A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms
Merck Sharp & Dohme LLC
40 participants
Apr 24, 2026
INTERVENTIONAL
Conditions
Summary
Researchers are looking for a way to prevent cytomegalovirus (CMV) in children and adolescents who receive a kidney transplant (KT) and weigh less than 40 kilograms (88.2 pounds). The goals of the study are to: * Learn what happens to letermovir in the body over time * Learn about the safety of letermovir and if participants tolerate it
Eligibility
Inclusion Criteria7
- Is a recipient of a primary or secondary allograft kidney
- Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care
- Has stable kidney function posttransplant
- Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment
- Must be able to take (as assessed by the investigator) letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube (oral pellets only)
- Does not have a condition that may interfere with the absorption of oral medication (e.g., vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the intensive pharmacokinetics (IPK) sampling is completed
- Weighs ≥2.5 and \<40 kg at enrollment (Day 1)
Exclusion Criteria8
- Has CMV disease or suspected CMV disease between screening and enrollment
- Is on dialysis or plasmapheresis at the time of enrollment
- Has evidence of CMV viremia at any time from screening until the time of enrollment
- Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment
- Is a multi-organ transplant recipient (e.g., kidney-pancreas)
- Has any uncontrolled infection on the day of enrollment
- Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment
- Has received or is receiving protocol-specified prohibited medications
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Interventions
Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07199465