An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Wisconsin
UW Hospital and Clinics
RECRUITING
Madison
Contact Information
Primary
Sandesh Parajuli, MBBS
sparajuli@medicine.wisc.edu
(608) 262-2122
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2026-09
Participants
Target number of participants: 90
Treatments
Experimental: Letermovir for CMV in Transplant Patients
Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: University of Wisconsin, Madison