Status:
COMPLETED
Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
Lead Sponsor:
Novartis
Conditions:
Pediatric Kidney Transplantation
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
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 an...
Eligibility Criteria
Inclusion
- Patients who are recipients of primary or secondary renal allograft.
- Patients who are single-organ recipients (kidney only).
Exclusion
- •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.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00228020
Start Date
May 1 2001
Last Update
August 25 2010
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