Cytomegalovirus InfectionsPhase 3NCT06407232
Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
A Phase 3 study testing Letermovir in people with Cytomegalovirus Infections and Kidney Transplant Infection, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections, Kidney Transplant Infection, Pancreas Transplant
- What is being tested?
- Letermovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2024to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Hospital and Clinics
Madison, Wisconsin, 53792
Brad Astor, PhD
Christopher Saddler, MD
About this study
Official title: An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
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.
Read the 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.
- Being tested
- Letermovir
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Also called Prevymis
480 mg taken orally once daily, for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Letermovir for CMV in Transplant Patients | Experimental | Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir Receives: Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study)
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.
Measured: 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.
Measured: letermovir initiation (Day 0), at secondary prophylaxis completion (Week 12 +/- 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start8 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Sandesh Parajuli, MBBS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407232
- Sponsor's protocol ID
- 2024-0174
- Other IDs
- A561000, Protocol Version 8/22/25, 235208
- Status last verified
- Jun 2026
- First submitted
- 6 May 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
- ClinicalTrials.gov ID
- NCT06407232
- Acronym / sponsor ID
- 2024-0174
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letermovir for CMV in Transplant Patients | Experimental | Drug: LetermovirEnrolled participants will be converted from treatment with ganciclovir derivatives to letermovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetermovirAlso: Prevymis480 mg taken orally once daily, for 84 days | Drug | Letermovir for CMV in Transplant Patients |
Primary outcome
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.
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandesh Parajuli, MBBS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letermovir in people with Cytomegalovirus Infections and Kidney Transplant Infection, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandesh Parajuli, MBBS ((608) 262-2122, sparajuli@medicine.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.