At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open, Randomised Study Comparing Preemptive Therapy With Intravenous Ganciclovir With and Without Additional Oral Ganciclovir for CMV Prophylaxis in Immunosuppressed Renal Transplant Patients Receiving Monitoring of CMV Viral Load
In Brief
A Phase 4 clinical trial evaluating Ganciclovir for DNA Virus Infection and 2 related conditions. Completed.
Detailed 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.