NCT07199465

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cytomegalovirus Prophylaxis

Interventions

Type	Name	Description
DRUG	Letermovir	Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.

Timeline

• Start date: 2026-03-30
• Primary completion: 2028-04-14
• Completion: 2028-05-19
• First posted: 2025-09-30
• Last updated: 2026-04-20

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study