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
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.
Clinical Details
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
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: May 2001
Last updated: July 18, 2007
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