; 11200; 1640; 6970; 16100 | — |
| SECONDARY Number of Participants With Anti-LY2928057 Antibodies |
1; 4; 6; 3 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From 0 to 336 Hours AUC(0-336) During and Outside Dialysis |
1550; 7320; 1630; 6940 | — |
Eligibility Criteria
Inclusion Criteria
- Participants having end-stage renal disease (ESRD), have received an erythropoiesis stimulating agent (ESA) at least weekly for 2 weeks prior to screening, and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening (that is, an approximate Kt/V greater than 1.1 (K equals dialyzer clearance of urea, t equals dialysis duration time, V equals volume of distribution of urea, which is approximately equal to the participant's total body water) based on the clinical judgment of participant's nephrologist and investigator and who are willing to stop (Parts A and B) or reduce (Part C) their stable ESA dose from the week of randomization until completion of the 6-week treatment period (unless rescue therapy is needed)
- Have a hemoglobin value (taken prior to dialysis if taken on a dialysis day) greater than or equal to 9.5 grams per deciLiter (g/dL) and less than or equal to 12.5 g/dL at screening
- Have a body mass index (BMI) of 18.5 to 45 kilograms per square meter (kg/m^2) inclusive at screening
- Have a transferrin saturation (TSat) greater than or equality to 15 percent and ferritin greater than 40 nanograms per milliliter (ng/mL) at screening
Exclusion Criteria
- Any cause of anemia other than renal disease
- A history of hyporesponsiveness to ESA
Data sourced from ClinicalTrials.gov (NCT01991483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.