A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Merck Sharp & Dohme LLC · NCT07199465
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Up to age 17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 40
- US sites recruiting
- 21
- Study start
- March 30, 2026
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: Letermovir
Conditions: Cytomegalovirus Prophylaxis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)
Birmingham, AL 35233
Site contact: Study Coordinator · 205-638-9781
Children's Hospital Los Angeles ( Site 0016)
Los Angeles, CA 90027
Site contact: Study Coordinator · 323-660-2450
UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)
Los Angeles, CA 90095
Site contact: Study Coordinator · 310-825-5225
Lucile Packard Children's Hospital ( Site 0001)
Palo Alto, CA 94304
Site contact: Study Coordinator · 408-828-5120
University of California Davis Health ( Site 0023)
Sacramento, CA 95817
Site contact: Study Coordinator · 916-734-8036
UCSF Medical Center at Mission Bay ( Site 0017)
San Francisco, CA 94158
Site contact: Study Coordinator · 415-347-1885
Children's Hospital Colorado ( Site 0013)
Aurora, CO 80045
Site contact: Study Coordinator · 720-777-6263
University of Miami School of Medicine ( Site 0021)
Miami, FL 33136
Site contact: Study Coordinator · 305-243-4445
Children's Healthcare of Atlanta-Center for Advanced Pediatrics ( Site 0020)
Atlanta, GA 30329
Site contact: Study Coordinator · 404-785-5437
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)
Chicago, IL 60611
Site contact: Study Coordinator · 312-227-2061
University of Michigan ( Site 0014)
Ann Arbor, MI 48109
Site contact: Study Coordinator · 734-936-6280
M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)
Minneapolis, MN 55454
Site contact: Study Coordinator · 612-365-0013
Mayo Clinic - Rochester ( Site 0015)
Rochester, MN 55905
Site contact: Study Coordinator · 507-254-1714
Morgan Stanley Children's Hospital ( Site 0018)
New York, NY 10032
Site contact: Study Coordinator · 212-305-2500
Montefiore Medical Center ( Site 0024)
The Bronx, NY 10467
Site contact: Study Coordinator · 718-741-2426
Levine Children's Hospital ( Site 0022)
Charlotte, NC 28203
Site contact: Study Coordinator · 704-446-4842
Duke University-Pediatrics ( Site 0008)
Durham, NC 27710
Site contact: Study Coordinator · 919-684-6335
Cincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, OH 45229
Site contact: Study Coordinator · 513-636-3017
Children's Hospital of Philadelphia (CHOP) ( Site 0003)
Philadelphia, PA 19104
Site contact: Study Coordinator · 215-590-1000
Children's Hospital of Pittsburgh - Department of Pediatrics ( Site 0011)
Pittsburgh, PA 15224
Site contact: Study Coordinator · 412-864-6893
Texas Children's Hospital ( Site 0005)
Houston, TX 77030
Site contact: Study Coordinator · 832-824-4330
Study contacts (from the official record)
- Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
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