Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
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The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus Diabetic Nephropathy |
Drug: Pirfenidone |
Phase 1 Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
Official Title: | Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy |
- The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- % change in urine albumin excretion from baseline to end of study period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- % change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- • Determine the relationship between % change in TGF-b1 levels and the change in GFR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Enrollment: | 77 |
Study Start Date: | June 2003 |
Study Completion Date: | March 2009 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo
Placebo
|
Drug: Pirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Other Name: Pirfenidone
|
Experimental: Pirfenidone 1200 mg/day
Pirfenidone will be administered at a dose of 1200 mg/day
|
Drug: Pirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Other Name: Pirfenidone
|
Experimental: Pirfenidone 2400 mg/day
Pirfenidone will be administered at 2400 mg/day
|
Drug: Pirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Other Name: Pirfenidone
|
Detailed Description:
Diabetic kidney disease is the leading cause of new cases of kidney failure in the United States. In the kidneys of diabetic patients, there is accumulation of protein that leads to the formation of scar tissue and poor kidney function. Because of this many patients eventually require dialysis or kidney transplantation. A new investigational drug, pirfenidone, has been shown to be beneficial in a number of diseases in which scar formation leads to disease progression. It is our goal to examine whether pirfenidone is effective at stabilizing or reducing progressive diabetic kidney dysfunction.
![](https://webarchive.library.unt.edu/web/20130218210643im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion
- Type 1 or type 2 diabetes
- Males and females greater than or equal to 18 years.
- Abnormal kidney function determined by glomerular filtration rate
- History of proteinuria
- Blood pressure controlled to <140/90 on anti-hypertensive medication
Exclusion
- Cancer, liver disease, hepatitis, HIV+
- History of heart attack, unstable angina, stroke or peptic ulcer in the past 6 months
- Pregnant or planning to become pregnant during the study period
- Other known kidney disease besides diabetic nephropathy
- Expect to begin dialysis or receive a kidney transplant within 1 year of study enrollment
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United States, Maryland | |
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) | |
Bethesda, Maryland, United States, 20892 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Pennsylvania | |
The Center for Diabetic Kidney Disease at Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Kumar Sharma, M.D. | UCSD |
![](https://webarchive.library.unt.edu/web/20130218210643im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Responsible Party: | Kumar Sharma, UCSD |
ClinicalTrials.gov Identifier: | NCT00063583 History of Changes |
Obsolete Identifiers: | NCT00105391 |
Other Study ID Numbers: | 1-RO1-DK63017-01, R01DK063017 |
Study First Received: | June 30, 2003 |
Last Updated: | November 3, 2009 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sharma, Kumar, M.D.:
Kidney disease |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetic Nephropathies Kidney Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Diabetes Complications Pirfenidone Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on February 14, 2013