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

This study is currently recruiting patients.

Sponsored by: Sharma, Kumar, M.D.
InterMune
Information provided by: Sharma, Kumar, M.D.

Purpose

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.

Condition Treatment or Intervention Phase
Diabetes Mellitus
Diabetic Nephropathy
  Drug: Pirfenidone
 Phase I
Phase II

MedlinePlus related topics:  Diabetes;   Diabetic Kidney Problems

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  120

Study start: June 2003;  Study completion: May 2005

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion

Exclusion


Location and Contact Information


Pennsylvania
      The Center for Diabetic Kidney Disease at Thomas Jefferson University, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Barbara B Francos, RN, BA  215-503-3000    Barbara.Francos@jefferson.edu 
Kumar Sharma, MD,  Principal Investigator
Tracy McGowan, MD,  Sub-Investigator

More Information

Publications

Sharma K, Ziyadeh FN, Alzahabi B, McGowan TA, Kapoor S, Kurnik BR, Kurnik PB, Weisberg LS. Increased renal production of transforming growth factor-beta1 in patients with type II diabetes. Diabetes. 1997 May;46(5):854-9.

Shimizu F, Fukagawa M, Yamauchi S, Taniyama M, Komemushi S, Margolin SB, Kurokawa K: Pirfenidone prevents the progression of irreversible glomerular sclerotic lesions in rats. Nephrology 3:315-322, 1997

Shimizu T, Fukagawa M, Kuroda T, Hata S, Iwasaki Y, Nemoto M, Shirai K, Yamauchi S, Margolin SB, Shimizu F, Kurokawa K. Pirfenidone prevents collagen accumulation in the remnant kidney in rats with partial nephrectomy. Kidney Int Suppl. 1997 Dec;63:S239-43.

Iyer SN, Gurujeyalakshmi G, Giri SN. Effects of pirfenidone on transforming growth factor-beta gene expression at the transcriptional level in bleomycin hamster model of lung fibrosis. J Pharmacol Exp Ther. 1999 Oct;291(1):367-73.

McGowan T, Dunn SR, Sharma K: Treatment of db/db mice with pirfenidone leads to improved histology and serum creatinine. J Am Soc Nephrology 11:A2814, 2000

Raghu G, Johnson WC, Lockhart D, Mageto Y. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label Phase II study. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1061-9.

Study ID Numbers:  1-RO1-DK63017-01
Record last reviewed:  June 2003
Record first received:  June 30, 2003
ClinicalTrials.gov Identifier:  NCT00063583
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-08
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