Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Letermovir
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov