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

Study Overview
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Brief Summary
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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).

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

Conditions
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Fibrosis, Chronic Kidney Disease

Intervention / Treatment
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* Drug: Pirfenidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pirfenidone<br>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<br>* 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.<br>* Other names: 5-methyl-1-phenyl-2-(1H)-pyridone;|

What is the study measuring?
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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. | 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 | The renal function was monitored by cystatin C, reciprocal of serum creatinine and creatinine clearance collection of 24 hrs. | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nephroprotection, pirfenidone, polymorphisms