After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood. The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.
Special attention will be paid to the epidemiology of virus infections behind one year post transplant. Very limited data are available on this issue and there is suspicion that tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can induce graft nephropathy and threat to the life of the recipient.
Study Type
OBSERVATIONAL
Enrollment
170
after alemtuzumab, cyclosporine or tacrolimus was administered
National Research Centre of Surgery
Moscow, Russia
Patient Survival
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Time frame: 5 years
Graft Survival
in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
Time frame: 5 years
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