Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of first episodes of BPAR at month 3 post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of patients death at month 3 post transplant. | ||
| Incidence of graft loss or, synonymously, graft failure) | ||
| The allograft will defined as lost (or: to have failed) |
Not provided
Inclusion Criteria:
- Age 18-70 years old
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| when the patient begins dialysis treatments without |
| subsequent graft recovery. |
| The time of graft failure will be defined as the time of start of dialysis, or time of nephrectomy, whatever occurs first. |
| Number of myfortic dose adjustments/discontinuations |