NCT00063583

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

Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Sharma, Kumar, M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetes Mellitus
• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Pirfenidone	Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-11-01
• Completion: 2009-03-01
• First posted: 2003-07-02
• Last updated: 2009-11-04

Locations

3 sites across 1 country: United States