A Study of LY3113593 in Participants With Chronic Kidney Disease

Phase 1

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: LY3113593; Drug: Placebo

• Registration Number: NCT02604160
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-13
• Study Start: 2015-11-17
• Primary Completion: 2016-06-22
• Study Completion: 2016-06-22
• Results First Submitted: 2017-10-21
• Status Verified: 2018-08
• Results First Submitted QC: 2019-03-19
• Last Update Submitted: 2019-03-19
• Results First Posted: 2019-03-21
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3113593	LY3113593	Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A.
Placebo	Placebo	0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 29	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593	Predose; 0.5, 4 hours post-dose
PK: Area Under the Concentration Versus Time (AUCτ)	Predose; 0.5, 4 hours post-dose	Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W)
Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)	Predose; 0.5, 4 hours post-dose
Number of Participants With Anti-LY3113593 Antibodies Detection	Day 1: Predose; Day 15, 29, 57, 85 and 113	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.

Trial Locations

Locations (5)

Northwest Louisiana Nephrology; 🇺🇸 Shreveport, Louisiana, United States

Clinical Advancement Center, PLLC; 🇺🇸 San Antonio, Texas, 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