Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06001320
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06001320
Study Brief:
Protocol Section:
NCT06001320