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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
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
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
% change in urine albumin excretion from baseline to end of study period.
Time frame: 12 months
% change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period.
Time frame: 12 months
• Determine the relationship between % change in TGF-b1 levels and the change in GFR
Time frame: 12 months
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