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

NCT02408744 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-03

No results posted yet for this study

Summary

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 Disease (CKD).

Conditions

Interventions

DRUG

Pirfenidone

Pirfenidone was supplied orally in the form of prolonged-released tablets according with body surface area (m2 BS) of each patient. The target dosage of PFD was 1200 mg two times a day (b.i.d.) for a full dosage of 2400 mg daily during three years. Therapy was initiated at 600 mg b.i.d. and escalated to full dosage after 3 weeks when symptoms were controlled.

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • Juan Armendariz-Borunda, Ph.D. · Head, Molecular Biology and Genomics Department, University of Guadalajara

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2013-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408744 on ClinicalTrials.gov