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New hope for kidney transplant patients: drug targets rejection

NCT ID NCT07613359

Disease control Sponsor: Takeda 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 2 times

Summary

This study tests a drug called mezagitamab in people who have had a kidney transplant and are experiencing a type of rejection called antibody-mediated rejection (AMR). AMR happens when the body's immune system attacks the donor kidney, which can lead to kidney failure. The study will compare two different doses of mezagitamab to a placebo to see if the drug is safe and helps control inflammation and keep the kidney working well. About 36 adults will take part.

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

About 36 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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.

Key inclusion criteria: 1. The participant aged 18 to 80 years. 2. The participant must have a biopsy-confirmed diagnosis of active or chronic active late AMR (defined as greater than \[\>\] 6 month after kidney transplant) without concurrent definitive TCMR (Grade 1a and above) as defined by the 2022 Banff classification. 3. Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window. 4. If the participant has received treatment for rejection, then the repeat biopsy and donor specific antibody (DSA) testing must have been performed at least 6 weeks after stopping the treatment. 5. The participant with either human leukocyte antigen (HLA) class I and/or II DSA. 6. eGFR \> 30 milliliters per minute per 1.73 square meters (mL/min/1.73m\^2). Key exclusion criteria: 1. The participant has blood type A, B, AB, or O (ABO) incompatible transplant. 2. The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants. 3. Participant likely to require renal replacement therapy within the subsequent 30 days. 4. Participants who have received an anti-cluster of differentiation 38 (CD38) therapy in the last 1 year or have past history of failing to achieve AMR resolution despite treatment with an anti-CD38 therapy. 5. The participant has received any previous treatment with other immunosuppressant or immunomodulatory therapy: a) Within 6 months of signing the informed consent form (ICF) as listed below: * Complement system inhibitors (such as, eculizumab). * Proteasome inhibitors (such as, bortezomib). * Interleukin-6 (IL-6)/IL-6R antibody (such as, tocilizumab). * Anti-cluster of differentiation 20 (CD20) antibody (such as, rituximab). b) Within 6 weeks of signing the ICF as listed below: * Intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) or plasmapheresis 6. The participant has active infection with hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 7. Participant with serious infection within 2 weeks or with opportunistic infection within 2 months prior to signing ICF. Participant with active or untreated tuberculosis, or those with high suspicion of tuberculosis are also excluded. 8. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ. Key Note: Other protocol specified inclusion and exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

acute transplant rejection transplant rejection

As listed by the trial registrant

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

Antibody-mediated rejection (AMR)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    35 sites in 5 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • CHU Bordeaux, CHU Pellegrin

    Bordeaux, 33076, France

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, France

  • Cleveland Clinic - Cleveland

    Cleveland, Ohio, 44195, United States

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Hopital Edouard Herriot (HEH)

    Lyon, 69003, France

  • Hopital Henri Mondor

    Créteil, 94000, France

  • Intermountain Healthcare

    Murray, Utah, 84107, United States

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650, Japan

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520, Japan

  • Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic

    San Francisco, California, 94118, United States

  • Kliniken Universitatsklinikum Bochum GmbH

    Bochum, North Rhine-Westphalia, 44892, Germany

  • Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen

    München, 81377, Germany

  • NYU Langone Health - Transplant Associates

    New York, New York, 10016, United States

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8520, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-8585, Japan

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong, 250013, China

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangdong, Guangdong, 510080, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530007, China

  • Tongji Hospital Affiliated to Tongji Medicine University

    Wuhan, Hubei, 430075, China

  • UCLA University of California Los Angeles

    Los Angeles, California, 90024, United States

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45122, Germany

  • Universitaetsklinikum Muenster

    Münster, Germany

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

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

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine - Nephrology and Kidney Transplantation Medicine

    New York, New York, 10021, United States

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610000, China

  • Yochomachi Clinic

    Shinjuku-ku, Tokyo, 162-0055, Japan