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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00063583
First Posted: July 2, 2003
Last Update Posted: November 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Intervention Phase
Diabetes Mellitus Diabetic Nephropathy Drug: Pirfenidone Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.:

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 ]

Secondary Outcome Measures:
  • % change in urine albumin excretion from baseline to end of study period. [ Time Frame: 12 months ]
  • % change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period. [ Time Frame: 12 months ]
  • • Determine the relationship between % change in TGF-b1 levels and the change in GFR [ Time Frame: 12 months ]

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
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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Kumar Sharma, UCSD
ClinicalTrials.gov Identifier: NCT00063583     History of Changes
Obsolete Identifiers: NCT00105391
Other Study ID Numbers: 1R01DK063017-01 ( U.S. NIH Grant/Contract )
R01DK063017 ( U.S. NIH Grant/Contract )
First Submitted: June 30, 2003
First Posted: July 2, 2003
Last Update Posted: November 4, 2009
Last Verified: November 2009

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

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Diabetic Nephropathies
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents