Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
NCT ID: NCT00063583
Last Updated: 2009-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
77 participants
INTERVENTIONAL
2003-06-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Pirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Pirfenidone 1200 mg/day
Pirfenidone will be administered at a dose of 1200 mg/day
Pirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Pirfenidone 2400 mg/day
Pirfenidone will be administered at 2400 mg/day
Pirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Interventions
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Pirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sharma, Kumar, M.D.
INDIV
Responsible Party
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UCSD
Principal Investigators
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Kumar Sharma, M.D.
Role: PRINCIPAL_INVESTIGATOR
UCSD
Locations
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National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
Bethesda, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
The Center for Diabetic Kidney Disease at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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References
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Sharma K, Ziyadeh FN, Alzahabi B, McGowan TA, Kapoor S, Kurnik BR, Kurnik PB, Weisberg LS. Increased renal production of transforming growth factor-beta1 in patients with type II diabetes. Diabetes. 1997 May;46(5):854-9. doi: 10.2337/diab.46.5.854.
Shimizu F, Fukagawa M, Yamauchi S, Taniyama M, Komemushi S, Margolin SB, Kurokawa K: Pirfenidone prevents the progression of irreversible glomerular sclerotic lesions in rats. Nephrology 3:315-322, 1997
Shimizu T, Fukagawa M, Kuroda T, Hata S, Iwasaki Y, Nemoto M, Shirai K, Yamauchi S, Margolin SB, Shimizu F, Kurokawa K. Pirfenidone prevents collagen accumulation in the remnant kidney in rats with partial nephrectomy. Kidney Int Suppl. 1997 Dec;63:S239-43.
Iyer SN, Gurujeyalakshmi G, Giri SN. Effects of pirfenidone on transforming growth factor-beta gene expression at the transcriptional level in bleomycin hamster model of lung fibrosis. J Pharmacol Exp Ther. 1999 Oct;291(1):367-73.
McGowan T, Dunn SR, Sharma K: Treatment of db/db mice with pirfenidone leads to improved histology and serum creatinine. J Am Soc Nephrology 11:A2814, 2000
Raghu G, Johnson WC, Lockhart D, Mageto Y. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label Phase II study. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1061-9. doi: 10.1164/ajrccm.159.4.9805017.
Other Identifiers
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