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New drug may offer safer CMV prevention for kidney transplant patients

NCT ID NCT07571135

Prevention Sponsor: Elisabeth Kincaide Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if letermovir works as well as valganciclovir in preventing CMV infection in 300 kidney transplant patients who are CMV-positive. Both drugs are given for 90 days after transplant. Researchers will also check if letermovir is easier to tolerate and how long it takes for infections to appear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (both arms): * ≥18 years old * Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant Inclusion Criteria (letermovir arm): * 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 Exclusion Criteria (both arms): * 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 * 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 Exclusion Criteria (letermovir arm): * 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

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection neutropenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CMV CMV disease CMV infection CMV viremia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital

    San Antonio, Texas, 78229, United States

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