Letermovir to prevent CMV in children and adolescents after kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial gives letermovir to children and adolescents who are 4 to 52 weeks after a kidney transplant to characterize how the drug behaves in their bodies and to collect safety and tolerability data. Participants must weigh between 2.5 and <40 kg, have stable kidney function, and have undetectable CMV DNA before enrollment. Dosing is given orally as tablets or pellets, with pellets allowable via gastrostomy or nasogastric tube, and includes an intensive pharmacokinetics (IPK) sampling period. The primary focus is pharmacokinetics and short-term safety rather than efficacy outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.