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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

Conditions
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Diabetes Mellitus, Diabetic Nephropathy

Intervention / Treatment
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* Drug: Pirfenidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Pirfenidone<br>* Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses<br>|
| Experimental: Pirfenidone 1200 mg/day<br>Pirfenidone will be administered at a dose of 1200 mg/day | Drug: Pirfenidone<br>* Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses<br>|
| Experimental: Pirfenidone 2400 mg/day<br>Pirfenidone will be administered at 2400 mg/day | Drug: Pirfenidone<br>* Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney disease