| Trial ID: | L0154 |
| Source ID: | NCT04258397
|
| Associated Drug: |
Pirfenidone
|
| Title: |
Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease
|
| Acronym: |
TOP-CKD
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Pirfenidone|DRUG: matching placebo
|
| Outcome Measures: |
Primary: Change from baseline in kidney fibrosis, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI)., The slope of change in apparent diffusion coefficient of the cortex of the kidney on the diffusion-weighted renal MRI over 12 months., Baseline to Month 12|Change from baseline in kidney fibrosis, as assessed by urinary markers of tubulo-interstitial fibrosis., The slope of change of urine alpha 1 microglobulin (α1M), N-terminal procollagen type 3 peptide (PIIINP), and monocyte chemoattractant protein-1 (MCP-1) over 12 months., Baseline to Month 12 | Secondary: Change from baseline in kidney function, as assessed by eGFR., Change in eGFR will be evaluated as a secondary endpoint, using linear mixed models with random intercepts and slopes. Estimates from the linear mixed models will be interpretable as annual change in slope., Baseline to Month 18|Change from baseline in kidney function, as assessed by urine albumin to creatinine ratio (ACR)., Change in ACR will be evaluated as a secondary endpoint, using linear mixed models with random intercepts and slopes. Estimates from the linear mixed models will be interpretable as annual change in slope. Because urine concentrations of ACR are typically right-skewed, we will use a log transformation to normalize its distribution., Baseline to Month 18
|
| Sponsor/Collaborators: |
Sponsor: Veterans Medical Research Foundation | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|San Diego Veterans Healthcare System|University of California, San Diego|University of California, San Francisco|Genentech, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2020-10-26
|
| Completion Date: |
2024-12
|
| Results First Posted: |
|
| Last Update Posted: |
2022-04-27
|
| Locations: |
VA San Diego Healthcare System, San Diego, California, 92161, United States|University of California, San Francisco, San Francisco, California, 94143, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04258397
|
