Recruiting
Phase 2

Felzartamab

Sponsor:

Biogen

Code:

NCT07219043

Conditions

Microvascular Inflammation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Felzartamab

Placebo

Study Details

Brief summary:

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.

Conditions

Microvascular Inflammation

Study ID

NCT07219043

Start date

Jan 5, 2026

Status verified date

Sep, 2026

Completion date

Feb 10, 2028

Anticipated

Primary completion date

Feb 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Felzartamab

Participants will receive multiple IV doses of felzartamab.

placebo comparator: Placebo and Felzartamab

Participants will receive multiple IV doses of placebo followed by multiple doses of IV felzartamab.

Interventions

Felzartamab

Administered IV

Placebo

Administered IV

Primary outcome measure

  • Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

US Biogen Clinical Trial Center

866-633-4636clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

clinicaltrials@biogen.com

Locations

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92350

Contacts

909-558-3722

Principal Investigator:

Rafael Villicana

Keck Hispital of University of Southern California (USC)

Recruiting

Los Angeles, California, United States, 90033

Contacts

800-872-2273

Principal Investigator:

Thin Thin Maw

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

310-423-2641

Principal Investigator:

Edmund Huang

Providence St. Joseph Hospital Orange

Recruiting

Orange, California, United States, 92868

Contacts

714-771-8000

Principal Investigator:

Yasir Qazi

Sutter Health - California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94115

Contacts

415-600-1063

Principal Investigator:

Ram V. Peddi

University of California San Fransisco (UCSF) Medical Center

Recruiting

San Francisco, California, United States, 94158

Contacts

412-518-0094

Principal Investigator:

Puneet Sood

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

913-574-0084

Principal Investigator:

Diane Cibrik

University of Michigan Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48109-5650

Contacts

734-936-6381

Principal Investigator:

Mona Doshi

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

507-266-6953

Principal Investigator:

Carrie Schinstock

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

314-362-8351

Principal Investigator:

Tarek Alhamad

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

402-559-9235

Principal Investigator:

Eric Langewisch

Cooperman Barnabas Medical Center

Recruiting

West Orange, New Jersey, United States, 07039

Contacts

973-322-2146

Principal Investigator:

Anup Patel

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

919-681-2533

Principal Investigator:

Scott Sanoff

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

216-444-5383

Principal Investigator:

Emilio Poggio

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

614-293-4997

Principal Investigator:

Todd Pesavento

Penn Medicine - Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

215-614-4274

Principal Investigator:

Roy Bloom

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

615-322-6976

Principal Investigator:

Tony Langone

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

617-724-9673

Principal Investigator:

David Wojciechowski

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

713-441-6174

Principal Investigator:

Osama Gaber

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

Recruiting

Richmond, Virginia, United States, 23298

Contacts

804-828-1855

Principal Investigator:

Gaurav Gupta

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

206-598-5896

Principal Investigator:

Nicolae Leca

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

414-805-6060

Principal Investigator:

Matthew Cooper

Alberta Health Services (AHS) - University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contacts

(780) 492-2532

Principal Investigator:

Sita Gourishankar

More Information

Sponsor

Biogen

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Kidney Transplant
  • Kidney Transplant Rejection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Biogen on 2026-09-04.