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

NCT02408744 | Completed Phase 1 DMC

• 1 other identifier: Pirfenidona 001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Fibrosis; Chronic Kidney Disease

Keywords

nephroprotection; pirfenidone; polymorphisms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Effect of the use of Pirfenidone in renal function

  Three years

Study Arms (1)

Pirfenidone

EXPERIMENTAL

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.

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

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.

Also known as: 5-methyl-1-phenyl-2-(1H)-pyridone

Pirfenidone

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 10 and 40 years old with CKD
• Diagnosis of CKD stage 1 to 4 according with KDIGO definition and classification
• No glucocorticoids, cyclophasphamide, mycophenolate, or other immunosuppressive drugs for at least two months before starting PFD administration
• Sign of consent forms

You may not qualify if:

• Known intolerance to PFD
• CKD stage V according with KDOQI classification
• Post-transplant patients
• History of peptic ulcer within six months
• History of cerebrovascular disease within six months
• Evidence of hepatic disease
• Pregnancy or breast feeding
• Malignancy

Sponsors & Collaborators

• University of Guadalajara: lead
• Cell Therapy And Technology, S.a. De C.v.: collaborator

MeSH Terms

Conditions

Fibrosis; Renal Insufficiency, Chronic

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Officials

• Juan Armendariz-Borunda, Ph.D.

  Head, Molecular Biology and Genomics Department, University of Guadalajara

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Molecular Biology and Genomics Departament, CUCS

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2013
• Last Updated: April 3, 2015

Record last verified: 2015-03