A Study of LY3113593 in Participants With Chronic Kidney Disease



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:November 17, 2015
End Date:June 22, 2016

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

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.


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
We found this trial at
5
sites
825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
Principal Investigator: Jolene Berg
Phone: 612-852-7024
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
Principal Investigator: Thomas Marbury
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Brian Decker
Phone: 317-944-8660
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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San Antonio, Texas 78215
Principal Investigator: P E Pergola, MD
Phone: 210-223-4444
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Shreveport, Louisiana 71101
Principal Investigator: S B Alla, MD
Phone: 318-227-8899
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Shreveport, LA
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