5489W-13: Astellas CMV

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

Type of Study
Kidney/Dialysis - Kidney Transplant
Transplant Program
Short Description
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.
Principal Investigator
Lisa Florence, M.D.
Eligibility Notes
  • 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
Contact Name
Julie Wallick
(206) 215-3986