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Recruiting Phase 3 NCT06407232

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

Trial Parameters

Condition Cytomegalovirus Infections
Sponsor University of Wisconsin, Madison
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-08
Completion 2026-09
Interventions
Letermovir

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.

Eligibility Criteria

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

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