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

This study has been completed.
Information provided by:
Sharma, Kumar, M.D.
ClinicalTrials.gov Identifier:
First received: June 30, 2003
Last updated: November 3, 2009
Last verified: November 2009

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
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:

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
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.


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


  • 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


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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.
Principal Investigator: Kumar Sharma, M.D. UCSD
  More Information

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
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
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 October 19, 2014