A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients
Status:
Completed
Trial end date:
2014-10-15
Target enrollment:
Participant gender:
Summary
This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the
safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in
cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive
donor, with use of a preemptive approach for prevention of CMV disease. Participants will be
randomized into two treatment groups: active or placebo control; both arms will be followed
preemptively. The study has a planned enrollment of approximately 120 participants (60 active
and 60 placebo).