De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney T… (NCT06001320) | Clinical Trial Compass
Active — Not RecruitingPhase 3
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
United States30 participantsStarted 2023-09-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Kidney transplant recipients
✓. Male or female age ≥ 18 years old
✓. African American race
✓. CMV high risk (D+/R-)
✓. received valganciclovir for CMV prophylaxis
Exclusion criteria
✕. Re-transplantation
✕. Panel of reactive antibody ≥80% at the time of transplant
✕. Positive cytotoxic cross match at the time of transplant
✕. Kidney transplant recipients
✕. Male or female age ≥ 18 years old
✕. African American race
✕. CMV high risk (D+/R-)
What they're measuring
1
Incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients