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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorMerck Sharp & Dohme LLC

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Letermovir

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators