Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy
2 other identifiers
interventional
77
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus
Started Jun 2003
Longer than P75 for phase_1 diabetes-mellitus
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 30, 2003
CompletedFirst Posted
Study publicly available on registry
July 2, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedNovember 4, 2009
November 1, 2009
4.4 years
June 30, 2003
November 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months).
12 months
Secondary Outcomes (3)
% change in urine albumin excretion from baseline to end of study period.
12 months
% change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period.
12 months
• Determine the relationship between % change in TGF-b1 levels and the change in GFR
12 months
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
Pirfenidone 1200 mg/day
EXPERIMENTALPirfenidone will be administered at a dose of 1200 mg/day
Pirfenidone 2400 mg/day
EXPERIMENTALPirfenidone will be administered at 2400 mg/day
Interventions
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
Bethesda, Maryland, 20892, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The Center for Diabetic Kidney Disease at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Publications (6)
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.
PMID: 9133555BACKGROUNDShimizu 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
BACKGROUNDShimizu 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.
PMID: 9407470BACKGROUNDIyer 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.
PMID: 10490926BACKGROUNDMcGowan 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
BACKGROUNDRaghu 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.
PMID: 10194146BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kumar Sharma, M.D.
UCSD
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
June 30, 2003
First Posted
July 2, 2003
Study Start
June 1, 2003
Primary Completion
November 1, 2007
Study Completion
March 1, 2009
Last Updated
November 4, 2009
Record last verified: 2009-11