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

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ClinicalTrials.gov Identifier: NCT02408744
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Cell Therapy And Technology, S.a. De C.v.
Information provided by (Responsible Party):
Juan Armendáriz-Borunda, University of Guadalajara

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).

Condition or disease Intervention/treatment Phase
Fibrosis Chronic Kidney Disease Drug: Pirfenidone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Pirfenidone

Arm Intervention/treatment
Experimental: Pirfenidone
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
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.
Other Name: 5-methyl-1-phenyl-2-(1H)-pyridone




Primary Outcome Measures :
  1. Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease. [ Time Frame: three years ]
    The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO.


Secondary Outcome Measures :
  1. Effect of the use of Pirfenidone in renal function [ Time Frame: Three years ]
    The renal function was monitored by cystatin C, reciprocal of serum creatinine and creatinine clearance collection of 24 hrs.



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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408744


Sponsors and Collaborators
University of Guadalajara
Cell Therapy And Technology, S.a. De C.v.
Investigators
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Study Director: Juan Armendariz-Borunda, Ph.D. Head, Molecular Biology and Genomics Department, University of Guadalajara

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Responsible Party: Juan Armendáriz-Borunda, Head, Molecular Biology and Genomics Departament, CUCS, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02408744     History of Changes
Other Study ID Numbers: Pirfenidona 001
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015
Keywords provided by Juan Armendáriz-Borunda, University of Guadalajara:
nephroprotection
pirfenidone
polymorphisms
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents