Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

NCT06034925 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00125967
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Transplant Complication; CMV

Outcome Measures

Primary Outcomes (2)

• Clinical Significant Leukopenia

  Compare the proportion of patients that develop leukopenia in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection. Clinically significant leukopenia is defined as a white blood cell count that is \<3,000 cells/mm3 with an adjustment in either mycophenolate or the antiviral prophylaxis.

  One year following transplant

• CMV Infection

  CMV infection is defined as having at least one CMV DNA PCR test of \>1000 copies/mL. Compare the proportion of patients that develop cytomegalovirus (CMV) infection in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.

  One year following transplant

Study Arms (2)

Control

ACTIVE COMPARATOR

valganciclovir 900mg once daily

Drug: Valganciclovir

Intervention

EXPERIMENTAL

maribavir 400mg twice daily

Drug: Maribavir

Interventions

Maribavir DRUG

maribavir 400mg twice daily

Intervention

Valganciclovir DRUG

valganciclovir 900mg once daily

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years at time of transplant
• Recipient of pancreas, liver, heart, lung transplant
• Recipient of investigational, non-FDA approved medication

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Takeda: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Culpepper H, Overstreet M, Soliman K, Casey M, Rice T, Lively K, Scalea J, McGillicuddy J, Patel N, Taber D. A Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for Cytomegalovirus (CMV) Prophylaxis in High-Risk Kidney Transplant Recipients: Study Protocol. Cureus. 2025 Aug 27;17(8):e91110. doi: 10.7759/cureus.91110. eCollection 2025 Aug.

  PMID: 41018408 DERIVED

MeSH Terms

Interventions

maribavir; Valganciclovir

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

None noted with analysis.

Results Point of Contact

• Title: Professor
• Organization: Medical University of South Carolina

taberd@musc.edu

8437922724

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: November 6, 2023
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Locations

US (1)