Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients

Novartis212 enrolled

Overview

The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

212

Conditions

Pediatric Kidney Transplantation

Interventions

basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)DRUG

MMF, cyclosporine, steroidsDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are recipients of primary or secondary renal allograft. * Patients who are single-organ recipients (kidney only). Exclusion Criteria: •Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Time to first BPAR episode or treatment failure

Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy).

Time frame: 6 months

Data from ClinicalTrials.gov

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