INVESTIGATING NEW ONSET DIABETES MELLITUS IN KIDNEY TRANSPLANT RECIPIENTS RECEIVING AN ADVAGRAF-BASED IMMUNOSUPPRESSIVE REGIMEN WITH OR WITHOUT CORTICOSTEROIDS – A MULTICENTER, TWO ARM, RANDOMIZED, O...

Update Il y a 4 ans
Reference: EUCTR2010-019638-28

INVESTIGATING NEW ONSET DIABETES MELLITUS IN KIDNEY TRANSPLANT RECIPIENTS RECEIVING AN ADVAGRAF-BASED IMMUNOSUPPRESSIVE REGIMEN WITH OR WITHOUT CORTICOSTEROIDS – A MULTICENTER, TWO ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY

Woman and Man

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Extract

To compare the two treatment arms with regard to incidence of new onset diabetes Mellitus as per the American Diabetic Association criteria at any point up to 24 weeks after kidney transplantation. Arm 1: Advagraf + Basiliximab + MMF + Steroids (discontinued at 10 days) Arm 2: Advagraf + Basiliximab + MMF + Steroids (optional intra-op Bolus only)


Inclusion criteria

  • Prophylaxis of rejection in kidney allograft recipients (by immunosuppression)