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New drug aims to stop kidney transplant rejection without antibodies

NCT ID NCT07219043

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 12 times

Summary

This study tests a drug called felzartamab in people who received a kidney transplant and later developed microvascular inflammation (MVI), a type of injury to small blood vessels in the new kidney that can lead to serious problems. The trial includes 81 participants who will receive either felzartamab or a placebo for 24 weeks, followed by an open-label phase where everyone gets the drug. Researchers will check for signs of inflammation through kidney biopsies and lab tests over about a year.

What this could mean

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

Active substance
felzartamab
What this could lead to
If successful, this could lead to a new treatment for isolated microvascular inflammation in kidney transplant recipients, potentially preserving kidney function and preventing graft loss.
What could go wrong
This is an early Phase 2 trial with only 81 participants, so results may not be conclusive. The drug may not reduce inflammation better than placebo, and there are risks from kidney biopsies and potential side effects.

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 81 people

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

Started

Jan 2026

Expected to finish

Feb 2028

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 74 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: * MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria. * Biopsy must be within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b): 1. Adequate: 10 or more non-sclerotic/evaluable glomeruli and two muscular arteries 2. Minimally Adequate: at least 7 non-sclerotic/evaluable glomeruli and one muscular artery * For participants who received any prior treatment for antibody-mediated rejection (AMR), MVI, or TCMR as outlined in Exclusion Criterion 5, the biopsy must be performed at least 6 weeks after completing (or stopping) prior treatment. * Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors). * DSA: Human leukocyte antigen (HLA) Class I and II antigen-specific DSA-negative (preformed and de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen 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. * Presence of HLA donor-specific antibodies. * Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator. * Prior AMR or 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 MVI≥2 and DSA negative status and to determine eligibility: 1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or plasma exchange (PLEX). 2. Complement system inhibitors (e.g., eculizumab). 3. Proteasome inhibitors (e.g., bortezomib). 4. The anti-interleukin-6 receptor (anti-IL-6R) tocilizumab. 5. Any B cell-depleting therapy (including anti-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 may apply.

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Conditions

The condition(s) this trial relates to.

endotheliitis

As listed by the trial registrant

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

Microvascular inflammation

How to take part

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

  1. The places running it

    45 sites in 11 countries. 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

  • Alberta Health Services (AHS) - University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2R3, Canada

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

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

    RECRUITING

    Bordeaux, 33000, France

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

    RECRUITING

    La Tronche, 38700, France

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

    RECRUITING

    Toulouse, 31400, France

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clínica Privada Vélez Sarsfield

    RECRUITING

    Córdoba, 5000, Argentina

  • Cooperman Barnabas Medical Center

    RECRUITING

    West Orange, New Jersey, 07039, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hospices Civils de Lyon - Hôpital Édouard Herriot

    RECRUITING

    Lyon, 69003, France

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, 8036, Spain

  • Hospital Del Mar

    RECRUITING

    Barcelona, 8003, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)

    RECRUITING

    São Paulo, 05403-900, Brazil

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

    RECRUITING

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

  • Hospital do Rim - Fundação Oswaldo Ramos

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Institut klinicke a experimentalni mediciny (IKEM)

    RECRUITING

    Prague, 104 21, Czechia

  • Instituto de Trasplante y Alta Complejidad (ITAC)

    RECRUITING

    Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), 1425, Argentina

  • Keck Hispital of University of Southern California (USC)

    RECRUITING

    Los Angeles, California, 90033, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92350, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medizinische Universität Wien

    RECRUITING

    Vienna, 1090, Austria

  • Penn Medicine - Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Queensland, 4102, Australia

  • Providence St. Joseph Hospital Orange

    RECRUITING

    Orange, California, 92868, United States

  • Sutter Health - California Pacific Medical Center

    RECRUITING

    San Francisco, California, 94115, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 1307, Germany

  • University of California San Fransisco (UCSF) Medical Center

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Michigan Medical Center

    RECRUITING

    Ann Arbor, Michigan, 48109-5650, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20251, Germany

  • Universitätsspital Zürich

    RECRUITING

    Zurich, 8091, Switzerland

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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