Overview

This trial is active, not recruiting.

Condition compare efficacy of bcv to vgcv for prevention of cmv disease in kidney transplant recipients who are cmv seropositive pretransplant
Treatments brincidofovir, valganciclovir
Phase phase 3
Sponsor Chimerix
Start date September 2015
End date January 2017
Trial size 520 participants
Trial identifier NCT02439957, CMX001-307

Summary

• To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and received antilymphocyte induction therapy

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Active Comparator)
BCV plus vGCV placebo
brincidofovir BCV CMX001
(Active Comparator)
vGCV plus BCV placebo
valganciclovir vGCV

Primary Outcomes

Measure
The incidence of CMV disease, which includes CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Wk 24 posttransplant.
time frame: 24 weeks

Secondary Outcomes

Measure
Proportion of subjects with eGFR ≤ 45 mL/min at Wk 24 as calculated by the CKD-EPI
time frame: 24 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - CMV seropositive (R+), who received antilymphocyte induction therapy with antithymocyte globulin (ATG) - First or second kidney transplant recipient - 14 days posttransplant eGFR > 10mL/min by the C-G equation - Able to ingest tablets Exclusion Criteria: - Multi organ transplant recipient - Plasma CMV PCR > LOD by the central lab

Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Chimerix.