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

Virginia Commonwealth University (VCU)

Status and phase: Enrolling; Early Phase 1

Conditions: Kidney Transplant; Complications; CMV

Treatments: Other: Historical/Control; Drug: Letermovir 480 mg once daily

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06001320

HM20027540

Details and patient eligibility

About

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.

Full description

Intervention: Letermovir prophylaxis. Prophylaxis is once daily dose of Letermovier starting Day 1 of post-transplant up until 6 months post-transplant.

Participants enrolled in this study will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment.

Strategy for CMV Viremia: 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Letermovir group (study group)

Experimental group

Description:

Letermovir 480 mg once daily

Treatment:

Drug: Letermovir 480 mg once daily

Historically matched AA kidney transplant recipients who received valganciclovir

Other group

Description:

Compare outcomes to a historical group of 50 AA kidney transplant recipients who have received valganciclovir prophylaxis

Treatment:

Other: Historical/Control