Trials / Completed
CompletedNCT02408744
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Guadalajara · Academic / Other
- Sex
- All
- Age
- 10 Years – 40 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2010-09-01
- Completion
- 2013-09-01
- First posted
- 2015-04-03
- Last updated
- 2015-04-03
Source: ClinicalTrials.gov record NCT02408744. Inclusion in this directory is not an endorsement.