mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

Study Overview
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Brief Summary
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This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).

Official Title
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mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

Conditions
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Renal Transplant

Intervention / Treatment
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* Drug: Anti R-IL2 + Cyclosporine
* Drug: Thymoglobulin + Everolimus
* Drug: Anti R-IL2 + Cyclosporine then Everolimus


Participation Criteria
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Eligibility Criteria
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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 PRA > 30% Other protocol-defined inclusion/exclusion criteria may apply. Recipient of multi-organ transplant Active major infections (HBV, HCV, HIV) Loss of a first graft for immunologic issues Anemia (<9g/l) or leucopenia (<2500/mm3)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids | Drug: Anti R-IL2 + Cyclosporine<br>* 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<br>|
| Experimental: CNI-free<br>Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids | Drug: Thymoglobulin + Everolimus<br>* 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<br>|
| Experimental: Switch<br>anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids | Drug: Anti R-IL2 + Cyclosporine then Everolimus<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calculated renal function with MDRD equation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection rate |  | 12 months | 
| Patient and graft survival rate |  | 12 months | 
| Adverse events |  | 12 months | 
| GFR calculated with Cockcroft Gault formula |  | 12 months |