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

Sharma, Kumar, M.D.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Nephropathy; Diabetes Mellitus

Treatments: Drug: Pirfenidone

Study type: Interventional

Funder types: NIH

Identifiers

NCT00063583

R01DK063017 (U.S. NIH Grant/Contract)

1R01DK063017-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Pirfenidone

Pirfenidone 1200 mg/day

Experimental group

Description:

Pirfenidone will be administered at a dose of 1200 mg/day

Treatment:

Drug: Pirfenidone

Pirfenidone 2400 mg/day

Experimental group

Description:

Pirfenidone will be administered at 2400 mg/day

Treatment:

Drug: Pirfenidone