Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New shot could help kidney transplant patients fight rejection

NCT ID NCT06503731

Disease control Sponsor: argenx 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a drug called efgartigimod, given as a shot under the skin, for people who have antibody-mediated rejection after a kidney transplant. The trial includes 30 adults who received a kidney at least 6 months ago and have signs of rejection. Participants will receive either the drug or a placebo, along with their usual anti-rejection medications, for 48 weeks, followed by 24 weeks of observation. The goal is to see if the drug is safe and can help control rejection.

What this could mean

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

Active substance
Efgartigimod PH20 SC (a drug given by injection under the skin)
What this could lead to
If it works, this could offer a new way to treat antibody-mediated rejection in kidney transplant patients, potentially helping to preserve kidney function and reduce the need for stronger treatments.
What could go wrong
This is an early Phase 2 trial with only 30 participants, so results may not apply to everyone. The drug is tested alongside standard immunosuppression, and its long-term safety and effectiveness are not yet known.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 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: * The participant is within the ages of 18 and 80 years old * The participant had a kidney transplant (living or deceased donor) at least 6 months before the study * The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study * A participant may be allowed into the study if they receive the following medications: 1. Received mycophenolate mofetil for at least 20 weeks before the study 2. Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study 3. Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study 4. Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study Exclusion Criteria: * Confirmed T-cell or mixed rejection at time of the study * Recent change in immunosuppressive therapy agents * Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk * Pregnant or lactating state or intention to become pregnant during the study The complete list of criteria can be found in the protocol

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Antibody-mediated rejection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute transplant rejection

As listed by the trial registrant

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

Antibody-mediated rejection

Contacts and locations

Locations

  • Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus

    Vienna, 1090, Austria

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33076, France

  • Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon

    La Tronche, 38700, France

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil

    Toulouse, 31059, France

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • Duke University Hospital

    Durham, North Carolina, 27705, United States

  • Hospital Del Mar

    Barcelona, 08003, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Bellvitge

    Barcelona, 08907, Spain

  • Institut klinicke a experimentalni mediciny (IKEM)

    Prague, 140-21, Czechia

  • London Health Sciences Centre

    London, N6A 5A5, Canada

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitair Ziekenhuis (UZ) Gent

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35233, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60615, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.