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New drug could save transplanted kidneys from rejection

NCT ID NCT06685757

Disease control Sponsor: Biogen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called felzartamab in people who received a kidney transplant and later developed antibody-mediated rejection (AMR), where the immune system attacks the new kidney. The drug targets immune cells that make harmful antibodies, aiming to reduce kidney damage and keep the transplant working longer. About 132 participants will receive either felzartamab or a placebo for 24 weeks, then all will get felzartamab for another 28 weeks. The main goal is to see if the drug can make kidney tissue look normal or near normal after treatment.

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

132 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jun 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 75 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: * Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria. * Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors). * Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen bead-based assays within 3 months prior to randomization. Key Exclusion Criteria: * Transplant: Blood type (ABO)-incompatible transplant. * History of multiple organ transplants including en bloc and dual kidney transplants. * Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator. * Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing AMR and to determine eligibility: 1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX. 2. Complement system inhibitors (e.g., eculizumab). 3. Proteasome inhibitors (e.g., bortezomib). 4. Tocilizumab. 5. Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 \[CD20\] agents \[e.g., rituximab\]) within 3 months prior to randomization. 6. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Note: Other protocol-defined inclusion/exclusion criteria apply.

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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

  • Auckland City Hospital

    Grafton, Auckland, 1023, New Zealand

  • CHU Grenoble Alpes Hôpital Michallon

    La Tronche, 38700, France

  • CHU Lyon Hôpital Edouard Herriot

    Bordeaux, 32000, France

  • California Pacific Medical Center

    San Francisco, California, 94109, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

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

    Toulouse, 31400, France

  • Charite University

    Berlin, 10117, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Privada Velez Sarsfield

    Córdoba, X5000, Argentina

  • Cooperman Barnabas Medical Center

    West Orange, New Jersey, 07039, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Fundação Oswaldo Ramos - Hospital do Rim (HRIM)

    Vila Clementino, São Paulo, 04038-002, Brazil

  • Hospices Civils de Lyon - Hôpital Édouard Herriot

    Lyon, 69003, France

  • Hospital Clinic de Barcelona

    Calle Villarroel, Barcelona, 8036, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall d'Hebron

    Horta-Guinardó, Barcelona, 8035, Spain

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    Cerqueira César, São Paulo, 05403-010, Brazil

  • Hospital de Base da Faculdade de Medicina de São José do Rio Preto

    Vila São José, São José Do Rio Preto, 15090-000, Brazil

  • Hospital del Mar

    Ciutat Vella, Barcelona, 8003, Spain

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Institute for Clinical and Experimental Medicine (IKEM)

    Czechia, Praha 4, 14021, Czechia

  • Instituto de Trasplante y Alta Complejidad (ITAC)

    Cdad, Autónoma de Buenos Aires, C1425 C1425EGH, Argentina

  • Loma Linda

    San Bernardino, California, 92408, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • McGill University

    Montreal, Quebec, H3G 1A4, Canada

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of Vienna

    Spitalgasse, State of Vienna, 1090, Austria

  • Penn Medicine - Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102, Australia

  • Providence Healthcare

    Orange, California, 92868, United States

  • Royal Melbourne Hospital

    Parkville VIC, Australia, 3050, Australia

  • Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer

    Centro Histórico, Porto Alegre - RS, 90020-090, Brazil

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care

    Vancouver, British Columbia, V6T 1Z3, Canada

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 1307, Germany

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • University Hospital Basel

    Petersgraben, Basel, 4031, Switzerland

  • University of Alberta

    Edmonton, Alberta, T6G 2C8, Canada

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Nebraska

    Omaha, Nebraska, 68198-5331, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitätsspital Zürich

    Zurich, 8091, Switzerland

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Washington University

    St Louis, Missouri, 63130, United States

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