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COMPLETEDPhase 1/2NCT02408744

Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease

The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Diseas...

Lead sponsor: University of Guadalajara•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Guadalajara

Collaborators

Cell Therapy And Technology, S.a. De C.v.

Age

10 - 40 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Patients between 10 and 40 years old with CKD
•2. Diagnosis of CKD stage 1 to 4 according with KDIGO definition and classification
•3. No glucocorticoids, cyclophasphamide, mycophenolate, or other immunosuppressive drugs for at least two months before starting PFD administration
•4. Sign of consent forms

Exclusion Criteria

•1. Known intolerance to PFD
•2. CKD stage V according with KDOQI classification
•3. Post-transplant patients
•4. History of peptic ulcer within six months
•5. History of cerebrovascular disease within six months
•6. Evidence of hepatic disease
•7. Pregnancy or breast feeding
•8. Malignancy

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 3, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1/PHASE2

Enrollment30

Start dateSep 2009

Last updatedApr 3, 2015

Condition

Fibrosis Chronic Kidney Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2015Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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