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

Primary Purpose

Fibrosis, Chronic Kidney Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Pirfenidone
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrosis focused on measuring nephroprotection, pirfenidone, polymorphisms

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pirfenidone

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 31, 2015
    Last Updated
    April 2, 2015
    Sponsor
    University of Guadalajara
    Collaborators
    Cell Therapy And Technology, S.a. De C.v.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02408744
    Brief Title
    Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
    Official Title
    Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Guadalajara
    Collaborators
    Cell Therapy And Technology, S.a. De C.v.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibrosis, Chronic Kidney Disease
    Keywords
    nephroprotection, pirfenidone, polymorphisms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pirfenidone
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Pirfenidone
    Other Intervention Name(s)
    5-methyl-1-phenyl-2-(1H)-pyridone
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.
    Description
    The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO.
    Time Frame
    three years
    Secondary Outcome Measure Information:
    Title
    Effect of the use of Pirfenidone in renal function
    Description
    The renal function was monitored by cystatin C, reciprocal of serum creatinine and creatinine clearance collection of 24 hrs.
    Time Frame
    Three years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Armendariz-Borunda, Ph.D.
    Organizational Affiliation
    Head, Molecular Biology and Genomics Department, University of Guadalajara
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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