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Can a simple infusion shield kidney transplants from a dangerous virus?

NCT ID NCT07096453

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a drug called Cytogam (CMVIG) can prevent cytomegalovirus (CMV) infection in kidney transplant patients who are switching to a new immunosuppressant. The researchers will measure antibody levels in 30 adult patients over 8 weeks to see how the drug works in the body. The goal is to find a better way to protect transplant recipients from this common and serious infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cytogam (CMVIG)
What this could lead to
If it works, this could point toward a way to prevent CMV infection in kidney transplant patients, reducing complications.
What could go wrong
This is a small early-phase pilot study with only 30 participants, so results may not apply broadly. It is testing antibody levels, not directly proving infection prevention.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

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

Started

Oct 2025

Expected to finish

Aug 2027

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 to 70 years

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: * Adult (18-70 year old) kidney transplant recipients * Patients transitioning from conventional CNI-based immunosuppression to co-stimulatory blockade (belatacept) immunosuppression OR patients who are stable on belatacept immunosuppression at the time of initial CYTOGAM infusion * CMV Ig Seronegative Recipient who received a CMV Ig seropositive Donor * EBV IgG Positive Exclusion Criteria: * Pregnant people * Subjects unwilling to sign consent and complete follow up visits * Subjects with IgA immunodeficiency * Subjects who are receiving IgG therapy or who have received IgG therapy within two months of study enrollment * Patients who do not speak English and would need a translator and translated consent materials in order to obtain informed consent

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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

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 of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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