| Trial ID: | L6438 |
| Source ID: | NCT00063583
|
| Associated Drug: |
Pirfenidone
|
| Title: |
Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Diabetic Nephropathy
|
| Interventions: |
DRUG: Pirfenidone
|
| Outcome Measures: |
Primary: The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months)., 12 months | Secondary: % change in urine albumin excretion from baseline to end of study period., 12 months|% change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period., 12 months|• Determine the relationship between % change in TGF-b1 levels and the change in GFR, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Sharma, Kumar, M.D. | Collaborators: National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
77
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2003-06
|
| Completion Date: |
2009-03
|
| Results First Posted: |
|
| Last Update Posted: |
2009-11-04
|
| Locations: |
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), Bethesda, Maryland, 20892, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|The Center for Diabetic Kidney Disease at Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00063583
|
