Recruiting

Phase 1

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07199465

Conditions

Cytomegalovirus Prophylaxis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Letermovir

Study Details

Brief 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

Conditions

Cytomegalovirus Prophylaxis

Study ID

NCT07199465

Start date

Mar 30, 2026

Status verified date

Jul, 2026

Completion date

May 19, 2028

Anticipated

Primary completion date

Apr 14, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Weight-banded letermovir dosing

Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days.

Interventions

Letermovir

Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) 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 and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

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

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Study Coordinator

205-638-9781

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

310-825-5225

Lucile Packard Children's Hospital ( Site 0001)

Recruiting

Palo Alto, California, United States, 94304

Contacts

Study Coordinator

408-828-5120

University of California Davis Health ( Site 0023)

Recruiting

Sacramento, California, United States, 95817

Contacts

Study Coordinator

916-734-8036

UCSF Medical Center at Mission Bay ( Site 0017)

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

415-347-1885

Children's Hospital Colorado ( Site 0013)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-777-6263

University of Miami School of Medicine ( Site 0021)

Recruiting

Miami, Florida, United States, 33136

Contacts

Study Coordinator

305-243-4445

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Study Coordinator

312-227-2061

University of Michigan ( Site 0014)

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Study Coordinator

734-936-6280

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

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Study Coordinator

612-365-0013

Mayo Clinic - Rochester ( Site 0015)

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Study Coordinator

507-254-1714

Morgan Stanley Children's Hospital ( Site 0018)

Recruiting

New York, New York, United States, 10032

Contacts

Study Coordinator

212-305-2500

Montefiore Einstein Center ( Site 0024)

Recruiting

The Bronx, New York, United States, 10467

Contacts

Study Coordinator

718-741-2426

Levine Children's Hospital ( Site 0022)

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Study Coordinator

704-446-4842

Duke University-Pediatrics ( Site 0008)

Recruiting

Durham, North Carolina, United States, 27110

Contacts

Study Coordinator

919-684-6335

Cincinnati Children's Hospital Medical Center ( Site 0002)

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Study Coordinator

513-636-3017

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

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-590-1000

Texas Children's Hospital ( Site 0005)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

832-824-4330

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-07-13.