Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes - Full Text View

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	Intervention	Phase
Diabetes Mellitus Diabetic Nephropathy	Drug: Pirfenidone	Phase I Phase II

MedlinePlus related topics:

Diabetes Diabetic Kidney Problems

ChemIDplus related topics:

Pirfenidone

U.S. FDA Resources

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 as provided by Sharma, Kumar, M.D.:

Estimated Enrollment:	120
Study Start Date:	June 2003
Estimated Study Completion Date:	July 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063583

Contacts


Contact: Kumar Sharma, M.D.	215-503-3000	kumar.sharma@jefferson.edu

Locations


United States, Maryland
	National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)	Recruiting
	Bethesda, Maryland, United States, 20892
	Contact: Patient recruitment and Public Liason Office 800-411-1010 prpl@mail.cc.nih.gov
	Principal Investigator: Monique Cho, MD

United States, Minnesota
	Mayo Clinic	Recruiting
	Rochester, Minnesota, United States, 55905
	Contact: Shirley Jennison 507-255-0231 Jennison.shirley@mayo.edu
	Principal Investigator: Fernando Fervenza, MD

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

Sponsors and Collaborators

Sharma, Kumar, M.D.

National Institutes of Health (NIH)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Principal Investigator:	Kumar Sharma, M.D.	Thomas Jefferson University

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
First Received:	June 30, 2003
Last Updated:	September 27, 2007
ClinicalTrials.gov Identifier:	NCT00063583
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sharma, Kumar, M.D.:

Kidney disease

Study placed in the following topic categories:

Pirfenidone

Metabolic Diseases

Diabetic Nephropathies

Urologic Diseases

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Kidney Diseases

Metabolic disorder

Glucose Metabolism Disorders

Diabetes Complications

Cicatrix

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antineoplastic Agents

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents

Analgesics

Antirheumatic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Sharma, Kumar, M.D. National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Sharma, Kumar, M.D.
ClinicalTrials.gov Identifier:	NCT00063583