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Sponsors and Collaborators: |
Sharma, Kumar, M.D. National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Sharma, Kumar, M.D. |
ClinicalTrials.gov Identifier: | NCT00063583 |
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 |
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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 |
Estimated Enrollment: | 120 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | July 2007 |
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 |
Inclusion
Exclusion
Contact: Kumar Sharma, M.D. | 215-503-3000 | kumar.sharma@jefferson.edu |
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 |
Principal Investigator: | Kumar Sharma, M.D. | Thomas Jefferson University |
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 |
Kidney disease |
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 |
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 |