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

Sponsor:	Sharma, Kumar, M.D.
Collaborators:	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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems

Drug Information available for: Pirfenidone

U.S. FDA Resources

Further study details as provided by Sharma, Kumar, M.D.:

Primary Outcome Measures:

The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

% change in urine albumin excretion from baseline to end of study period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
% change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Determine the relationship between % change in TGF-b1 levels and the change in GFR [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	77
Study Start Date:	June 2003
Study Completion Date:	March 2009
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo	Drug: Pirfenidone Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses Other Name: Pirfenidone
Experimental: Pirfenidone 1200 mg/day Pirfenidone will be administered at a dose of 1200 mg/day	Drug: Pirfenidone Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses Other Name: Pirfenidone
Experimental: Pirfenidone 2400 mg/day Pirfenidone will be administered at 2400 mg/day	Drug: Pirfenidone Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses Other Name: Pirfenidone

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

Locations

United States, Maryland
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
Bethesda, Maryland, United States, 20892
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
The Center for Diabetic Kidney Disease at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

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.

UCSD

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.

Responsible Party:	Kumar Sharma, UCSD
ClinicalTrials.gov Identifier:	NCT00063583 History of Changes
Obsolete Identifiers:	NCT00105391
Other Study ID Numbers:	1-RO1-DK63017-01, R01DK063017
Study First Received:	June 30, 2003
Last Updated:	November 3, 2009
Health Authority:	United States: Food and Drug Administration

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

Kidney disease

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Pirfenidone
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012