Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MMF, cyclosporine, steroids · 1 trial · 1 indication
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...
MMF+ full-dose Neoral+ corticosteroids is a combination regimen studied for use in kidney transplantation, including pediatric kidney transplantation. It combines mycophenolate mofetil, cyclosporine microemulsion, and prednisone. The regimen was evaluated in Phase 3 clinical trials for these indications.
MMF+ full-dose Neoral+ corticosteroids is developed by Novartis AG, which trades under the ticker NVS. The company sponsored clinical trials of this combination regimen in kidney transplant patients.
MMF+ full-dose Neoral+ corticosteroids has completed Phase 3 clinical trials. It is an investigational combination regimen and remains in clinical development. No approval status has been reported for this regimen.
MMF+ full-dose Neoral+ corticosteroids was studied in two completed Phase 3 trials. NCT00099736 enrolled 696 adult kidney transplant patients in the United States. NCT00228020 enrolled 212 pediatric kidney transplant recipients aged 1 year and older.
MMF+ full-dose Neoral+ corticosteroids refers to a specific combination of mycophenolate mofetil, full-dose cyclosporine microemulsion (Neoral), and corticosteroids. This regimen was used as a comparator in trials testing other immunosuppressive agents in kidney transplantation.