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Letermovir for CMV in Kidney and Pancreas Transplant Recipients

This study is looking at how well letermovir (Prevymis) works to prevent cytomegalovirus (CMV) infection from coming back in adult patients who have had a kidney or kidney/pancreas transplant. You might be able to join if you've had one of these transplants, are at high risk for CMV, and have developed a CMV infection that needs treatment. The study will measure how many times CMV infection recurs and how long patients need to take another medication called valganciclovir. The goal is to see if letermovir can effectively prevent CMV recurrence. The current status of this study is unclear, and it plans to enroll 90 participants.

Study design
This is an interventional study with a planned enrollment of 90 participants. The phase of the study is not specified.
What's involved
Participants will take letermovir (480 mg orally once daily) for 84 days and will be in the study for about 6 months.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes for up to 90 days after stopping secondary prophylaxis (up to 6 months on study) and for up to 2 months for valganciclovir treatment duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06407232

Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients

Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Wisconsin, Madison
~90 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Letermovir

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL
Measured over up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study)
+1 more outcome measured

Conditions

Cytomegalovirus Infections
Kidney Transplant Infection
Pancreas Transplant

Explore related trials

Cytomegaloviral InfectionKidney TransplantationPancreas TransplantationC-MAF-INDUCING PROTEINCytomegaloviral Infection

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Sandesh Parajuli, MBBS · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Sandesh Parajuli, MBBS
[email protected]
(608) 262-2122
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

undergone kidney or simultaneous kidney/pancreas transplant
high-risk CMV serostatus (D+/R-) at time of transplant
develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in the CMV stewardship monitoring initiative)
demonstrate proven or presumptive lack of CMI, either by CMI testing or risk factor screening
able to provide informed consent to participate

Exclusion

contraindication to letermovir or its excipients
develop ganciclovir-resistant CMV infection
currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent
unable or unwilling, in the opinion of the Investigator, to comply with the protocol
pregnant or breastfeeding

What this trial measures

  • Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mLup to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study)

    To test the hypothesis that letermovir will be associated with reduced incidence of recurrent viremia, recurrence will be measured defined as incidence of any cytomegalovirus replication greater than 1000 IU/mL requiring treatment after withdrawal of secondary prophylaxis.

  • Duration of valganciclovir (VGC) Treatmentup to 2 months

    To test the hypothesis that letermovir will be associated with reduced duration of (val)ganciclovir treatment, the duration of VGC treatment will be measured.