A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.
January 01, 1900
Kidney/Dialysis - Kidney Transplant
Lisa Florence, M.D.
- CMV negative subject having received a CMV seropositive kidney (living or deceased)
- Subject started valganciclovir or ganciclovir within 10 days of transplant and has received it through randomization
- No plans to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days
- Must not have had CMV viremia or CMV disease from time of transplant until time of randomization