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

PHASE3CompletedINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

March 31, 2014

Study Completion Date

July 31, 2014

Conditions
Renal Transplant
Interventions
DRUG

Anti R-IL2 + Cyclosporine

"* 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"

DRUG

Thymoglobulin + Everolimus

"* 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"

DRUG

Anti R-IL2 + Cyclosporine then Everolimus

"* 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"

Trial Locations (18)

29609

CHRU de BREST, Brest

Unknown

CHU Amiens, Amiens

CHU Pellegrin - Bordeaux, Bordeaux

CHU Cote de Nacre, Caen

CHU Clermont Ferrand, Clermont-Ferrand

CHU Dijon, Dijon

CHU Lille, Lille

CHU Limoges, Limoges

CHU Montpellier, Montpellier

CHU Nice, Nice

AP-HP Hopital Necker, Paris

CHU Poitiers, Poitiers

CHU Reims, Reims

CHU Rennes, Rennes

CHU Rouen, Rouen

Hopitaux Universitaires de Strasbourg, Strasbourg

CHU Rangueil - Toulouse, Toulouse

CHU Tours, Tours

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

collaborator

Genzyme, a Sanofi Company

INDUSTRY

collaborator

Ministry of Health, France

OTHER_GOV

lead

University Hospital, Brest

OTHER