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

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Aug 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different medications, Letermovir and Valganciclovir, to prevent a virus called cytomegalovirus (CMV) in African American patients who have received a kidney transplant. CMV can be a serious complication after a transplant, especially for those considered at high risk. The trial aims to compare how well these two medications work in preventing CMV infections in kidney transplant recipients.

To participate in this trial, individuals need to be at least 18 years old, identify as African American, and be at high risk for CMV (defined as D+/R-). They should not have had a kidney transplant before, nor can they have certain medical conditions or be pregnant. Those who join the study will receive either Letermovir or Valganciclovir, and their health will be monitored closely to see how well the treatment works. It's important for potential participants to discuss any current medications with their doctors to ensure they can safely join the trial.

Gender

ALL

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.