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

Novartis

Status and phase: Completed; Phase 3

Conditions: Pediatric Kidney Transplantation

Treatments: Drug: MMF, cyclosporine, steroids; Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00228020

CCHI621ADE01

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 2 patient groups

Basiliximab

Experimental group

Description:

Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids

Treatment:

Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)

Basiliximab-free

Active Comparator group

Description:

Patients will be on a regimen of MMF, cyclosporine and steroids.

Treatment:

Drug: MMF, cyclosporine, steroids