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NCT07199465PHASE1Recruiting

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

Merck Sharp & Dohme LLC

Start Date

3/30/2026

Completion Date

5/19/2028

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

Eligibility Criteria

Age Range: No minimum to 17 years

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

Interventions

DRUG

Letermovir

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Conditions

Cytomegalovirus Prophylaxis

Locations

University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)

Birmingham, Alabama 35233

United States

UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)

Los Angeles, California 90095

United States

Lucile Packard Children's Hospital ( Site 0001)

Palo Alto, California 94304

United States

University of California Davis Health ( Site 0023)

Sacramento, California 95817

United States

UCSF Medical Center at Mission Bay ( Site 0017)

San Francisco, California 94158

United States

Children's Hospital Colorado ( Site 0013)

Aurora, Colorado 80045

United States

University of Miami School of Medicine ( Site 0021)

Miami, Florida 33136

United States

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)

Chicago, Illinois 60611

United States

University of Michigan ( Site 0014)

Ann Arbor, Michigan 48109

United States

M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)

Minneapolis, Minnesota 55454

United States

Mayo Clinic - Rochester ( Site 0015)

Rochester, Minnesota 55905

United States

Morgan Stanley Children's Hospital ( Site 0018)

New York, New York 10032

United States

Montefiore Einstein Center ( Site 0024)

The Bronx, New York 10467

United States

Levine Children's Hospital ( Site 0022)

Charlotte, North Carolina 28203

United States

Duke University-Pediatrics ( Site 0008)

Durham, North Carolina 27110

United States

Cincinnati Children's Hospital Medical Center ( Site 0002)

Cincinnati, Ohio 45229

United States

Children's Hospital of Philadelphia (CHOP) ( Site 0003)

Philadelphia, Pennsylvania 19104

United States

Texas Children's Hospital ( Site 0005)

Houston, Texas 77030

United States