Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
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|ClinicalTrials.gov Identifier: NCT00228020|
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : August 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Kidney Transplantation||Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent) Drug: MMF, cyclosporine, steroids||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||May 2001|
|Actual Primary Completion Date :||January 2006|
Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids
Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)
Active Comparator: Basiliximab-free
Patients will be on a regimen of MMF, cyclosporine and steroids.
Drug: MMF, cyclosporine, steroids
- Time to first BPAR episode or treatment failure [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228020