A Study 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

  • Interventional
  • Recruiting
  • NCT01974206
Eligibility Details Visit Clinicaltrials.gov

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.

Subjects will be followed for one year after first study drug injection. This is the primary study period.

     Subjects will be followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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.

        Exclusion Criteria:

         - Subject is planned to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.

         - Subject has received from one month prior to transplant or is planning to receive CMV immunoglobulin.

         - Subject has had CMV viremia or CMV disease from time of transplant until time of Randomization.

At a Glance

National Government IDNCT01974206

IRB#IRB14-0016

Lead SponsorAstellas Pharma Global Development, Inc.

Lead PhysicianPiotr P. Witkowski

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting