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A MULTICENTRE, 1:1 RANDOMISED, DOUBLE BLIND, TWO ARM PARALLEL GROUP STUDY TO EVALUATE AND COMPARE THE EFFICACY AND SAFETY OF MODIFIED RELEASE TACROLIMUS FK506E (MR4) VERSUS TACROLIMUS FK506 IN COMBINA...

Update Il y a 4 ans
Reference: EUCTR2004-000304-41

A MULTICENTRE, 1:1 RANDOMISED, DOUBLE BLIND, TWO ARM PARALLEL GROUP STUDY TO EVALUATE AND COMPARE THE EFFICACY AND SAFETY OF MODIFIED RELEASE TACROLIMUS FK506E (MR4) VERSUS TACROLIMUS FK506 IN COMBINATION WITH MMF (CELLCEPT®) AND STEROIDS IN PATIENTS UNDERGOING KIDNEY TRANSPLANTATION

Woman and Man

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Extract

The study aims to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Inclusion criteria

  • Patients with end stage kidney disease who will undergo renal transplantation

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