| Trial ID: | L0224 |
| Source ID: | NCT01427972
|
| Associated Drug: |
Ly2623091
|
| Title: |
A Study of LY2623091 in Male and Females With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01427972/results
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: LY2623091|DRUG: Eplerenone
|
| Outcome Measures: |
Primary: Change From Baseline to Day 21 in Proteinuria Based on 24-hours Pooled Urine, Proteinuria was the presence of excess serum protein in the urine. Proteinuria was calculated for each participant after each treatment period. Change was calculated as (Day 21 post-treatment value) minus (baseline value)., Over 24 hours at Baseline and on Day 21 | Secondary: Change From Baseline to Day 21 in Potassium Clearance Following an Oral Potassium Challenge, Urine potassium clearance is defined as the amount of renal potassium excreted per volume of urine from participant's pooled urine. The oral potassium challenge consisted of 35 milliequivalents (mEq) potassium administered over 10 minutes as a flavored potassium chloride solution. Change was calculated as (Day 21 values) minus (baseline values)., Over 0-6 hours at Baseline and on Day 21|Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve During the Dosing Period of LY2623091 (AUC0-τ), Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2|PK: Maximum Plasma Concentration (Cmax) of LY2623091, Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2 | Other: The Number of Participants Who Died While on Study, Baseline up to end of Treatment Period 2 plus 10-day follow-up (80 days)
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-09
|
| Completion Date: |
2013-03
|
| Results First Posted: |
2019-06-03
|
| Last Update Posted: |
2019-09-09
|
| Locations: |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sofia, 1612, Bulgaria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bloemfontein, 9300, South Africa|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Newton Park, 6045, South Africa|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pretoria, 0184, South Africa
|
| URL: |
https://clinicaltrials.gov/show/NCT01427972
|
