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A MULTICENTRE, RANDOMISED, OPEN CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF A COMBINATION THERAPY OF TACROLIMUS WITH SIROLIMUS VERSUS TACROLIMUS WITH MYCOPHENOLATE MOFETIL IN KIDNEY TRANSPLAN...

Update Il y a 4 ans
Reference: EUCTR2004-000457-34

A MULTICENTRE, RANDOMISED, OPEN CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF A COMBINATION THERAPY OF TACROLIMUS WITH SIROLIMUS VERSUS TACROLIMUS WITH MYCOPHENOLATE MOFETIL IN KIDNEY TRANSPLANTATION

Woman and Man

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Extract

Primary objective of this study is to compare the two therapy regimens (Arm 1: tacrolimus + sirolimus + corticosteroids, Arm 2: tacrolimus + MMF + corticosteroids)with regard to renal function by using calculated creatinine clearance. The aim is to demonstrate that Arm 1 is non-inferior to Arm 2 with regard to the primary endpoint.

Inclusion criteria

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

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