A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)

Conditions

• Cytomegalovirus Prophylaxis

Eligibility Criteria

Sex

ALL

Age

N/A - 17 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

First listed

Sep 30, 2025

Start date

Mar 30, 2026

Status verified

Sep 2026

Primary completion

Apr 14, 2028

Completion

May 19, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Weight-banded letermovir dosing
  Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days.

Primary Outcome Measure

Area Under the Curve From Time 0 to 24 Hours (AUC0-24) [ Time Frame: Day 7: Predose and at designated timepoints post-dose (up to 24 hours) ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (21)

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