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

RecruitingPhase 3

Sponsor: University of Wisconsin, Madison

Conditions: Cytomegalovirus Infections, Kidney Transplant Infection, Pancreas Transplant

Interventions: Letermovir

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Madison, Wisconsin, United States