Conditions: Cytomegalovirus Disease Kidney Transplant Infection
Keywords: Cytomegalovirus CMV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy.

Detailed description:
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy. The study comprised a screening evaluation period (up to 14 days posttransplant), a treatment period (up to 14 weeks posttransplant), and a posttreatment follow-up period (10 weeks, through Week 24 posttransplant).

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

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

Protocol document: