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

Phase 3

Completed

• Conditions: Pediatric Kidney Transplantation
• Interventions: Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent); Drug: MMF, cyclosporine, steroids

• Registration Number: NCT00228020
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Primary Completion: 2006-01
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-24
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basiliximab	basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)	Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids
Basiliximab-free	MMF, cyclosporine, steroids	Patients will be on a regimen of MMF, cyclosporine and steroids.

Primary Outcome Measures

Name	Time	Method
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).