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
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/19/2018 |
| Start Date: | September 2015 |
| End Date: | January 30, 2016 |
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 Recipient
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
cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV
seronegative pretransplant and received a kidney from a CMV seropositive donor
Inclusion Criteria:
- CMV seronegative recipient who received a kidney from a CMV seropositive donor
- First or second kidney transplant recipient
- Within 14 days post transplant, eGFR > 10 mL/min by the C-G equation
- Able to ingest tablets
Exclusion Criteria:
- Multiorgan transplant recipient
- Plasma CMV PCR >LOD by the central lab
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Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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