Recruiting
Phase 3

Letermovir

Sponsor:

University of Wisconsin, Madison

Code:

NCT06407232

Conditions

Cytomegalovirus Infections

Kidney Transplant Infection

Pancreas Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Letermovir

Study Details

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

Study ID

NCT06407232

Start date

Aug 8, 2024

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Letermovir for CMV in Transplant Patients

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

Interventions

Letermovir

480 mg taken orally once daily, for 84 days

Primary outcome measure

  • Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL [ Time Frame: up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study) ]
  • Duration of valganciclovir (VGC) Treatment [ Time Frame: up to 2 months ]

Central Contacts and Locations

Central contacts

Sandesh Parajuli, MBBS

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

Locations

UW Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-11.