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
|Condition or disease||Intervention/treatment||Phase|
|Fibrosis Chronic Kidney Disease||Drug: Pirfenidone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 Name: 5-methyl-1-phenyl-2-(1H)-pyridone
- 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.
- 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.
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
|Study Director:||Juan Armendariz-Borunda, Ph.D.||Head, Molecular Biology and Genomics Department, University of Guadalajara|