Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Population: Patients over 18 years of age who have undergone kidney or simultaneous kidney/pancreas transplant and are high-risk CMV serostatus (D+/R-) at time of transplant who develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in our CMV stewardship monitoring initiative) and demonstrate proven or presumptive lack of cell-mediated immunity, either by CMI testing or risk factor screening.
Patients will be converted from treatment with ganciclovir derivatives to letermovir (480 mg tablet taken orally once daily) when the viral load via standard of care (SOC) weekly monitoring is < 500 IU/mL. This differs from SOC which only allows conversion to secondary prophylactic treatment after CMV is no longer detected on polymerase chain reaction (PCR) for 2 consecutive weeks. Thus, liberalization of conversion threshold will allow for reduced exposure to valganciclovir via reduced duration of therapy allowing relief of the myelosuppressive toxicity and creates an environment conducive to cell-mediated immunity (CMI).
The primary objective is to assess the efficacy of letermovir as secondary prophylaxis after treatment of CMV infection.
The secondary objective is to detect the 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Sandesh Parajuli, MBBS
- Phone Number: (608) 262-2122
- Email: sparajuli@medicine.wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- UW Hospital and Clinics
-
Sub-Investigator:
- Brad Astor, PhD
-
Sub-Investigator:
- Christopher Saddler, MD
-
Sub-Investigator:
- Jillian Descourouez, PharmD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Letermovir for CMV in Transplant Patients
Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir
|
480 mg taken orally once daily, for 84 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of valganciclovir (VGC) Treatment
Time Frame: up 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.
|
up to 2 months
|
|
Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL
Time Frame: up 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.
|
up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Positive Result for T-Cell Immunity Panel (TCIP) Testing
Time Frame: letermovir initiation (Day 0), at secondary prophylaxis completion (Week 12 +/- 28 days)
|
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. |
letermovir initiation (Day 0), at secondary prophylaxis completion (Week 12 +/- 28 days)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandesh Parajuli, MBBS, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0174
- A561000 (Other Identifier: UW Madison)
- 235208 (Other Identifier: OnCore ID)
- Protocol Version 8/22/25 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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