Status:
ACTIVE_NOT_RECRUITING
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Kidney Transplant; Complications
CMV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ki...
Detailed Description
Valganciclovir (VGC) is the drug of choice for CMV prophylaxis. Although effective in preventing CMV infections, VGC is commonly associated with profound bone marrow suppression, specifically leukopen...
Eligibility Criteria
Inclusion
- Historical Control group:
- 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
- Historical Control group:
- Exclusion
- Re-transplantation
- Panel of reactive antibody ≥80% at the time of transplant
- Positive cytotoxic cross match at the time of transplant
- Experimental Group Inclusion Criteria
- Kidney transplant recipients
- Male or female age ≥ 18 years old
- African American race
- CMV high risk (D+/R-)
- Ability to provide informed consent before any trial related activities
- Exclusion Criteria
- Re-transplantation
- Panel of reactive antibody ≥80% at the time of transplant
- Positive cytotoxic cross match at the time of transplant
- Pregnancy and Breastfeeding
- Prisoners
- Patients with hypersensitivity to acyclovir, valacyclovir or any of its components
- Patients with hypersensitivity to Letermovir or any of its components
- If Patients are taking any of these medications: pimozide, ergot alkaloids (ergotamine, dihydroergotamine), or pitavastatin/simvastatin co-administered with cyclosporine, we will work with the prescribing physician to find an appropriate replacement therapy which will not interfere with any study-related interventions. Otherwise, participants will be excluded from the study.
Exclusion
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06001320
Start Date
September 25 2023
End Date
September 1 2026
Last Update
January 8 2026
Active Locations (1)
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1
VCU Medical Center
Richmond, Virginia, United States, 23219