Kidney TransplantPhase 4MISP CMVNCT07706166
Letermovir for R+ Study
A Phase 4 study testing Letermovir in people with Kidney Transplant and Liver Transplant, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV. Participants will take letermovir for 84 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Liver 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
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2029
- Phase
- Phase 4
- 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
- Adults who are at moderate risk for CMV after transplant (CMV IGG+, including D+/R+ or D-/R+)
- Adults who received a kidney transplant, liver transplant, or any combination thereof
Who cannot join
- Known contraindication to letermovir or its excipients
- Current participation in another CMV related study
- Unwilling or unable to participate in the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Office of Clinical Research Department of Surgery contact
Margaret R Jorgenson, PharmD contact
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53792
About this study
Official title: An Interventional Study of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection in Moderate Risk (R+) Abdominal Solid Organ Transplant Recipients
The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV.
Participants will take letermovir for 84 days.
Read the detailed description
This study is being done to see if letermovir prevents CMV reactivation in seropositive participants with a kidney or liver transplant.
- Conditions
- Kidney Transplant, Liver Transplant
- Being tested
- Letermovir
- Keywords
- Moderate risk for CMV infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
1 tablet by mouth, once daily, for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Receive letermovir | Experimental | Participants will take letermovir Receives: Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of letermovir as a prophylaxis of CMV
Efficacy will be measured through comparative rates of antiviral failure. Failure will be defined as withdrawal due to intolerance or breakthrough viral replication to a viral load >1000 IU/mL.
Measured: 84 days
Secondary outcomes (1)
Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity
To be measured using the Eurofins-Viracor CMV inSIGHT™ T Cell Immunity testing. The test measures the strength of T cell responses to Cytomegalovirus (CMV) specific antigens.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 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
- David Al-Adra, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706166
- Sponsor's protocol ID
- 2026-0529
- Other IDs
- UWMSN | SMPH | Surgery - Trans, Protocol Version 3/12/26
- Acronym
- MISP CMV
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection in Moderate Risk (R+) Abdominal Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT07706166
- Acronym / sponsor ID
- MISP CMV / 2026-0529
- Conditions
- Kidney Transplant, Liver Transplant
- Keywords
- Moderate risk for CMV infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Jul 2026 (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.
The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV.
Participants will take letermovir for 84 days.
Detailed description
This study is being done to see if letermovir prevents CMV reactivation in seropositive participants with a kidney or liver transplant.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receive letermovir | Experimental | Drug: LetermovirParticipants will take letermovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults who are at moderate risk for CMV after transplant (CMV IGG+, including D+/R+ or D-/R+)
- Adults who received a kidney transplant, liver transplant, or any combination thereof
Key exclusion criteria (3 listed)
- Known contraindication to letermovir or its excipients
- Current participation in another CMV related study
- Unwilling or unable to participate in the study protocol
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 |
|---|---|---|
| Letermovir1 tablet by mouth, once daily, for 84 days | Drug | Receive letermovir |
Primary outcome
Efficacy of letermovir as a prophylaxis of CMV
Time frame: 84 days
Efficacy will be measured through comparative rates of antiviral failure. Failure will be defined as withdrawal due to intolerance or breakthrough viral replication to a viral load >1000 IU/mL.
1 secondary outcome
Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity
Time frame: 84 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 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
RecruitingPhase 2
Advancing Transplantation Outcomes in Children
Kidney Transplant
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.
Office of Clinical Research Department of Surgery contact
Margaret R Jorgenson, PharmD contact
David Al-Adra, MD 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 4 study testing Letermovir in people with Kidney Transplant and Liver Transplant, 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Office of Clinical Research Department of Surgery (608-576-0788, surgeryresearch@surgery.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of letermovir as a prophylaxis of CMV (time frame: 84 days). 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 29 Sep 2026.