Pharmacokinetics of Oral Letermovir in Adults With End-Stage Kidney Disease With or Without Haemo… (NCT07101055) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pharmacokinetics of Oral Letermovir in Adults With End-Stage Kidney Disease With or Without Haemodialysis
20 participantsStarted 2025-09
Plain-language summary
This study aims to understand how the antiviral medication letermovir (PREVYMIS) is processed by the body in adults with end-stage kidney disease (ESKD), including those who are receiving intermittent haemodialysis and those who are not. Letermovir is already approved in many countries, including Australia, for preventing cytomegalovirus (CMV) infections in patients who have received stem cell transplants. However, its pharmacokinetics - or how the drug is absorbed, distributed, and cleared from the body - have not been studied in patients with ESKD, especially those on dialysis.
This is a single-centre, open-label, interventional pharmacokinetic study. It will recruit 20 adult participants, split into two groups: 10 participants on intermittent haemodialysis and 10 not undergoing dialysis. All participants will receive a single oral dose of 480 mg letermovir. The study does not involve treatment for CMV infection. Instead, it focuses only on how the drug behaves in the body in this patient population.
Participants will have blood samples collected before and after taking the medication to measure drug concentrations over time. In patients on dialysis, an additional sample will be taken from the dialysis machine to understand if letermovir is removed during treatment. No more than 35 mL of blood (around two tablespoons) will be collected across two study visits.
The goal of this study is to generate important safety and dosing information to help guide future use of letermovir in people with kidney failure. It is expected that these findings will support more informed clinical decisions and potentially lead to updated dosing recommendations for this group.
The study is funded by Merck Sharp \& Dohme LLC (MSD), the manufacturer of letermovir, and is being conducted by researchers from The University of Queensland Centre for Clinical Research (UQCCR) and the Royal Brisbane and Women's Hospital (RBWH). To support participation, prepaid meal vouchers, taxi vouchers, or parking tickets will be provided so that participants do not incur any out-of-pocket expenses.
Participation is voluntary. The study has been approved by a Human Research Ethics Committee and is conducted according to national ethical guidelines.
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:
All participants of childbearing potential who are engaging in sexual activity that could result in pregnancy must be willing to use highly effective contraception from screening through 30 days post-dose of letermovir. Male participants must also agree not to donate sperm during this period.
Group 1:
* Adult participants (≥18 years old).
* Estimated Glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m2.
* Clinical indication for regular intermittent haemodialysis.
* Agreement to receive a single 480 mg dose of letermovir.
* Willing and able to provide informed consent.
* Consent to cannula placement for blood draws.
Group 2:
* Adult participants (≥18 years old).
* Estimated Glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m2.
* No clinical indication for regular intermittent haemodialysis.
* Agreement to receive a single 480 mg dose of letermovir.
* Willing and able to provide informed consent.
* Consent to cannula placement for blood draws.
Exclusion Criteria:
* Participants who lack the capacity to provide informed consent.
* Patients with suspected or known hypersensitivity to any of the active or inactive ingredients of the oral letermovir formulation.
* Patients who are taking any of the following medications, unless these can be safely discontinued temporarily for the duration of the study as determined by the study investigator: statins (pitavastatin, simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin) and prot…
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.
1Since this is a Phase 1 trial focused on how the body processes letermovir — not yet on whether it treats my condition — what does that mean for my personal safety if I were to consider participating?
2This trial is specifically studying letermovir in people with end-stage kidney disease who are on or off haemodialysis — given my current kidney situation and whether I'm on dialysis, would I even be a candidate worth discussing with the research team once it opens?
3The trial hasn't started recruiting yet, so how long might I realistically have to wait before I could even be considered, and does that timeline affect any treatment decisions I need to make now?
4Since the main thing being measured is how letermovir moves through the bloodstream in people with end-stage kidney disease, what would the researchers actually be asking me to do — like blood draws and monitoring visits — and how would that fit into my existing dialysis schedule?
5Are there already approved antiviral options that letermovir is related to that I could discuss as a current treatment path, rather than waiting for this early-stage pharmacokinetics study to open?
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.
What they're measuring
1
Area Under the plasma concentration-time Curve (AUC) of letermovir