A Study of LY3113593 in Participants With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604160
• Other study ID #: 16045
• Secondary ID: I7C-MC-FEAC
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

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

External Links

•   Click here for more information about this study: A Study of LY3113593 in Participants With Chronic Kidney Disease