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

University of Guadalajara

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Kidney Disease; Fibrosis

Treatments: Drug: Pirfenidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02408744

Pirfenidona 001

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 10 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Pirfenidone

Experimental group

Description:

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.

Treatment:

Drug: Pirfenidone