Clinical trial NCT02604160: A Study of LY3113593 in Participants With Chronic Kidney Disease
Official title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 29
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
timeFrame: Predose; 0.5, 4 hours post-dose
measure: PK: Area Under the Concentration Versus Time (AUCτ)
timeFrame: Predose; 0.5, 4 hours post-dose
measure: Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)
timeFrame: Predose; 0.5, 4 hours post-dose
measure: Number of Participants With Anti-LY3113593 Antibodies Detection
timeFrame: Day 1: Predose; Day 15, 29, 57, 85 and 113
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.