A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus (NCT02439957) | Clinical Trial Compass
TerminatedPhase 3
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
Stopped: Study terminated early due to results from another CMX001 study.
United States6 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Were male or female kidney transplant recipients who were ≥18 years of age (subject to local law/practice for clinical trial participation) and ≤14 days following their first or second renal allograft.
. Were at high risk of cytomegalovirus (CMV) infection, which for the purposes of this study, was defined as CMV-seropositive recipients who received lymphocyte depleting induction treatment with antithymocyte globulin (Thymoglobulin® or Atgam®) prior to or during the qualifying transplant.
. Had an estimated glomerular filtration rate of \>10 mL/min (Cockcroft-Gault equation) at screening based on local laboratory results.
. Were CMV viremia negative (i.e., "not detected") as measured by the designated central virology laboratory using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test no more than 5 days prior to subject randomization, and at all prior assessments performed since transplant under local standard of care.
. Were able to ingest, absorb, and tolerate tablets.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If male, was willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 24.
. If female of childbearing potential, i.e., not postmenopausal or surgically sterile, was willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 24.
. Were willing and able to provide informed consent.
Exclusion criteria
. Weighed ≤50 kg (110 lbs) or ≥120 kg (265 lbs).
. Were pregnant or breastfeeding or intended to conceive during the study period (i.e., through Week 24).
. Received a stem cell transplant or solid organ transplant other than a kidney transplant.
. Had suspected CMV disease (either syndrome or tissue-invasive disease) or detectable CMV viremia by the central virology laboratory prior to the first dose of study drug.
. Had a history of CMV disease (either syndrome or tissue-invasive disease) within 6 months prior to the first dose of study drug.
. Had an absolute neutrophil count of \< 500 cells/μL, platelet count of \< 25,000 platelets/μL, or hemoglobin of \< 8 g/dL at screening.
. Had hypersensitivity (not including renal dysfunction or an eye disorder) to valganciclovir (vGCV), ganciclovir (GCV), cidofovir (CDV), or brincidofovir (BCV) or their excipients.
. Had received (or who are anticipated to need treatment with) any of the following: