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Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00063583

Public ClinicalTrials.gov record NCT00063583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00063583
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Sharma, Kumar, M.D.
Individual
Enrollment
77 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2003
Primary completion
Oct 31, 2007
Completion
Feb 28, 2009
Last update posted
Nov 3, 2009

2003 – 2009

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) Bethesda Maryland 20892
Mayo Clinic Rochester Minnesota 55905
The Center for Diabetic Kidney Disease at Thomas Jefferson University Philadelphia Pennsylvania 19107

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00063583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2009 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00063583 live on ClinicalTrials.gov.

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