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Home > "P" Clinical Trials Conditions > Pirfenidone: A New Drug to Treat Kidney Disease in Patients with Diabetes  Pirfenidone: A New Drug to Treat Kidney Disease in Patients with Diabetes
Pirfenidone: A New Drug to Treat Kidney Disease in Patients with Diabetes
For Condition: Diabetic Nephropathy,Diabetes Mellitus
Status: Recruiting
Sponsor(s): Sharma, Kumar, M.D. , National Institutes of Health (NIH),National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),InterMune
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 120
Location and Contact Information:
The Center for Diabetic Kidney Disease at Thomas Jefferson University *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Barbara Francos 215-503-3000
Additional Information:
Study ID Numbers: 1-RO1-DK63017-01;
Study Start Date: June 2003
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063583
Other Diabetes Mellitus Studies:
1. Patterns and natural history of insulin secretion in islet cell transplant recipients and controls
2. Long Term Follow-Up of Diabetic Retinopathy
3. Central Obesity and Disease Risk in Japanese Americans
4. Urinary Vitamin C Loss in Diabetic Subjects
5. Proactive Diabetes Case Management
Related Studies:
Other Diabetes Mellitus Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Pirfenidone: A New Drug to Treat Kidney Disease in Patients with Diabetes
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