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New hope for kidney transplant patients: safer CMV prevention on the horizon?

NCT ID NCT06001320

Disease control Sponsor: Virginia Commonwealth University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a newer drug, letermovir, works better and causes fewer side effects than the standard drug valganciclovir for preventing CMV infection in African American kidney transplant recipients. About 30 high-risk patients will take letermovir for 6 months after transplant, and their results will be compared to a similar group from the past who took valganciclovir. The goal is to reduce the risk of CMV-related illness and side effects like low white blood cell counts.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

30 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Historical Control group: Inclusion Criteria 1. Kidney transplant recipients 2. Male or female age ≥ 18 years old 3. African American race 4. CMV high risk (D+/R-) 5. received valganciclovir for CMV prophylaxis Historical Control group: Exclusion 1. Re-transplantation 2. Panel of reactive antibody ≥80% at the time of transplant 3. Positive cytotoxic cross match at the time of transplant Experimental Group Inclusion Criteria 1. Kidney transplant recipients 2. Male or female age ≥ 18 years old 3. African American race 4. CMV high risk (D+/R-) 5. Ability to provide informed consent before any trial related activities Exclusion Criteria 1. Re-transplantation 2. Panel of reactive antibody ≥80% at the time of transplant 3. Positive cytotoxic cross match at the time of transplant 4. Pregnancy and Breastfeeding 5. Prisoners 6. Patients with hypersensitivity to acyclovir, valacyclovir or any of its components 7. Patients with hypersensitivity to Letermovir or any of its components 8. If Patients are taking any of these medications: pimozide, ergot alkaloids (ergotamine, dihydroergotamine), or pitavastatin/simvastatin co-administered with cyclosporine, we will work with the prescribing physician to find an appropriate replacement therapy which will not interfere with any study-related interventions. Otherwise, participants will be excluded from the study.

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection prevention target

As listed by the trial registrant

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

CMV Kidney transplant; complications

Contacts and locations

Locations

  • VCU Medical Center

    Richmond, Virginia, 23219, United States

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