SURPASS: A Randomized, Double-Blind, Multicenter Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus (CMV) Disease in CMV Seropositive Kidney Transplant Recipients (BCV CMV vGCV)
This trial has been terminated.
|Condition||compare efficacy of bcv to vgcv for prevention of cmv disease in kidney transplant recipients who are cmv seropositive pretransplant|
|Start date||September 2015|
|End date||May 2016|
|Trial size||520 participants|
|Trial identifier||NCT02439957, CMX001-307|
• 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|
|Intervention model||parallel assignment|
|Masking||participant, care provider, investigator|
BCV plus vGCV placebo
vGCV plus BCV placebo
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
Proportion of subjects with eGFR ≤ 45 mL/min at Wk 24 as calculated by the CKD-EPI
time frame: 24 Weeks
All 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
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