Letermovir vs Valganciclovir in CMV R+ Kidney Transplant (NCT07571135) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Letermovir vs Valganciclovir in CMV R+ Kidney Transplant
United States300 participantsStarted 2026-05
Plain-language summary
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.
The main question the study wants to answer is:
• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?
The study will also look at other important questions:
* Is letermovir easier for patients to tolerate than valganciclovir?
* How long does it take for a CMV infection to appear in each group?
* Are there differences in "breakthrough" CMV infections between the two medications?
* For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (both arms):
* ≥18 years old
* Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant
Inclusion Criteria (letermovir arm):
* Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation
* Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation
Exclusion Criteria (both arms):
* Multiorgan organ transplant
* Received previous solid organ transplant or HSCT
* Unable to take oral medications
* Uncontrolled infections at the time of enrollment
* Hemodynamically unstable or on mechanical ventilation at the time of enrollment
* Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor
* Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation
* Received any anti-CMV drug treatment within 7 days prior to enrollment
* Current user of recreational or illicit drugs or alcohol dependence
* History of CMV disease prior to enrollment
Exclusion Criteria (letermovir arm):
* Previously participated in a letermovir study or any other study with CMV investigational agents
* On dialysis or plasmapheresis at the time of enrollment
* Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations
* Child-Pugh Class C severe hepatic insufficiency
* Currently participating …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.