Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: 1-Year Results of a Randomized Clinical Trial.
Witzke O, Hauser I A, et al.Transplantation 93(1):61-8, 2012.
Aims
To determine whether renal transplant recipients with a positive cytomegalovirus (CMV) serostatus had a higher rate of CMV infection and disease after transplantation when treated preemptively compared with primary valganciclovir prophylaxis.
Interventions
Prophylaxis (oral valganciclovir/day for 100 days) versus preempty therapy.
Participants
297 kidney transplant recipients.
Outcomes
Primary efficacy outcomes were the proportion of patients with CMV infection/disease within 12 months. Secondary efficacy variables were the proportion of patients with CMV syndrome or disease, time to occurrence of first viremia, viral burden at viremia, creatinine clearance at month 12, and the proportion of patients with treated and biopsy-proven acute rejection episodes within 12 months. The incidence of serious adverse events, the proportion of patients with opportunistic infections, posttransplant diabetes mellitus within 12 months, and patient and graft survival were also monitored.
Follow-up
12 months
CET Conclusions
Prophylaxis with oral valgancicolvir significantly reduced the incidence of CMV infection and disease in comparison with the pre-emptive use of valgancicolvir based on monitoring by CMV-polymerised chain reaction.
Data analysis
Modified intention-to-treat analysis
Trial registration
NCT00372229 (ClinicalTrials.gov)