CMV InfectionPhase 4NCT07571135
Letermovir vs Valganciclovir in CMV R+ Kidney Transplant
A Phase 4 study testing Letermovir and Valganciclovir CMV Prophylaxis in people with CMV Infection and CMV, run by Elisabeth Kincaide at 1 site in United States.
Trial summary
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Infection, CMV, CMV Viremia
- What is being tested?
- Letermovir and Valganciclovir CMV Prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Nov 2028
- 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
- ≥18 years old
- Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant
- Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation
- Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation
Who cannot join
- Multiorgan organ transplant
- Received previous solid organ transplant or HSCT
- Unable to take oral medications
- Uncontrolled infections at the time of enrollment
- Hemodynamically unstable or on mechanical ventilation at the time of enrollment
- Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor
Show all 16Show fewer
- Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation
- Received any anti-CMV drug treatment within 7 days prior to enrollment
- Current user of recreational or illicit drugs or alcohol dependence
- History of CMV disease prior to enrollment
- Previously participated in a letermovir study or any other study with CMV investigational agents
- On dialysis or plasmapheresis at the time of enrollment
- Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations
- Child-Pugh Class C severe hepatic insufficiency
- Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study
- Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine
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
University Hospital
San Antonio, Texas, 78229
Elisabeth Kincaide, PharmD, 210-743-4086, Elisabeth.Kincaide@uhtx.com
Sean Moore, BSN, RN, 210-475-2559, Sean.Moore2@uhtx.com
About this study
Official title: Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.
The main question the study wants to answer is:
Read more
- Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?
The study will also look at other important questions:
- Is letermovir easier for patients to tolerate than valganciclovir?
- How long does it take for a CMV infection to appear in each group?
- Are there differences in "breakthrough" CMV infections between the two medications?
- For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
Read the detailed description
The purpose of this study is to evaluate the efficacy and tolerability of letermovir compared to standard-of-care, valganciclovir, for the prevention of clinically significant cytomegalovirus (CMV) infection in CMV moderate risk adult kidney transplant recipients.
A 3:1 match of historical valganciclvoir:letermovir arm
- Matching criteria:
- Induction agent: lymphocyte-depleting (rabbit anti-thymocyte globulin or alemtuzumab) versus non-lymphocyte depleting (basiliximab)
- Delayed graft function (dialysis within one week of kidney transplant)
- MMF dose at de novo discharge (weight-based vs non-weight based)
Study Arms:
- Letermovir Arm:
- Letermovir 480 mg PO daily starting POD 4 through 10 OR
- Letermovir 240 mg PO daily if given concomitantly with cyclosporine, for 90 days
- Will be given with acyclovir 400 mg PO BID (or 200 PO BID if CrCl <25) for 90 days
- Historical Arm:
- Valganciclovir 450 mg PO daily (adjusted for renal function) for 90 days
- CrCl 25-30: valganciclovir 450 mg PO q 48 h
- CrCl <25: Valganciclovir 450 mg PO three times weekly
Outcomes:
- Primary Efficacy Objective:
- Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir
- Clinically Significant CMV Infection: CMV disease or symptomatic viremia requiring therapeutic intervention
- Secondary Objectives:
- Tolerability:
- Proportion of patients with leukopenia or neutropenia (composite) in patients who received letermovir versus standard of care valganciclovir
- Leukopenia: white blood cells < 3500 cells/uL
- Neutropenia: absolute neutrophil count < 1000 cells/uL
- Intolerability or early drug discontinuation
- Proportion of patients who discontinue the study drug prematurely due to adverse events or intolerance
- Efficacy:
- Time-to clinically significant CMV infection (days)
- Breakthrough CMV while on CMV prophylaxis
- CMV Viremia
- Detection of CMV DNA in blood via PCR
- Clinically significant CMV infection
- CMV resistance
- Detection of CMV strains with genotypic or phenotypic resistance to antiviral agents used in prophylaxis or treatment
- Conditions
- CMV Infection, CMV, CMV Viremia, CMV Disease
- Being tested
- Letermovir, Valganciclovir CMV Prophylaxis
- Keywords
- CMV, Kidney Transplant, Letermovir, Moderate Risk, CMV Prophylaxis, Valganciclovir, Neutropenia
- Medical subject headings
- Cytomegalovirus Infections, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Letermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant
Valganciclovir CMV ProphylaxisDrug
Valganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control)
| Study group | Role | What they receive |
|---|---|---|
| Letermovir | Active comparator | Prospective letermovir prophylaxis Receives: Drug: Letermovir |
| Valganciclovir | Other | Historical valganciclovir prophylaxis Receives: Drug: Valganciclovir CMV Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV Infection
Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir.
Measured: 12 months post kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV InfectionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention arm with Letermovir compared to historical arm receiving Valganciclovir
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabeth Kincaide
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Elisabeth Kincaide, Bexar County Hospital District dba University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571135
- Sponsor's protocol ID
- STUDY00000831
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.
- ClinicalTrials.gov ID
- NCT07571135
- Acronym / sponsor ID
- STUDY00000831
- Conditions
- CMV Infection, CMV, CMV Viremia, CMV Disease
- Keywords
- CMV, Kidney Transplant, Letermovir, Moderate Risk, CMV Prophylaxis, Valganciclovir, Neutropenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Elisabeth KincaideOther government
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 6 May 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 study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.
The main question the study wants to answer is:
- Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?
The study will also look at other important questions:
- Is letermovir easier for patients to tolerate than valganciclovir?
- How long does it take for a CMV infection to appear in each group?
- Are there differences in "breakthrough" CMV infections between the two medications?
- For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
Detailed description
The purpose of this study is to evaluate the efficacy and tolerability of letermovir compared to standard-of-care, valganciclovir, for the prevention of clinically significant cytomegalovirus (CMV) infection in CMV moderate risk adult kidney transplant recipients.
A 3:1 match of historical valganciclvoir:letermovir arm
- Matching criteria:
- Induction agent: lymphocyte-depleting (rabbit anti-thymocyte globulin or alemtuzumab) versus non-lymphocyte depleting (basiliximab)
- Delayed graft function (dialysis within one week of kidney transplant)
- MMF dose at de novo discharge (weight-based vs non-weight based)
Study Arms:
- Letermovir Arm:
- Letermovir 480 mg PO daily starting POD 4 through 10 OR
- Letermovir 240 mg PO daily if given concomitantly with cyclosporine, for 90 days
- Will be given with acyclovir 400 mg PO BID (or 200 PO BID if CrCl <25) for 90 days
- Historical Arm:
- Valganciclovir 450 mg PO daily (adjusted for renal function) for 90 days
- CrCl 25-30: valganciclovir 450 mg PO q 48 h
- CrCl <25: Valganciclovir 450 mg PO three times weekly
Outcomes:
- Primary Efficacy Objective:
- Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir
- Clinically Significant CMV Infection: CMV disease or symptomatic viremia requiring therapeutic intervention
- Secondary Objectives:
- Tolerability:
- Proportion of patients with leukopenia or neutropenia (composite) in patients who received letermovir versus standard of care valganciclovir
- Leukopenia: white blood cells < 3500 cells/uL
- Neutropenia: absolute neutrophil count < 1000 cells/uL
- Intolerability or early drug discontinuation
- Proportion of patients who discontinue the study drug prematurely due to adverse events or intolerance
- Efficacy:
- Time-to clinically significant CMV infection (days)
- Breakthrough CMV while on CMV prophylaxis
- CMV Viremia
- Detection of CMV DNA in blood via PCR
- Clinically significant CMV infection
- CMV resistance
- Detection of CMV strains with genotypic or phenotypic resistance to antiviral agents used in prophylaxis or treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention arm with Letermovir compared to historical arm receiving Valganciclovir
| Arm | Type | Receives |
|---|---|---|
| Letermovir | Active comparator | Drug: LetermovirProspective letermovir prophylaxis |
| Valganciclovir | Other | Drug: Valganciclovir CMV ProphylaxisHistorical valganciclovir prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant
- Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation
- Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation
Key exclusion criteria (16 listed)
- Multiorgan organ transplant
- Received previous solid organ transplant or HSCT
- Unable to take oral medications
- Uncontrolled infections at the time of enrollment
- Hemodynamically unstable or on mechanical ventilation at the time of enrollment
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 |
|---|---|---|
| LetermovirLetermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant | Drug | Letermovir |
| Valganciclovir CMV ProphylaxisValganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control) | Drug | Valganciclovir |
Primary outcome
CMV Infection
Time frame: 12 months post kidney transplant
Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir.
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 8 May 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.
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 and Valganciclovir CMV Prophylaxis in people with CMV Infection and CMV, run by Elisabeth Kincaide 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 4 inclusion and 16 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 8 May 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 Elisabeth Kincaide, PharmD (210-743-4086, Elisabeth.Kincaide@uhtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV Infection (time frame: 12 months post kidney transplant). 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 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.