Actively Recruiting
An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
Led by University of Wisconsin, Madison · Updated on 2025-10-08
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of letermovir in preventing the return of cytomegalovirus (CMV) infection in adult patients who have received a kidney or simultaneous kidney/pancreas transplant and are considered high-risk due to their CMV serostatus. The trial focuses on those who develop CMV viremia requiring treatment and who demonstrate a lack of cell-mediated immunity. This Phase 3 interventional study aims to assess letermovir as a secondary prophylactic treatment after initial CMV infection therapy. Participants will switch from treatment with ganciclovir derivatives to letermovir, taking a 480 mg tablet orally once daily for 84 days. The conversion to letermovir will occur when viral load drops below 500 IU/mL, differing from the standard care which requires undetectable levels for two consecutive weeks before switching. This earlier switch aims to reduce exposure to valganciclovir and its potential side effects while supporting immune recovery. During the study, participants will be monitored weekly with viral load tests and assessed using a T-cell immunity test at the start and completion of letermovir treatment. Researchers will track the number of CMV replication episodes exceeding 1000 IU/mL within 90 days after stopping prophylaxis, and the duration of valganciclovir therapy. The study lasts about six months, with safety and immune response closely followed throughout the participation period.
CONDITIONS
Brief Title
Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have undergone kidney or simultaneous kidney/pancreas transplant
- Have high-risk CMV serostatus (D+/R-) at time of transplant
- Develop CMV viremia requiring treatment per institutional protocol
- Demonstrate proven or presumptive lack of cell-mediated immunity
- Able to provide informed consent to participate
You will not qualify if you...
- Contraindication to letermovir or its excipients
- Develop ganciclovir-resistant CMV infection
- Currently participating in any study involving CMV vaccine or investigational CMV agent
- Unable or unwilling to comply with the protocol
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 84 days
Participants receive letermovir 480 mg orally once daily as secondary prophylaxis after treatment of CMV infection.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
UW Hospital and Clinics
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
S
Sandesh Parajuli, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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