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Completed NCT06001320

De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

Conditions: Kidney Transplant; Complications, CMV

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 30
Sponsor: Virginia Commonwealth University

Location: VCU Medical Center Richmond Virginia

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.

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06001320). StuddyBuddy aggregates publicly available trial information.