End-Stage Kidney Disease (ESKD)Phase 1NCT07101055
Pharmacokinetics of Oral Letermovir in Adults With End-Stage Kidney Disease With or Without Haemodialysis
A Phase 1 study testing Letermovir 480 mg [PREVYMIS] in people with End-Stage Kidney Disease (ESKD), run by Jason A Roberts.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End-Stage Kidney Disease (ESKD)
- What is being tested?
- Letermovir 480 mg [PREVYMIS]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 proton pump inhibitors (omeprazole, pantoprazole).
- Patients who are taking any of the following medications: cyclosporine, pimozide, ergot alkaloids, or drug metabolism inducers including amiodarone, nafcillin, warfarin, carbamazepine, phenobarbital, phenytoin, glyburide, voriconazole, rifabutin, rifampicin, pimozide, thioridazine, bosentan, St. John's Wort, efavirenz, etravirine, nevirapine, sirolimus, tacrolimus, modafinil, CYP2C8 substrates (e.g., repaglinide, rosiglitazone), or CYP3A substrates (e.g., alfentanil, fentanyl, midazolam, quinidine).
- Patients with severe hepatic impairment.
- Pregnant, planning to conceive, breastfeeding, or intending to breastfeed during the study period.
- Presence of any rapidly progressing disease or immediately life-threatening illness (i.e., death deemed imminent within 48 hours).
- Any condition or circumstance that, in the investigator's opinion, would compromise patient safety or the integrity of study data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-Label, Single-Centre, Comparative Pharmacokinetic Study of Oral Letermovir (PREVYMIS) in Patients (i) Undergoing Intermittent Haemodialysis and (ii) Not Undergoing Intermittent Haemodialysis
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.
Read more
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.
- Conditions
- End-Stage Kidney Disease (ESKD)
- Being tested
- Letermovir 480 mg [PREVYMIS]
- Keywords
- pharmacokinetics, letermovir, intermittent haemodialysis, renal impairment, chronic kidney failure
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letermovir 480 mg [PREVYMIS]Drug
A single 480 mg oral dose of letermovir (2 x 240 mg tablets).
| Study group | Role | What they receive |
|---|---|---|
| ESKD undergoing intermittent haemodialysis | Experimental | Participants with end-stage kidney disease (ESKD) who are receiving regular intermittent haemodialysis. Each participant receives a single oral dose of letermovir (480 mg) approximately 2 hours before their scheduled dialysis session. Receives: Drug: Letermovir 480 mg [PREVYMIS] |
| ESKD not undergoing intermittent haemodialysis | Experimental | Participants with end-stage kidney disease (ESKD) who are not receiving haemodialysis. Each participant receives a single oral dose of letermovir (480 mg). Receives: Drug: Letermovir 480 mg [PREVYMIS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the plasma concentration-time Curve (AUC) of letermovir
The AUC will be calculated using non-compartmental analysis based on serial plasma concentration measurements following a single oral dose of letermovir. The aim is to compare systemic exposure between participants with end-stage kidney disease who are undergoing intermittent haemodialysis and those who are not.
Measured: Pre-dose to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are enrolled into two parallel groups based on dialysis status: adults with end-stage kidney disease (i) undergoing intermittent haemodialysis, and (ii) not undergoing dialysis. Each participant receives a single oral dose of letermovir (480 mg), and pharmacokinetic profiles are compared between groups. There is no randomisation or crossover.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason A Roberts
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Royal Brisbane and Women's Hospital
- Responsible party
- Sponsor-investigator, Jason A Roberts, The University of Queensland
- Investigators
- Jason A Roberts, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101055
- Sponsor's protocol ID
- UQ117254-Letermovir
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the small sample size and the potential for re-identification of participants with end-stage kidney disease, a vulnerable population. In addition, IPD sharing is not covered under the current ethics approval or participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Centre, Comparative Pharmacokinetic Study of Oral Letermovir (PREVYMIS) in Patients (i) Undergoing Intermittent Haemodialysis and (ii) Not Undergoing Intermittent Haemodialysis
- ClinicalTrials.gov ID
- NCT07101055
- Acronym / sponsor ID
- UQ117254-Letermovir
- Conditions
- End-Stage Kidney Disease (ESKD)
- Keywords
- pharmacokinetics, letermovir, intermittent haemodialysis, renal impairment, chronic kidney failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jason A RobertsUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Royal Brisbane and Women's Hospital
- Study start
- Sep 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are enrolled into two parallel groups based on dialysis status: adults with end-stage kidney disease (i) undergoing intermittent haemodialysis, and (ii) not undergoing dialysis. Each participant receives a single oral dose of letermovir (480 mg), and pharmacokinetic profiles are compared between groups. There is no randomisation or crossover.
| Arm | Type | Receives |
|---|---|---|
| ESKD undergoing intermittent haemodialysis | Experimental | Drug: Letermovir 480 mg [PREVYMIS]Participants with end-stage kidney disease (ESKD) who are receiving regular intermittent haemodialysis. Each participant receives a single oral dose of letermovir (480 mg) approximately 2 hours before their scheduled dialysis session. |
| ESKD not undergoing intermittent haemodialysis | Experimental | Drug: Letermovir 480 mg [PREVYMIS]Participants with end-stage kidney disease (ESKD) who are not receiving haemodialysis. Each participant receives a single oral dose of letermovir (480 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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 proton pump inhibitors (omeprazole, pantoprazole).
- Patients who are taking any of the following medications: cyclosporine, pimozide, ergot alkaloids, or drug metabolism inducers including amiodarone, nafcillin, warfarin, carbamazepine, phenobarbital, phenytoin, glyburide, voriconazole, rifabutin, rifampicin, pimozide, thioridazine, bosentan, St. John's Wort, efavirenz, etravirine, nevirapine, sirolimus, tacrolimus, modafinil, CYP2C8 substrates (e.g., repaglinide, rosiglitazone), or CYP3A substrates (e.g., alfentanil, fentanyl, midazolam, quinidine).
- Patients with severe hepatic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letermovir 480 mg [PREVYMIS]A single 480 mg oral dose of letermovir (2 x 240 mg tablets). | Drug | ESKD not undergoing intermittent haemodialysis, ESKD undergoing intermittent haemodialysis |
Primary outcome
Area Under the plasma concentration-time Curve (AUC) of letermovir
Time frame: Pre-dose to 48 hours post-dose
The AUC will be calculated using non-compartmental analysis based on serial plasma concentration measurements following a single oral dose of letermovir. The aim is to compare systemic exposure between participants with end-stage kidney disease who are undergoing intermittent haemodialysis and those who are not.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the small sample size and the potential for re-identification of participants with end-stage kidney disease, a vulnerable population. In addition, IPD sharing is not covered under the current ethics approval or participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason A Roberts, PhD principal investigator
The University of Queensland
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Letermovir 480 mg [PREVYMIS] in people with End-Stage Kidney Disease (ESKD), run by Jason A Roberts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Patricia Hernández Mitre, PhD (+617 3346 5555, p.mitre@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the plasma concentration-time Curve (AUC) of letermovir (time frame: Pre-dose to 48 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.