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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Guadalajara
• Collaborator: Cell Therapy And Technology, S.a. De C.v.
• Treatments: Pirfenidone

Criteria

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