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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01028092 | mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation | PHASE3 | COMPLETED | 327 | — | — | Mar 1, 2009 | Jul 1, 2014 | Jul 8, 2014 | 18 | France |
| Arm | Type | Description |
|---|---|---|
| Control | ACTIVE_COMPARATOR | anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids |
| CNI-free | EXPERIMENTAL | Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids |
| Switch | EXPERIMENTAL | anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids |
| Name | Type | Description |
|---|---|---|
| Anti R-IL2 + Cyclosporine | DRUG | * anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) * Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 * cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2 * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6 |
| Thymoglobulin + Everolimus | DRUG | * Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days * Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 * everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6 |
| Anti R-IL2 + Cyclosporine then Everolimus | DRUG | * anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) * Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0 * cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6 |
Inclusion Criteria: * Patient who has given written informed consent to participate in the study * First or second single transplantation of a recipient (male or female) older than 60 years old * Donor older than 60 years old * PRA \< 30% Exclusion Criteria: * Living donor * Third transplantation...