Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.
This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
634
immunosuppression
Renal function as assessed by calculated creatinine clearance at month 6.
Time frame: 6 months
Acute rejection: Incidence of and time to first acute rejection
Time frame: 6 months
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Nedlands, Australia
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Perth, Australia
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Linz, Austria
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Linz, Austria
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Vienna, Austria
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Brussels, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Olomouc, Czechia
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Ostrava, Czechia
...and 49 more locations