Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00228020 | Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients | PHASE3 | COMPLETED | 212 | — | — | May 1, 2001 | - | Aug 25, 2010 | - | — |
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).
| Arm | Type | Description |
|---|---|---|
| Basiliximab | EXPERIMENTAL | Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids |
| Basiliximab-free | ACTIVE_COMPARATOR | Patients will be on a regimen of MMF, cyclosporine and steroids. |
| Name | Type | Description |
|---|---|---|
| basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent) | DRUG | - |
| MMF, cyclosporine, steroids | DRUG | - |
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...