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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02604160
Other study ID # 16045
Secondary ID I7C-MC-FEAC
Status Completed
Phase Phase 1
First received
Last updated
Start date November 17, 2015
Est. completion date June 22, 2016

Study information

Verified date August 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date June 22, 2016
Est. primary completion date June 22, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
LY3113593
Administered by slow intravenous (IV) infusion.
Placebo
Administered by slow intravenous (IV) infusion.

Locations

Country Name City State
United States Indiana University School of Medicine Indianapolis Indiana
United States DaVita Clinical Research Minneapolis Minnesota
United States Orlando Clinical Research Center Orlando Florida
United States Clinical Advancement Center, PLLC San Antonio Texas
United States Northwest Louisiana Nephrology Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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 non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section. Baseline through Day 29
Secondary Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 Predose; 0.5, 4 hours post-dose
Secondary PK: Area Under the Concentration Versus Time (AUCt) Area under the concentration versus time (AUCt) is the AUC over the dosing interval (Q4W) Predose; 0.5, 4 hours post-dose
Secondary Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb) Predose; 0.5, 4 hours post-dose
Secondary Number of Participants With Anti-LY3113593 Antibodies Detection Participants with a detection of anti-LY3113593 antibodies at baseline and post-baseline time point at the following levels of 1:20, 1:40 or 1:80 titer. Day 1: Predose; Day 15, 29, 57, 85 and 113
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