Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.
The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
267
Immunosuppression
Unnamed facility
Brussels, Belgium
Unnamed facility
Renal function measured by creatinine clearance
Time frame: 6 months
Acute rejection
Time frame: 6 months
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Leuven, Belgium
Unnamed facility
Bordeaux, France
Unnamed facility
Clermont-Ferrand, France
Unnamed facility
Créteil, France
Unnamed facility
Le Kremlin-Bicêtre, France
Unnamed facility
Montpellier, France
Unnamed facility
Nice, France
Unnamed facility
Suresnes, France
Unnamed facility
Toulouse, France
...and 23 more locations