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Diabetes and Kidney Disease |
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Clinical Trial: Pirfenidone: A New Drug to Treat Kidney Disease in Patients with Diabetes
This study is currently recruiting patients.
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
Expected Total Enrollment: 120
Study start: June 2003; Expected 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
- 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
Location and Contact Information
Pennsylvania
The Center for Diabetic Kidney Disease at Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States; Recruiting
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.
Record last reviewed: June 2003
Last Updated: October 13, 2004
Record first received: June 30, 2003
ClinicalTrials.gov Identifier: NCT00063583
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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