A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letermovir.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus Prophylaxis. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug Letermovir
Administered orally (as tablets/pellets) or via gastrostomy or nasogastric tube (as pellets) for 7 consecutive days.
Primary outcome measures
- Area Under the Curve From Time 0 to 24 Hours (AUC0-24) [Time frame: Day 7: Predose and at designated timepoints post-dose (up to 24 hours)]
Secondary outcome measures (2)
- Percentage of Participants Who Experience an Adverse Event (AE) [Time frame: Up to 21 days]
- Percentage of Participants Who Discontinue Study Intervention Due to an AE [Time frame: Up to 7 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019) — Birmingham
- UCLA Clinical & Translational Research Center (CTRC) ( Site 0006) — Los Angeles
- Lucile Packard Children's Hospital ( Site 0001) — Palo Alto
- University of California Davis Health ( Site 0023) — Sacramento
- UCSF Medical Center at Mission Bay ( Site 0017) — San Francisco
- Children's Hospital Colorado ( Site 0013) — Aurora
- University of Miami School of Medicine ( Site 0021) — Miami
- Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004) — Chicago
- … and 10 more centers
Identifiers
NCT: NCT07199465 · 8228-077 · MK-8228-077