In elderly recipients kidney transplantation is characterized by increased patient mortality and worse kidney function while death censored graft loss is a relatively rare event. This calls for an adapted approach to immunosuppression (IS).
To compare standard IS with a regimen aiming for reduced immunopsuppression and preservation of graft function in elderly transplant recipients.
Randomized controlled trial
Recipients aged 65 and above receiving a kidney allograft from a deceased donor aged 65 and above (part A) or from either a deceased donor below 65 years or a living donor of any age (part B)
INVESTIGATIONAL PRODUCT & COMPARATOR
Standard IS with prednisolon, tacrolimus and mycophenolate mofetil compared with a regimen consisting of prednisolon, very low dose tacrolimus and everolimus.
Primary: successful transplantation at 2 years after transplantation defined as: absence of graft or patient loss in the presence of an eGFR above 30 ml/min (part A) or 45 ml/min (part B).
Kidney function will be assessed as eGFR.
SAMPLE SIZE CALCULATION
To detect a difference of 20% in the endpoint successful transplantation with a power of 80% 192 patients are needed for part A and 180 for part B.
Better renal function is associated with less complications and improved quality of life. These aspects will be integrated in a lifetime economic decision model.