Actively Recruiting
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
40
Participants Needed
14
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial 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
CONDITIONS
Official 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 post kidney transplant at enrollment
- Stable kidney function after transplant
- Undetectable CMV DNA from plasma or whole blood within 14 days before enrollment
- Able to take letermovir tablets or pellets by mouth, or pellets via gastrostomy or nasogastric tube
- No conditions interfering with oral medication absorption from enrollment until pharmacokinetic sampling completion
- Weighs between 2.5 and less than 40 kilograms 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 from screening until enrollment
- Child-Pugh B or C liver insufficiency within 14 days before enrollment
- Recipient of multi-organ transplant (e.g., kidney-pancreas)
- Has any uncontrolled infection on enrollment day
- Requires mechanical ventilation or is hemodynamically unstable at enrollment
- Has received or is receiving prohibited medications specified by the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 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
Duke University Medical Center ( Site 0008)
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Cincinnati Children's Hospital Medical Center ( Site 0002)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here