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

Phase 1

Completed

• Conditions: Diabetic Nephropathy; Diabetes Mellitus
• Interventions: Drug: Pirfenidone

• Registration Number: NCT00063583
• Lead Sponsor: Sharma, Kumar, M.D.

Brief 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-06-30
• Study First Submitted QC: 2003-07-01
• Study First Posted: 2003-07-02
• Primary Completion: 2007-11
• Study Completion: 2009-03
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-03
• Last Update Posted: 2009-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Pirfenidone	Placebo
Pirfenidone 1200 mg/day	Pirfenidone	Pirfenidone will be administered at a dose of 1200 mg/day
Pirfenidone 2400 mg/day	Pirfenidone	Pirfenidone will be administered at 2400 mg/day

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months).	12 months

Secondary Outcome Measures

Name	Time	Method
% 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

Trial Locations

Locations (3)

National Institute of Diabetes and Digestive and Kidney Disease (NIDDK); 🇺🇸 Bethesda, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

The Center for Diabetic Kidney Disease at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States