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Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
This study is currently recruiting participants.
Verified by Sharma, Kumar, M.D., June 2006
First Received: June 30, 2003   Last Updated: September 27, 2007   History of Changes
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
  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: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title: Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

Resource links provided by NLM:


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

Publications:
Study ID Numbers: 1-RO1-DK63017-01
Study First Received: June 30, 2003
Last Updated: September 27, 2007
ClinicalTrials.gov Identifier: NCT00063583     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Diabetic Nephropathies
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Pirfenidone
Urologic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Kidney Diseases
Endocrinopathy
Analgesics
Antirheumatic Agents
Glucose Metabolism Disorders
Metabolic Disorder
Diabetes Complications
Cicatrix

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Diabetic Nephropathies
Metabolic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Pharmacologic Actions
Pirfenidone
Urologic Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Kidney Diseases
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Glucose Metabolism Disorders
Central Nervous System Agents
Diabetes Complications

ClinicalTrials.gov processed this record on September 02, 2009