Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients
Status:
Completed
Trial end date:
2003-10-01
Target enrollment:
Participant gender:
Summary
Study Phase: IV
Study Type: Open-label, multicenter, randomised clinical trial with two arms stratified for
an intensified immunosuppressive regimen in patients at high risk for acute rejection.
Study Description: 148 kidney transplant recipients at risk for CMV disease were randomized
and treated with ganciclovir capsules for 3 months (Group A, prophylaxis, N=74) or received
ganciclovir IV only in case of proven CMV viral load (Group B, preemptive therapy, N=74).
Initially, a 2 months follow up was planned in this trial. However, the study group decided
to offer a longterm follow up to all patients and amended the protocol, respectively.
The aim of the study was to identify the most efficacious way to prevent renal transplant
recipients from CMV disease and to find out, if one of these two strategies may increase
graft or patient survival. Therefore, both wellknown approaches of CMV prevention were
compared in two study groups:
Prophylaxis (Group A): Oral primary prophylaxis with ganciclovir capsules was started
directly after transplantation and performed until day 90. In case of CMV infection (proven
CMV viral load) or symptomatic CMV disease, treatment with ganciclovir IV was initiated.
Preemptive Therapy (Group B): No oral primary prophylaxis was given. Treatment with
ganciclovir IV was given to patients with proven CMV viral load (CMV infection or CMV
disease) only.