A Study of LY3113593 in Participants With Chronic Kidney Disease

Lilly

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: LY3113593

Study type: Interventional

Funder types: Industry

Identifiers

NCT02604160

16045

I7C-MC-FEAC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups, including a placebo group

LY3113593

Experimental group

Description:

Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A.

Treatment:

Drug: LY3113593

Placebo

Placebo Comparator group

Description:

0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A.

Treatment:

Drug: Placebo