Open label, randomized, multicenter, intervention trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everolimus.
The primary objective is to test the hypothesis that an age-adapted immunosuppressive regimen targeted at reduced immunosuppression with low calcineurin inhibitor (tacrolimus) exposure in combination with everolimus will result in improved outcome in elderly recipients of A: Kidneys from older deceased donors (\>64 years) and B: Kidneys from living donors (all ages) and younger deceased donors (\<65 years).
Who can participate
Age range65 Years – 99 Years
SexALL
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Inclusion criteria
✓. Written informed consent must be obtained before any assessment is performed
✓. Male or female subject ≥65 years old
✓. Subject randomized within 24 hours of completion of transplant surgery
✓. Stratum A: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged 65 years or older
✓. Stratum B: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged below 65 years or a living donor of any age
Exclusion criteria
✕. Subject is a multi-organ transplant recipient
✕. Recipient of bloodgroup ABO incompatible allograft or CDC cross-match positive transplant
✕. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity
. Recipient of a kidney with a cold ischaemia time (CIT) \>24 hr
✕. Recipients of a kidney from an HLA-identical related living donor
✕. Known intolerability for one or more of the study drugs
✕. Subject who is HIV positive
✕. HBsAg and/or a HCV positive subject with evidence of elevated liver function tests (ALT/AST levels ≥2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable