A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
NCT ID: NCT07199465
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2026-02-27
2028-05-19
Brief Summary
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* Learn what happens to letermovir in the body over time
* Learn about the safety of letermovir and if participants tolerate it
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Weight-banded letermovir dosing
Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days.
Letermovir
Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Interventions
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Letermovir
Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Lucile Packard Children's Hospital ( Site 0001)
Palo Alto, California, United States
University of Michigan ( Site 0014)
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester ( Site 0015)
Rochester, Minnesota, United States
Morgan Stanley Children's Hospital ( Site 0018)
New York, New York, United States
Duke University Medical Center ( Site 0008)
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8228-077
Identifier Type: OTHER
Identifier Source: secondary_id
8228-077
Identifier Type: -
Identifier Source: org_study_id
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