Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
NCT ID: NCT02408744
Last Updated: 2015-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2009-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
10 Years
40 Years
ALL
Yes
Sponsors
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Cell Therapy And Technology, S.a. De C.v.
INDUSTRY
University of Guadalajara
OTHER
Responsible Party
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Juan Armendáriz-Borunda
Head, Molecular Biology and Genomics Departament, CUCS
Principal Investigators
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Juan Armendariz-Borunda, Ph.D.
Role: STUDY_DIRECTOR
Head, Molecular Biology and Genomics Department, University of Guadalajara
Other Identifiers
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Pirfenidona 001
Identifier Type: -
Identifier Source: org_study_id
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