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De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Sponsor: Virginia Commonwealth University
Summary
This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. There are two arms in the study: Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month. Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.
Official title: Historical Controlled, Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-09-25
Completion Date
2026-09-01
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Letermovir 480 mg once daily
We will test the study hypothesis in a single center, matched (1:1 fashion) pilot study of Letermovir 480 mg once daily versus historically matched AA kidney transplant recipients who received valganciclovir. We will enroll 30 AA patients over a 12-month period into the Letermovir group and compare outcomes to a historical group of 30 AA kidney transplant recipients who have received valganciclovir prophylaxis (1:1 fashion), for a total of 60 patients. We will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies.
Historical/Control
The control study group will include high-risk African American kidney transplant recipients cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group. This time frame is based upon the current volume of transplants done at VCU. On average 30 liver and/or kidney transplants are done per month. Thus, 5 years should be an adequate time frame to mine enough number of participants to answer our primary research hypothesis.
Locations (1)
VCU Medical Center
Richmond, Virginia, United States