AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)

RecruitingPhase 1Ages any - 17 YearsAllMerck Sharp & Dohme LLC
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ2.5 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
๐Ÿ’Š

What it tests

  • Letermovir
๐Ÿ“

Where

21 sites
University of Alabama at Birmingham - School of Medicine - Pediatrics ( Site 0019)
Birmingham, United States
Children's Hospital Los Angeles ( Site 0016)
Los Angeles, United States
UCLA Clinical & Translational Research Center (CTRC) ( Site 0006)
Los Angeles, United States
Lucile Packard Children's Hospital ( Site 0001)
Palo Alto, United States
University of California Davis Health ( Site 0023)
Sacramento, United States
UCSF Medical Center at Mission Bay ( Site 0017)
San Francisco, United States
Children's Hospital Colorado ( Site 0013)
Aurora, United States
University of Miami School of Medicine ( Site 0021)
Miami, United States

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy