| Trial ID: | L0271 |
| Source ID: | NCT02604160
|
| Associated Drug: |
Ly3113593
|
| Title: |
A Study of LY3113593 in Participants With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02604160/results
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: LY3113593|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593, Predose; 0.5, 4 hours post-dose|PK: Area Under the Concentration Versus Time (AUCτ), Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W), 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, 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., Day 1: Predose; Day 15, 29, 57, 85 and 113
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2015-11-17
|
| Completion Date: |
2016-06-22
|
| Results First Posted: |
2019-03-21
|
| Last Update Posted: |
2019-03-21
|
| Locations: |
Orlando Clinical Research Center, Orlando, Florida, 32806, United States|Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States|Northwest Louisiana Nephrology, Shreveport, Louisiana, 71101, United States|DaVita Clinical Research, Minneapolis, Minnesota, 55404, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02604160
|
