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

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).

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Key information

Conditions

Fibrosis Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

10 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

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: 5-methyl-1-phenyl-2-(1H)-pyridone

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

Cell Therapy And Technology, S.a. De C.v.

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2013
First posted: Apr 3, 2015
Registry last updated: Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed