Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sharma, Kumar, M.D.
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Pirfenidone

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