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12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in d...

Update Il y a 5 ans
Reference: EUCTR2005-003494-25

12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in de novo renal transplant recipients

Woman and Man

  • | Country :
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  • | organs :
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  • | Specialty :
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Extract

The primary objective of the study is to demonstrate that in de novo renal transplant patients, at least one of the AEB071 treatment regimens is not inferior to the control treatment (myfortic® + tacrolimus) within 6 months of the initial dose of study drug with respect to primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up.

Inclusion criteria

  • First evaluation of the efficacy and safety of AEB071 in its target indication: prevention of rejection in solid organ tranplantation. The study population will consist of a representative group of male and female de novo renal transplant patients

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