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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07199465

Registry updated: 2026-10-13
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Description

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

Interventions

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

Eligibility criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Conditions

Cytomegalovirus Prophylaxis

Locations

  • University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019) — Birmingham, Alabama, United States
  • Children's Hospital Los Angeles ( Site 0016) — Los Angeles, California, United States
  • UCLA Clinical & Translational Research Center (CTRC) ( Site 0006) — Los Angeles, California, United States
  • Lucile Packard Children's Hospital ( Site 0001) — Palo Alto, California, United States
  • University of California Davis Health ( Site 0023) — Sacramento, California, United States
  • UCSF Medical Center at Mission Bay ( Site 0017) — San Francisco, California, United States
  • Children's Hospital Colorado ( Site 0013) — Aurora, Colorado, United States
  • University of Miami School of Medicine ( Site 0021) — Miami, Florida, United States
  • Children's Healthcare of Atlanta-Center for Advanced Pediatrics ( Site 0020) — Atlanta, Georgia, United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004) — Chicago, Illinois, United States
  • University of Michigan ( Site 0014) — Ann Arbor, Michigan, United States
  • M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007) — Minneapolis, Minnesota, United States
  • Mayo Clinic - Rochester ( Site 0015) — Rochester, Minnesota, United States
  • Morgan Stanley Children's Hospital ( Site 0018) — New York, New York, United States
  • Montefiore Medical Center ( Site 0024) — The Bronx, New York, United States
  • Levine Children's Hospital ( Site 0022) — Charlotte, North Carolina, United States
  • Duke University-Pediatrics ( Site 0008) — Durham, North Carolina, United States
  • Cincinnati Children's Hospital Medical Center ( Site 0002) — Cincinnati, Ohio, United States
  • Children's Hospital of Philadelphia (CHOP) ( Site 0003) — Philadelphia, Pennsylvania, United States
  • Children's Hospital of Pittsburgh - Department of Pediatrics ( Site 0011) — Pittsburgh, Pennsylvania, United States
  • Texas Children's Hospital ( Site 0005) — Houston, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record