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

A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00228020

Enrollment

212

Registered

2005-09-28

Start date

2001-05-31

Completion date

Unknown

Last updated

2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Kidney Transplantation

Keywords

pediatric, kidney transplantation, basiliximab

Brief summary

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.

Interventions

DRUGbasiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)

DRUGMMF, cyclosporine, steroids

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Time to first BPAR episode or treatment failure	6 months	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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026