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RecruitingPhase 2

A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation

Biogen · NCT07219043

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–74 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
81
US sites recruiting
25
Study start
January 5, 2026
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.

In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI.

The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:

  • How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?

Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.

Adverse events are health problems that may or may not be caused by the study drug.

The study will be done in 2 parts as follows:

  • Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
  • In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
  • Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
  • All treatments will be given by intravenous (IV) infusion at the study site.
  • Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
  • Participants will stay in the study for about 1 year.

Being studied: Felzartamab; Placebo

Conditions: Microvascular Inflammation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 prior to randomization.
  • For participants who received any prior treatment for antibody-mediated rejection (AMR) or MVI, the biopsy must be performed after completing (or stopping) prior treatment.
  • Kidney transplant prior to Screening visit (recipients of either living or deceased donors).

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 next 30 days as determined by the Investigator.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Recruiting US locations

  • Loma Linda University Medical Center

    Loma Linda, CA 92350

    Site contact: 909-558-3722

  • Keck Hispital of University of Southern California (USC)

    Los Angeles, CA 90033

    Site contact: 800-872-2273

  • Cedars-Sinai Medical Center

    Los Angeles, CA 90048

    Site contact: 310-423-2641

  • University of California, Los Angeles

    Los Angeles, CA 90095

    Site contact: 310-794-8516

  • Providence St. Joseph Hospital Orange

    Orange, CA 92868

    Site contact: 714-771-8000

  • Sutter Health - California Pacific Medical Center

    San Francisco, CA 94115

    Site contact: 415-600-1063

  • University of California San Fransisco (UCSF) Medical Center

    San Francisco, CA 94158

    Site contact: 412-518-0094

  • University of Colorado

    Aurora, CO 80045

    Site contact: 720-848-0860

  • University of Chicago Medical Center

    Chicago, IL 60637

    Site contact: 773-702-1220

  • The University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: 913-574-0084

  • University of Michigan Medical Center

    Ann Arbor, MI 48109-5650

    Site contact: 734-936-6381

  • Mayo Clinic Rochester

    Rochester, MN 55905

    Site contact: 507-266-6953

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: 314-362-8351

  • University of Nebraska Medical Center

    Omaha, NE 68198

    Site contact: 402-559-9235

  • Cooperman Barnabas Medical Center

    West Orange, NJ 07039

    Site contact: 973-322-2146

  • Duke University Hospital

    Durham, NC 27710

    Site contact: 919-681-2533

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: 216-444-5383

  • The Ohio State University

    Columbus, OH 43210

    Site contact: 614-293-4997

  • Penn Medicine - Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: 215-614-4274

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: 615-322-6976

  • University of Texas Southwestern Medical Center

    Dallas, TX 75390

    Site contact: 617-724-9673

  • Houston Methodist Hospital

    Houston, TX 77030

    Site contact: 713-441-6174

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

    Richmond, VA 23298

    Site contact: 804-828-1855

  • University of Washington Medical Center

    Seattle, WA 98195

    Site contact: 206-598-5896

  • Medical College of Wisconsin

    Milwaukee, WI 53226

    Site contact: 414-805-6060

Study contacts (from the official record)

  • US Biogen Clinical Trial Center · 866-633-4636 · clinicaltrials@biogen.com
  • Global Biogen Clinical Trial Center · clinicaltrials@biogen.com
A Study to Learn About the Effects of Felzartamab Infusions in… (NCT07219043) | Bored Studies