Clinical trial NCT07101055: Pharmacokinetics of Oral Letermovir in Adults With End-Stage Kidney Disease With or Without Haemodialysis
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
Conditions: End-Stage Kidney Disease (ESKD)
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.
Interventions:
description: A single 480 mg oral dose of letermovir (2 x 240 mg tablets).
name: Letermovir 480 mg [PREVYMIS]
type: Drug
Study arms:
design_group_description: 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.
design_group_title: ESKD undergoing intermittent haemodialysis
design_group_type: Experimental
design_group_description: Participants with end-stage kidney disease (ESKD) who are not receiving haemodialysis. Each participant receives a single oral dose of letermovir (480 mg).
design_group_title: ESKD not undergoing intermittent haemodialysis
design_group_type: Experimental
Sponsor: The University of Queensland
Collaborators: Merck Sharp & Dohme LLC
Royal Brisbane & WomenS Hospital
Drug name mappings:
name: 来特莫韦
lang: CN
name: Letermovir
lang: EN
name: レテルモビル
lang: JP