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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab; Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Prednisone

Criteria

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.