- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408744
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
April 2, 2015 updated by: Juan Armendáriz-Borunda, University of Guadalajara
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Juan Armendariz-Borunda, Ph.D., Head, Molecular Biology and Genomics Department, University of Guadalajara
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 31, 2015
First Submitted That Met QC Criteria
April 2, 2015
First Posted (Estimate)
April 3, 2015
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
April 2, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- Pirfenidona 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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