A Study of LY3113593 in Participants With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3113593
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Kidney Disease
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
Sites / Locations
- Orlando Clinical Research Center
- Indiana University School of Medicine
- Northwest Louisiana Nephrology
- DaVita Clinical Research
- Clinical Advancement Center, PLLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY3113593
Placebo
Arm Description
Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A.
0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
PK: Area Under the Concentration Versus Time (AUCτ)
Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W)
Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)
Number of Participants With Anti-LY3113593 Antibodies Detection
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.
Full Information
NCT ID
NCT02604160
First Posted
November 11, 2015
Last Updated
March 19, 2019
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT02604160
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 17, 2015 (undefined)
Primary Completion Date
June 22, 2016 (Actual)
Study Completion Date
June 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single-blind participant only
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3113593
Arm Type
Experimental
Arm Description
Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A.
Intervention Type
Drug
Intervention Name(s)
LY3113593
Intervention Description
Administered by slow intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by slow intravenous (IV) infusion.
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
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.
Time Frame
Baseline through Day 29
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
Time Frame
Predose; 0.5, 4 hours post-dose
Title
PK: Area Under the Concentration Versus Time (AUCτ)
Description
Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W)
Time Frame
Predose; 0.5, 4 hours post-dose
Title
Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)
Time Frame
Predose; 0.5, 4 hours post-dose
Title
Number of Participants With Anti-LY3113593 Antibodies Detection
Description
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.
Time Frame
Day 1: Predose; Day 15, 29, 57, 85 and 113
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Northwest Louisiana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30677788
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.
Results Reference
derived
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A Study of LY3113593 in Participants With Chronic Kidney Disease
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