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Completed

NCT Number: NCT00063583

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

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.

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Key information

Conditions

Diabetes Mellitus Diabetes Complications Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), Bethesda, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses

Primary outcomes

  1. 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 outcomes

  1. % change in urine albumin excretion from baseline to end of study period.

    Time frame: 12 months

  2. % change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period.

    Time frame: 12 months

  3. • Determine the relationship between % change in TGF-b1 levels and the change in GFR

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Sharma, Kumar, M.D.

Indiv

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

Important dates

Study start
2003
Primary completion
2007
Study completion
2009
First posted
Jul 2, 2003
Registry last updated
Nov 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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