Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Kidney Transplantation
Intervention: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
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.
Official title: 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
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum age: 1 Year.
Maximum age: 18 Years.
- Patients who are recipients of primary or secondary renal allograft.
- Patients who are single-organ recipients (kidney only).
•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
Locations and Contacts
Starting date: May 2001
Last updated: July 18, 2007