A Study of LY3113593 in Participants With Chronic Kidney Disease

NCT02604160 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16045I7C-MC-FEAC
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Kidney Disease

Outcome Measures

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

  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 Outcomes (4)

• Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593

  Predose; 0.5, 4 hours post-dose

• PK: Area Under the Concentration Versus Time (AUCτ)

  Predose; 0.5, 4 hours post-dose

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

  Predose; 0.5, 4 hours post-dose

• Number of Participants With Anti-LY3113593 Antibodies Detection

  Day 1: Predose; Day 15, 29, 57, 85 and 113

Study Arms (2)

LY3113593

EXPERIMENTAL

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

Drug: LY3113593

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3113593 DRUG

Administered by slow intravenous (IV) infusion.

LY3113593

Placebo DRUG

Administered by slow intravenous (IV) infusion.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Orlando Clinical Research Center

Orlando, Florida, 32806, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Northwest Louisiana Nephrology

Shreveport, Louisiana, 71101, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78215, United States

Location

Related Publications (1)

• Sheetz M, Barrington P, Callies S, Berg PH, McColm J, Marbury T, Decker B, Dyas GL, Truhlar SME, Benschop R, Leung D, Berg J, Witcher DR. Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease. Br J Clin Pharmacol. 2019 May;85(5):935-948. doi: 10.1111/bcp.13877. Epub 2019 Mar 4.

  PMID: 30677788 DERIVED

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind participant only
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 13, 2015
• Study Start: November 17, 2015
• Primary Completion: June 22, 2016
• Study Completion: June 22, 2016
• Last Updated: March 21, 2019
• Results First Posted: March 21, 2019

Record last verified: 2018-08

Locations

US (5)