StudyFinder
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
RECRUITING
18 years and over
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.
• 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.
DRUG: Letermovir 480 mg once daily, OTHER: Historical/Control
Kidney Transplant, Complications, CMV
Idris Yakubu, PharmD - idris.yakubu@vcuhealth.org
PHASE3
NCT06001320