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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Cytomegalovirus Prophylaxis

Treatments: Drug: Letermovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT07199465

MK-8228-077 (Other Identifier)

8228-077

Details and patient eligibility

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

Enrollment: 40 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Weight-banded letermovir dosing

Experimental group

Description:

Participants who are between 4 and 52 weeks post-KT will receive letermovir for 7 consecutive days.

Treatment:

Drug: Letermovir