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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408744
• Other study ID #: Pirfenidona 001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 31, 2015
• Last updated: April 2, 2015
• Start date: September 2009
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Health authority: México:Regulatory Authorities and Ethics Committees from the Centro de Estudios de Investigación Básica y Clínica S.C. and the Hospital Real San José
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 40 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Fibrosis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.	The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO.	three years	No
Secondary	Effect of the use of Pirfenidone in renal function	The renal function was monitored by cystatin C, reciprocal of serum creatinine and creatinine clearance collection of 24 hrs.	Three years	No