A Study of LY3113593 in Participants With Chronic Kidney Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-17

Study Completion Date

2016-06-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

single-blind participant only

Study Groups

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LY3113593

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

Group Type EXPERIMENTAL

LY3113593

Intervention Type DRUG

Administered by slow intravenous (IV) infusion.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by slow intravenous (IV) infusion.

Interventions

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LY3113593

Administered by slow intravenous (IV) infusion.

Intervention Type DRUG

Placebo

Administered by slow intravenous (IV) infusion.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No