Clinical Trial: SUSTAIN: A Randomized, Double-Blind, Multicenter, Phase 3 Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease in CMV Seronegative Kidney Allograft Recipients
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: SUSTAIN: A Randomized, Double-Blind, Multicenter, Phase 3 Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalov
Brief Summary: To compare the efficacy of 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 Summary:
Sponsor: Chimerix
Current Primary Outcome: The incidence of CMV disease, which includes CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and week 52 [ Time Frame: 52 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Proportion of subjects with estimated glomerular filtration rate (eGFR) </=45 mL/min at wk 52 as calculated by the CKD-EPI [ Time Frame: 52 weeks ]
Original Secondary Outcome: Same as current
Information By: Chimerix
Dates:
Date Received: May 7, 2015
Date Started: September 2015
Date Completion: September 2018
Last Updated: January 5, 2017
Last Verified: January 2017