Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06685757

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

Led by Biogen · Updated on 2026-03-12

120

Participants Needed

59

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney. Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail. In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant. The main question that researchers want to answer is: • How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment? Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year * How many people have no blood vessel inflammation at these times * Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment * Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year * Changes in kidney function from the start of treatment * How many people have biopsy results showing their kidney tissue looks normal again * How long the transplanted kidney keeps working * How many participants have medical problems during the study * How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52 * How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time * How felzartamab is processed by the body * How many participants develop antibodies against felzartamab in the blood The study will be done as follows: * Participants will be screened to check if they can join the study. This will take up to 42 days. * There will be 2 parts in this study. * Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo. * Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab. * All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight. * Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.

CONDITIONS

Official Title

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-confirmed active or chronic active antibody-mediated rejection (AMR) without T-cell mediated rejection
  • Kidney transplant performed at least 6 months before screening
  • Positive for donor-specific antibodies (HLA Class I and/or II) within 3 months before randomization
Not Eligible

You will not qualify if you...

  • Blood type (ABO)-incompatible kidney transplant
  • History of multiple organ transplants, including en bloc and dual kidney transplants
  • Acute rapid decline in kidney function likely requiring dialysis within 30 days
  • Treatment for AMR or T-cell mediated rejection with certain therapies (except corticosteroids) within 3 months before randomization
  • Use of intravenous or subcutaneous immunoglobulin, plasma exchange, complement inhibitors, proteasome inhibitors, tocilizumab, B cell-depleting therapies, or investigational agents within specified timeframes before randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 59 locations

1

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

4

Providence Healthcare

Orange, California, United States, 92868

Actively Recruiting

5

Loma Linda

San Bernardino, California, United States, 92408

Actively Recruiting

6

California Pacific Medical Center

San Francisco, California, United States, 94109

Actively Recruiting

7

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

8

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

9

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

10

University of Kansas

Kansas City, Kansas, United States, 66160

Actively Recruiting

11

Tulane University Health Sciences Center

New Orleans, Louisiana, United States, 70112

Actively Recruiting

12

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

13

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

14

Washington University

St Louis, Missouri, United States, 63130

Actively Recruiting

15

University of Nebraska

Omaha, Nebraska, United States, 68198-5331

Actively Recruiting

16

Cooperman Barnabas Medical Center

West Orange, New Jersey, United States, 07039

Actively Recruiting

17

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

18

University of Cincinnati

Cincinnati, Ohio, United States, 45219

Actively Recruiting

19

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

20

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

21

Penn Medicine - Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

22

Vanderbilt University

Nashville, Tennessee, United States, 37232

Actively Recruiting

23

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

24

Houston Methodist

Houston, Texas, United States, 77030

Actively Recruiting

25

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

26

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

27

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

28

Instituto de Trasplante y Alta Complejidad (ITAC)

Cdad, Autónoma de Buenos Aires, Argentina, C1425 C1425EGH

Actively Recruiting

29

Clinica Privada Velez Sarsfield

Córdoba, Argentina, X5000

Actively Recruiting

30

Royal Melbourne Hospital

Parkville VIC, Australia, Australia, 3050

Actively Recruiting

31

Westmead Hospital

Sydney, New South Wales, Australia, 2145

Actively Recruiting

32

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

Actively Recruiting

33

Princess Alexandra Hospital

Woolloongabba, Australia, QLD 4102

Actively Recruiting

34

Medical University of Vienna

Spitalgasse, State of Vienna, Austria, 1090

Actively Recruiting

35

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

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

Actively Recruiting

36

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

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

Actively Recruiting

37

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

Cerqueira César, São Paulo, Brazil, 05403-010

Actively Recruiting

38

Fundação Oswaldo Ramos - Hospital do Rim (HRIM)

Vila Clementino, São Paulo, Brazil, 04038-002

Actively Recruiting

39

University of Alberta

Edmonton, Alberta, Canada, T6G 2C8

Actively Recruiting

40

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

41

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

Vancouver, British Columbia, Canada, V6T 1Z3

Actively Recruiting

42

McGill University

Montreal, Quebec, Canada, H3G 1A4

Actively Recruiting

43

Institute for Clinical and Experimental Medicine (IKEM)

Czechia, Praha 4, Czechia, 14021

Actively Recruiting

44

CHU Lyon Hôpital Edouard Herriot

Bordeaux, France, 32000

Actively Recruiting

45

CHU Grenoble Alpes Hôpital Michallon

La Tronche, France, 38700

Actively Recruiting

46

Hospices Civils de Lyon - Hôpital Édouard Herriot

Lyon, France, 69003

Actively Recruiting

47

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

Toulouse, France, 31400

Actively Recruiting

48

Charite University

Berlin, Germany, 10117

Actively Recruiting

49

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 1307

Actively Recruiting

50

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20246

Actively Recruiting

51

Universitätsklinikum Regensburg

Regensburg, Germany, 93053

Actively Recruiting

52

Auckland City Hospital

Grafton, Auckland, New Zealand, 1023

Actively Recruiting

53

Hospital Clinic de Barcelona

Calle Villarroel, Barcelona, Spain, 8036

Actively Recruiting

54

Hospital del Mar

Ciutat Vella, Barcelona, Spain, 8003

Actively Recruiting

55

Hospital Universitario Vall d'Hebron

Horta-Guinardó, Barcelona, Spain, 8035

Actively Recruiting

56

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 8907

Actively Recruiting

57

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Actively Recruiting

58

University Hospital Basel

Petersgraben, Basel, Switzerland, 4031

Actively Recruiting

59

Universitätsspital Zürich

Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

U

US Biogen Clinical Trial Center

CONTACT

G

Global Biogen Clinical Trial Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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