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Completed

NCT Number: NCT02604160

A Study of LY3113593 in Participants With Chronic Kidney Disease

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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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3113593

Drug

Administered by slow intravenous (IV) infusion.

Placebo

Drug

Administered by slow intravenous (IV) infusion.

Primary outcomes

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: 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 outcomes

  1. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593

    Time frame: Predose; 0.5, 4 hours post-dose

  2. PK: Area Under the Concentration Versus Time (AUCτ)

    Time frame: Predose; 0.5, 4 hours post-dose

    Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W)

  3. Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)

    Time frame: Predose; 0.5, 4 hours post-dose

  4. Number of Participants With Anti-LY3113593 Antibodies Detection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2015
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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