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A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus with MMF (TAC-withdrawal) | Experimental | Everolimus (RAD001) with MMF and Steroids |
|
| Everolimus with reduced TAC | Active Comparator | Everolimus (RAD001) with reduced TAC and Steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAC withdrawal | Drug | Everolimus (RAD001) with MMF and Steroids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function | The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6. | Randomization to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (tBPAR, graft loss, death, loss to follow-up) | Composite efficacy failure of tBPAR, graft loss, death or loss to follow-up and each of its components at month 6 will be analysed per event rate estimates, Kaplan-Meier and regression models. The time to the first occurrence of the event will be calculated from the randomization date. | To Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Routine safety will be assessed via AE reporting, vital signs, and laboratory data. | at 24 months (end of study) |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Everolimus with reduced TAC |
| Drug |
Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids |
|
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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