CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
Pirfenidonedrug
Likely dose
Pirfenidone 2400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00063583
NCT00063583Phase 2Completed
CompareCT.gov

Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

Sharma, Kumar, M.D.·interventional·Posted Jul 2, 2003·Updated Nov 4, 2009

In Brief

A Phase 2 clinical trial evaluating Pirfenidone for Diabetes Mellitus and Diabetic Nephropathy. Completed, enrolled 77 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Diabetic Nephropathy
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2003
Enrollment StartJun 1, 2003
Primary CompletionNov 1, 2007
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 23 years ago

Interventions

Pirfenidonedrug

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