Phase 4
N=70
Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
Transplant Complication · CMV
Bottom Line
View on ClinicalTrials.gov: NCT06034925 ↗Enrolled (actual)
70
Serious AEs
4.3%
Results posted
Apr 2026
Primary outcome: Primary: Clinical Significant Leukopenia — 8; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Maribavir (Drug); Valganciclovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Significant Leukopenia |
8; 1 | — |
| PRIMARY CMV Infection |
8; 11 | — |
Summary
The purpose of this study is to find out if there is a difference in how well the standard MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in preventing CMV infections in kidney transplant recipients who are at risk for this type of infection, while also assessing the tolerability of these two regimens. The two medication regimens being compared are Valganciclovir (FDA approved to prevent and treat CMV infection) vs Maribavir (FDA approved to treat CMV infection) plus Acyclovir (FDA approved to prevent HSV infection).
Eligibility Criteria
Inclusion Criteria
- Kidney transplant recipient at study institution
- =7 days of transplant
- Received at least one dose of rATG induction or patient is D+/R- CMV serostatus
Exclusion Criteria
- Age <18 years at time of transplant
- Recipient of pancreas, liver, heart, lung transplant
- Recipient of investigational, non-FDA approved medication
Data sourced from ClinicalTrials.gov (NCT06034925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.