A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Purpose
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
Condition
- Cytomegalovirus Prophylaxis
Eligibility
- Eligible Ages
- Under 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Weight-banded letermovir dosing |
Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days. |
|
Recruiting Locations
Los Angeles, California 90095
Study Coordinator
310-825-5225
Palo Alto, California 94304
Study Coordinator
408-828-5120
Sacramento, California 95817
Study Coordinator
916-734-8036
San Francisco, California 94158
Study Coordinator
415-347-1885
Aurora, Colorado 80045
Study Coordinator
720-777-6263
Chicago, Illinois 60611
Study Coordinator
312-227-2061
Ann Arbor, Michigan 48109
Study Coordinator
734-936-6280
Rochester, Minnesota 55905
Study Coordinator
507-254-1714
New York, New York 10032
Study Coordinator
212-305-2500
Durham, North Carolina 27710
Study Coordinator
919-684-6335
Cincinnati, Ohio 45229
Study Coordinator
513-636-7499
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC