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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients ASP0113 Cytomegalovirus (CMV) Kidney Transplantation

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Site US10036
    San Francisco, California, 94115, USA
  • Site US10003
    Los Angeles, California, 90057, USA
  • Site US10004
    San Diego, California, 92123, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT01974206
Phase
Phase 2
Lead Scientist
Flavio Vincenti
Study Type
Interventional
Last Updated
March 2017