A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus

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.
• ✓. 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.