Phase 1
N=7
A Study of LY3113593 in Participants With Chronic Kidney Disease
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02604160 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
Mar 2019
Primary outcome: 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; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY3113593 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2016
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; 1 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 |
11934; 13567 | — |
| SECONDARY PK: Area Under the Concentration Versus Time (AUCτ) |
2281; 2707 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb) |
— | — |
| SECONDARY Number of Participants With Anti-LY3113593 Antibodies Detection |
1; 0; 1; 0; 1; 0 | — |
Summary
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593.
The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body.
The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.
Eligibility Criteria
Inclusion Criteria
- Receiving hemodialysis regularly (at least 3 times per week) for at least 4 months
- 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 11.0 g/dL at screening
- Have been receiving erythropoiesis stimulating agent (ESA) injections for at least 4 weeks and are willing to stop the injections for approximately 8 weeks
Exclusion Criteria
- Have another health condition that may put the participant at risk or that the study doctor feels would make the participant unsuitable for the study
- Currently taking part in another study
- Have recently (within 30 days) completed a study or have previously taken part in this study
Data sourced from ClinicalTrials.gov (NCT02604160). 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.