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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02408744

Enrollment

Registered

2015-04-03

Start date

2009-09-30

Completion date

2013-09-30

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Fibrosis

Keywords

nephroprotection, pirfenidone, polymorphisms

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).

Interventions

DRUGPirfenidone

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026