Actively Recruiting
A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant Recipients Under 18 Years and Weighing Less Than 40 Kilograms
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-01
40
Participants Needed
16
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of letermovir to prevent cytomegalovirus (CMV) infection in children and adolescents who have received a kidney transplant and weigh less than 40 kilograms. This phase 1 study aims to understand how letermovir behaves in the body over time and to assess its safety and tolerability in this young population. Participants between 4 and 52 weeks after their kidney transplant will receive letermovir orally, either as tablets or pellets, or through a gastrostomy or nasogastric tube, for 7 consecutive days. The study is open-label and single-arm, focusing on weight-based dosing of letermovir. Throughout the study, researchers will monitor the drug levels in the body by measuring the area under the curve from dosing up to 24 hours on day 7. They will also track any adverse events up to 21 days and note if anyone stops the study drug due to side effects within 7 days. Participants will be assessed for kidney function stability and absence of CMV infection, with careful follow-up to evaluate the drug's safety and how well it is tolerated.
CONDITIONS
Brief Title
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recipient of a primary or secondary kidney transplant
- At least 4 weeks and not more than 52 weeks posttransplant at enrollment
- Stable kidney function after transplant
- Undetectable CMV DNA in plasma or whole blood within 14 days before enrollment
- Able to take letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube
- No conditions interfering with oral medication absorption (e.g., vomiting, diarrhea) from enrollment until pharmacokinetics sampling is complete
- Weighs at least 2.5 kg and less than 40 kg at enrollment
You will not qualify if you...
- Has CMV disease or suspected CMV disease between screening and enrollment
- On dialysis or plasmapheresis at enrollment
- Evidence of CMV viremia at any time from screening until enrollment
- Child-Pugh B or C hepatic insufficiency within 14 days before enrollment
- Multi-organ transplant recipient (e.g., kidney-pancreas)
- Any uncontrolled infection on the day of enrollment
- Requires mechanical ventilation or is hemodynamically unstable at enrollment
- Has received or is receiving protocol-specified prohibited medications
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive letermovir orally or via feeding tube for 7 consecutive days to evaluate pharmacokinetics and safety after kidney transplant.
1 baseline visit and multiple assessments up to Day 7
Duration - Up to 21 days
Participants are monitored for adverse events and safety for up to 21 days after treatment ends.
Periodic follow-up visits during this period
Trial Site Locations
Total: 16 locations
1
University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)
Los Angeles, California, United States, 90095
Actively Recruiting
3
Lucile Packard Children's Hospital ( Site 0001)
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of California Davis Health ( Site 0023)
Sacramento, California, United States, 95817
Actively Recruiting
5
UCSF Medical Center at Mission Bay ( Site 0017)
San Francisco, California, United States, 94158
Actively Recruiting
6
Children's Hospital Colorado ( Site 0013)
Aurora, Colorado, United States, 80045
Actively Recruiting
7
University of Miami School of Medicine ( Site 0021)
Miami, Florida, United States, 33136
Actively Recruiting
8
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)
Chicago, Illinois, United States, 60611
Actively Recruiting
9
University of Michigan ( Site 0014)
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank ( Site 0007)
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
11
Mayo Clinic - Rochester ( Site 0015)
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
Morgan Stanley Children's Hospital ( Site 0018)
New York, New York, United States, 10032
Actively Recruiting
13
Montefiore Einstein Center ( Site 0024)
The Bronx, New York, United States, 10467
Actively Recruiting
14
Levine Children's Hospital ( Site 0022)
Charlotte, North Carolina, United States, 28203
Actively Recruiting
15
Duke University-Pediatrics ( Site 0008)
Durham, North Carolina, United States, 27110
Actively Recruiting
16
Cincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
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Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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