Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients

NCT06407232 | Recruiting Phase 3 FDA Drug

• 4 other identifiers: 2024-0174A561000Protocol Version 8/22/25235208
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney/pancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.

Conditions

Cytomegalovirus Infections; Kidney Transplant Infection; Pancreas Transplant

Outcome Measures

Primary Outcomes (2)

• Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL

  To test the hypothesis that letermovir will be associated with reduced incidence of recurrent viremia, recurrence will be measured defined as incidence of any cytomegalovirus replication greater than 1000 IU/mL requiring treatment after withdrawal of secondary prophylaxis.

  up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study)

• Duration of valganciclovir (VGC) Treatment

  To test the hypothesis that letermovir will be associated with reduced duration of (val)ganciclovir treatment, the duration of VGC treatment will be measured.

  up to 2 months

Secondary Outcomes (1)

• Number of Participants with Positive Result for T-Cell Immunity Panel (TCIP) Testing

  letermovir initiation (Day 0), at secondary prophylaxis completion (Week 12 +/- 28 days)

Study Arms (1)

Letermovir for CMV in Transplant Patients

EXPERIMENTAL

Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir

Drug: Letermovir

Interventions

Letermovir DRUG

480 mg taken orally once daily, for 84 days

Also known as: Prevymis

Letermovir for CMV in Transplant Patients

Eligibility Criteria

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

You may qualify if:

• undergone kidney or simultaneous kidney/pancreas transplant
• high-risk CMV serostatus (D+/R-) at time of transplant
• develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in the CMV stewardship monitoring initiative)
• demonstrate proven or presumptive lack of CMI, either by CMI testing or risk factor screening
• able to provide informed consent to participate

You may not qualify if:

• contraindication to letermovir or its excipients
• develop ganciclovir-resistant CMV infection
• currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent
• unable or unwilling, in the opinion of the Investigator, to comply with the protocol
• pregnant or breastfeeding

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Sandesh Parajuli, MBBS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandesh Parajuli, MBBS

CONTACT

(608) 262-2122; sparajuli@medicine.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)