Health TrialsbyHealthPanel

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

ConditionsCytomegalovirus InfectionsKidney Transplant InfectionPancreas Transplant
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney/pancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Letermovir

    Drug

    480 mg taken orally once daily, for 84 days

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Letermovir for CMV in Transplant PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL

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.

Time frame
up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study)
2

Duration of valganciclovir (VGC) Treatment

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

Time frame
up to 2 months

Secondary outcomes

1

Number of Participants with Positive Result for T-Cell Immunity Panel (TCIP) Testing

To test the hypothesis that letermovir will be associated with increased development of cytomegalovirus-specific cell-mediated immunity when compared to a literature-based control, development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T-Cell Immunity Testing per manufacturer specifications will be measured. TCIP will be collected from the medical record at these timepoints if possible. Given SOC, access to this test is not always available to all patients at both timepoints.

Time frame
letermovir initiation (Day 0), at secondary prophylaxis completion (Week 12 +/- 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
Apply now