NCT01974206

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants were followed for one year after first study drug injection. This was the primary study period. Participants were followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.

Conditions

• Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients

Interventions

Type	Name	Description
BIOLOGICAL	ASP0113	intramuscular injection
DRUG	Placebo	intramuscular injection

Timeline

• Start date: 2013-11-20
• Primary completion: 2016-05-13
• Completion: 2020-11-05
• First posted: 2013-11-01
• Last updated: 2024-10-24
• Results posted: 2022-01-04

Locations

53 sites across 6 countries: United States, Australia, Canada, France, Germany, Spain

Regulatory

• FDA-regulated drug study