Conditions: Cytomegalovirus Disease
Keywords: kidney transplant allograft recipients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

Brief summary:
To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor

Detailed description:
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral BCV versus vGCV for the prevention of CMV disease in high-risk kidney transplant allograft recipients, defined as CMV-seronegative recipients (R-) receiving a CMV-seropositive graft (D+). The study comprised a screening evaluation period (up to 14 days posttransplant), a treatment period (up to 28 weeks posttransplant), and a posttreatment follow-up period (24 weeks, through Week 52 posttransplant).

Arms:
arm 1: 100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily. arm 2: 900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.

Interventions: intervention 1: Brincidofovir intervention 2: Valganciclovir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: