Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RB 09.074 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
| Genzyme, a Sanofi Company | INDUSTRY |
| Ministry of Health, France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti R-IL2 + Cyclosporine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| calculated renal function with MDRD equation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection rate | 12 months | |
| Patient and graft survival rate | 12 months | |
| Adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yannick LE MEUR, MD/PhD | CHU de Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | France | ||||
| CHU Pellegrin - Bordeaux |
Not provided
| OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Thymoglobulin + Everolimus | Drug |
|
|
| Anti R-IL2 + Cyclosporine then Everolimus | Drug |
|
|
| 12 months |
| GFR calculated with Cockcroft Gault formula | 12 months |
| Bordeaux |
| France |
| CHRU de BREST | Brest | 29609 | France |
| CHU Cote de Nacre | Caen | France |
| CHU Clermont Ferrand | Clermont-Ferrand | France |
| CHU Dijon | Dijon | France |
| CHU Lille | Lille | France |
| CHU Limoges | Limoges | France |
| CHU Montpellier | Montpellier | France |
| CHU Nice | Nice | France |
| AP-HP Hopital Necker | Paris | France |
| CHU Poitiers | Poitiers | France |
| CHU Reims | Reims | France |
| CHU Rennes | Rennes | France |
| CHU Rouen | Rouen | France |
| Hopitaux Universitaires de Strasbourg | Strasbourg | France |
| CHU Rangueil - Toulouse | Toulouse | France |
| CHU Tours | Tours | France |
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| C512542 | thymoglobulin |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided