Comparing Letermovir and Valganciclovir for Preventing CMV in Kidney Transplant Recipients

Historical Controlled, Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

This study is testing whether Letermovir works better than Valganciclovir to prevent CMV infections in African American kidney transplant recipients during their first year after surgery.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Virginia Commonwealth University (other)
• Locations: 1 site (Richmond, Virginia)
• Trial ID: NCT06001320 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of Letermovir versus Valganciclovir in preventing cytomegalovirus (CMV) infections in African American kidney transplant recipients during the first year post-transplant. It includes two groups: one receiving Letermovir prophylaxis and another that has completed a course of Valganciclovir. The study aims to assess not only the prevention of CMV viremia but also the incidence of leukopenia and acute rejection rates. Participants will be monitored for various outcomes related to CMV and overall transplant health.

Who should consider this trial

Good fit: Ideal candidates are African American adults aged 18 and older who are kidney transplant recipients at high risk for CMV.

Not a fit: Patients who are not African American, those under 18, or individuals with a history of re-transplantation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective prophylactic treatment option for preventing CMV infections in high-risk kidney transplant recipients.

How similar studies have performed: Other studies have shown promise in using Letermovir for CMV prophylaxis, indicating potential for success in this approach.

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.

Where this trial is running

Richmond, Virginia

• VCU Medical Center — Richmond, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Gaurav Gupta, MD — Virginia Commonwealth University
• Study coordinator: Idris Yakubu, PharmD

Conditions: Kidney Transplant, Complications, CMV