De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

CMV viremia will be treated with either oral valganciclovir, intravenous ganciclovir or alternative agents, according to AST ID COP (American Society of Transplantation Infectious disease community of practice) guidelines.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Letermovir

Criteria

Historical Control group:

Inclusion Criteria

1. Kidney transplant recipients

2. Male or female age ≥ 18 years old

3. African American race

4. CMV high risk (D+/R-)

5. received valganciclovir for CMV prophylaxis

Historical Control group:

Exclusion

1. Re-transplantation

2. Panel of reactive antibody ≥80% at the time of transplant

3. Positive cytotoxic cross match at the time of transplant

Experimental Group Inclusion Criteria

1. Kidney transplant recipients

2. Male or female age ≥ 18 years old

3. African American race

4. CMV high risk (D+/R-)

5. Ability to provide informed consent before any trial related activities

Exclusion Criteria

1. Re-transplantation

2. Panel of reactive antibody ≥80% at the time of transplant

3. Positive cytotoxic cross match at the time of transplant

4. Pregnancy and Breastfeeding

5. Prisoners

6. Patients with hypersensitivity to acyclovir, valacyclovir or any of its components

7. Patients with hypersensitivity to Letermovir or any of its components

8. 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.