RecruitingPhase 3NCT06407232

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

An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients


Sponsor

University of Wisconsin, Madison

Enrollment

90 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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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Interventions

DRUGLetermovir

480 mg taken orally once daily, for 84 days


Locations(1)

UW Hospital and Clinics

Madison, Wisconsin, United States

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NCT06407232


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