A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

Last updated: April 16, 2025
Sponsor: Biogen
Overall Status: Active - Recruiting

Phase

3

Condition

Nephritis

Transplant Rejection

Treatment

Felzartamab

Placebo

Clinical Study ID

NCT06685757
299AR301
2024-519095-66-00
  • Ages 18-75
  • All Genders

Study Summary

The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, asdefined by the Banff 2022 criteria.

  • Kidney transplant at least 6 months prior to Screening visit (recipients of eitherliving or deceased donors).

  • Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or IIantigen-specific DSA-positive (preformed and/or de novo DSA) as determined by thelocal laboratory's definition of positivity using single-antigen bead-based assayswithin 3 months prior to randomization.

Exclusion

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 requirerenal replacement therapy within the subsequent 30 days as determined by theInvestigator.

  • Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3months prior to randomization is excluded as listed below. Participants who receivedany of these treatments between 3 and 6 months prior to randomization must have botha 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 other investigational agent within 3 months or 5 half-lives (whichever islonger) of randomization.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Felzartamab
Phase: 3
Study Start date:
December 03, 2024
Estimated Completion Date:
June 01, 2027

Study Description

NOTE: Biogen is the Sponsor of study 299AR301.

Connect with a study center

  • Biogen West Investigational Site

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Providence Healthcare

    Orange, California 92868
    United States

    Active - Recruiting

  • California Pacific Medical Center

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Biogen West Investigational Site

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • University of Nebraska

    Omaha, Nebraska 68198-5331
    United States

    Active - Recruiting

  • Biogen West Investigational Site

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Cooperman Barnabas Medical Cent

    West Orange, New Jersey 07039
    United States

    Active - Recruiting

  • Cooperman Barnabas Medical Center

    West Orange, New Jersey 07039
    United States

    Active - Recruiting

  • Biogen West Investigational Site

    Columbus, Ohio 43201
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Penn Medicine - Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Biogen West Investigational Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Biogen West Investigational Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Biogen West Investigational Site

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Biogen West Investigational Site

    Madison, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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