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

Phase 1

Completed

• Conditions: Fibrosis; Chronic Kidney Disease
• Interventions: Drug: Pirfenidone

• Registration Number: NCT02408744
• Lead Sponsor: University of Guadalajara

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-09
• Study Completion: 2013-09
• Status Verified: 2015-03
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Study First Posted: 2015-04-03
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pirfenidone	Pirfenidone	Pirfenidone 1200 mg in the form of prolonged-released tablets, orally administered two times a day (b.i.d.) to yield a daily dose of 2400 mg during three years.

Primary Outcome Measures

Name	Time	Method
Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.	three years	The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO.

Secondary Outcome Measures

Name	Time	Method
Effect of the use of Pirfenidone in renal function	Three years	The renal function was monitored by cystatin C, reciprocal of serum creatinine and creatinine clearance collection of 24 hrs.