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

Completed · Phase 2 · Has a placebo group

Conditions studied: Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients

In brief

The purpose of this study was 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 also evaluated the safety of ASP0113 in this patient population.

Key facts

Study ID

NCT01974206

Run by

Astellas Pharma Global Development, Inc.

People needed

150

Starts

2013-11-20

Expected to finish

2020-11-05

Last updated by the study team

2024-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CMV negative subject having received a CMV seropositive kidney (living or deceased)
• Participant started valganciclovir or ganciclovir within 10 days of transplant and had received it through Randomization.

You may not qualify if…

• Participant underwent a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
• Participant had received from one month prior to transplant or planned to receive CMV immunoglobulin.
• Participant had CMV viremia or CMV disease from time of transplant until time of Randomization.

Where it is running

• Site US10003 — Los Angeles, California, United States
• Site US10004 — San Diego, California, United States
• Site US10036 — San Francisco, California, United States
• Site US10037 — San Francisco, California, United States
• Site US10044 — Aurora, Colorado, United States
• Site US10018 — New Haven, Connecticut, United States
• Site US10058 — Atlanta, Georgia, United States
• Site US10013 — Atlanta, Georgia, United States
• Site US10030 — Chicago, Illinois, United States
• Site US10009 — Chicago, Illinois, United States
• Site US10057 — Indianapolis, Indiana, United States
• Site US10046 — Lexington, Kentucky, United States
• Site US10041 — New Orleans, Louisiana, United States
• Site US10049 — Portland, Maine, United States
• Site US10023 — Ann Arbor, Michigan, United States
• Site US10048 — Detroit, Michigan, United States
• Site US10016 — St Louis, Missouri, United States
• Site US10015 — Omaha, Nebraska, United States
• Site US10045 — Buffalo, New York, United States
• Site US10012 — The Bronx, New York, United States
• Site US10050 — Greenville, North Carolina, United States
• Site US10001 — Cleveland, Ohio, United States
• Site US10042 — Pittsburgh, Pennsylvania, United States
• Site US10047 — Charleston, South Carolina, United States
• Site US10026 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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