A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients
Sponsor: |
Merck Sharpe & Dohme Corp. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR7454 |
U.S. Govt. ID: |
NCT03443869 |
Contact: |
Marcus Pereira, MD, MPH: 212-305-0914 / mp2323@cumc.columbia.edu |
The MK-8228-002 Study is studying the safety and effectiveness of an investigational medication for preventing cytomegalovirus (CMV) disease in adults with kidney transplants. The MK-8228-002 Study is evaluating an investigational medication (known as MK-8228) versus valganciclovir (VGCV). VGCV is an antiviral medication and is the current standard of care for CMV disease prevention in kidney transplant recipients. The study will last for approximately one year (52 weeks). Study treatment will start within seven days post-transplant and continue through 28 weeks. In total, subjects will be monitored for CMV disease for approximately a year after transplant.
This study is closed
Investigator
Marcus Pereira, MD, MPH
Have you been told you tested positive for cytomegalovirus (CMV)? |
Yes |
No |
Will you receive a kidney transplant soon? |
Yes |
No |
Are you a multi-organ transplant recipient? |
Yes |
No |
Are you on dialysis? |
Yes |
No |
Are you pregnant or are you expecting to donate eggs or sperm? |
Yes |
No |