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

Recruiting now · Phase 1

Conditions studied: Cytomegalovirus Prophylaxis

In brief

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 facts

Study ID

NCT07199465

Run by

Merck Sharp & Dohme LLC

People needed

40

Starts

2026-03-30

Expected to finish

2028-05-19

Last updated by the study team

2026-07-13

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The main inclusion criteria include but are not limited to the following:
• 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)

You may not qualify if…

• The main exclusion criteria include but are not limited to the following:
• 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

Where it is running

• University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019) — Birmingham, Alabama, United States (enrolling)
• UCLA Clinical & Translational Research Center (CTRC) ( Site 0006) — Los Angeles, California, United States (enrolling)
• Lucile Packard Children's Hospital ( Site 0001) — Palo Alto, California, United States (enrolling)
• University of California Davis Health ( Site 0023) — Sacramento, California, United States (enrolling)
• UCSF Medical Center at Mission Bay ( Site 0017) — San Francisco, California, United States (enrolling)
• Children's Hospital Colorado ( Site 0013) — Aurora, Colorado, United States (enrolling)
• University of Miami School of Medicine ( Site 0021) — Miami, Florida, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004) — Chicago, Illinois, United States (enrolling)
• University of Michigan ( Site 0014) — Ann Arbor, Michigan, United States (enrolling)
• M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007) — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic - Rochester ( Site 0015) — Rochester, Minnesota, United States (enrolling)
• Morgan Stanley Children's Hospital ( Site 0018) — New York, New York, United States (enrolling)
• Montefiore Einstein Center ( Site 0024) — The Bronx, New York, United States (enrolling)
• Levine Children's Hospital ( Site 0022) — Charlotte, North Carolina, United States (enrolling)
• Duke University-Pediatrics ( Site 0008) — Durham, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital Medical Center ( Site 0002) — Cincinnati, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia (CHOP) ( Site 0003) — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Children's Hospital ( Site 0005) — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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