What this study is
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
What's being tested
- Letermovir
Intervention · DRUG
Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Study details
- Official title
- A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Cytomegalovirus Prophylaxis
- Enrolling
- 40 people
- Starts
- 2026-03-30
- Est. completion
- 2028-05-19
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (22)
22 openUniversity of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)
Birmingham, Alabama, United States
- Study Coordinator · Contact205-638-9781
RecruitingChildren's Hospital Los Angeles ( Site 0016)
Los Angeles, California, United States
- Study Coordinator · Contact323-660-2450
RecruitingUCLA Clinical & Translational Research Center (CTRC) ( Site 0006)
Los Angeles, California, United States
- Study Coordinator · Contact310-825-5225
RecruitingLucile Packard Children's Hospital ( Site 0001)
Palo Alto, California, United States
- Study Coordinator · Contact408-828-5120
RecruitingUniversity of California Davis Health ( Site 0023)
Sacramento, California, United States
- Study Coordinator · Contact916-734-8036
RecruitingUCSF Medical Center at Mission Bay ( Site 0017)
San Francisco, California, United States
- Study Coordinator · Contact415-347-1885
RecruitingChildren's Hospital Colorado ( Site 0013)
Aurora, Colorado, United States
- Study Coordinator · Contact720-777-6263
RecruitingUniversity of Miami School of Medicine ( Site 0021)
Miami, Florida, United States
- Study Coordinator · Contact305-243-4445
RecruitingChildren's Healthcare of Atlanta-Center for Advanced Pediatrics ( Site 0020)
Atlanta, Georgia, United States
- Study Coordinator · Contact404-785-5437
RecruitingAnn & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)
Chicago, Illinois, United States
- Study Coordinator · Contact312-227-2061
RecruitingUniversity of Michigan ( Site 0014)
Ann Arbor, Michigan, United States
- Study Coordinator · Contact734-936-6280
RecruitingM Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)
Minneapolis, Minnesota, United States
- Study Coordinator · Contact612-365-0013
RecruitingMayo Clinic - Rochester ( Site 0015)
Rochester, Minnesota, United States
- Study Coordinator · Contact507-254-1714
RecruitingMorgan Stanley Children's Hospital ( Site 0018)
New York, New York, United States
- Study Coordinator · Contact212-305-2500
RecruitingMontefiore Medical Center ( Site 0024)
The Bronx, New York, United States
- Study Coordinator · Contact718-741-2426
RecruitingLevine Children's Hospital ( Site 0022)
Charlotte, North Carolina, United States
- Study Coordinator · Contact704-446-4842
RecruitingDuke University-Pediatrics ( Site 0008)
Durham, North Carolina, United States
- Study Coordinator · Contact919-684-6335
RecruitingCincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, Ohio, United States
- Study Coordinator · Contact513-636-3017
RecruitingChildren's Hospital of Philadelphia (CHOP) ( Site 0003)
Philadelphia, Pennsylvania, United States
- Study Coordinator · Contact215-590-1000
RecruitingChildren's Hospital of Pittsburgh - Department of Pediatrics ( Site 0011)
Pittsburgh, Pennsylvania, United States
- Study Coordinator · Contact412-864-6893
RecruitingTexas Children's Hospital ( Site 0005)
Houston, Texas, United States
- Study Coordinator · Contact832-824-4330
RecruitingUniversity of Wisconsin ( Site 0012)
Madison, Wisconsin, United States
- Study Coordinator · Contact608-264-1400
Recruiting
Study team
Sponsor
Merck Sharp & Dohme LLC
Study ID 8228-077
Study director
Medical Director
Merck Sharp & Dohme LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.