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

June 4, 2026 updated by: Biogen

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with active or chronic active AMR.

The secondary objectives of this study are: Part A: To evaluate the efficacy of felzartamab compared to placebo through additional clinical endpoints; Part B: To summarize felzartamab efficacy at Week 52 in kidney transplant recipients diagnosed with active or chronic active AMR; Parts A and B: To evaluate the safety of felzartamab in kidney transplant recipients diagnosed with active or chronic AMR and to assess the pharmacokinetic (PK) profile and immunogenicity of felzartamab.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000
        • Clinica Privada Velez Sarsfield
    • Autónoma de Buenos Aires
      • Cdad, Autónoma de Buenos Aires, Argentina, C1425 C1425EGH
        • Instituto de Trasplante y Alta Complejidad (ITAC)
  • Australia
      • Woolloongabba, Australia, QLD 4102
        • Princess AleXandra Hospital
    • Australia
      • Parkville VIC, Australia, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
    • State of Vienna
      • Spitalgasse, State of Vienna, Austria, 1090
        • Medical University of Vienna
  • Brazil
    • Porto Alegre - RS
      • Centro Histórico, Porto Alegre - RS, Brazil, 90020-090
        • Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
    • São José Do Rio Preto
      • Vila São José, São José Do Rio Preto, Brazil, 15090-000
        • Hospital de Base da Faculdade de Medicina de São José do Rio Preto
    • São Paulo
      • Cerqueira César, São Paulo, Brazil, 05403-010
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
      • Vila Clementino, São Paulo, Brazil, 04038-002
        • Fundação Oswaldo Ramos - Hospital do Rim (HRIM)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University
  • Czechia
    • Praha 4
      • Czechia, Praha 4, Czechia, 14021
        • Institute for Clinical and Experimental Medicine (IKEM)
  • France
      • Bordeaux, France, 32000
        • CHU Lyon Hôpital Edouard Herriot
      • La Tronche, France, 38700
        • CHU Grenoble Alpes Hôpital Michallon
      • Lyon, France, 69003
        • Hospices Civils de Lyon - Hôpital Édouard Herriot
      • Toulouse, France, 31400
        • Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
  • Germany
      • Berlin, Germany, 10117
        • Charite University
      • Dresden, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus Dresden
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Auckland city hospital
  • Spain
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Calle Villarroel, Barcelona, Spain, 8036
        • Hospital Clínic de Barcelona
      • Ciutat Vella, Barcelona, Spain, 8003
        • Hospital del Mar
      • Horta-Guinardó, Barcelona, Spain, 8035
        • Hospital Universitario Vall d'Hebron
  • Switzerland
      • Zurich, Switzerland, 8091
        • Universitätsspital Zürich
    • Basel
      • Petersgraben, Basel, Switzerland, 4031
        • University Hospital Basel
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA
      • Orange, California, United States, 92868
        • Providence Healthcare
      • San Bernardino, California, United States, 92408
        • Loma Linda
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94109
        • California Pacific Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5331
        • University of Nebraska
    • New Jersey
      • West Orange, New Jersey, United States, 07039
        • Cooperman Barnabas Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Medicine - Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria.
  • Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
  • Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen 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.
  • Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator.

  • Treatment: Prior AMR/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 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 B cell-depleting therapy (including anti-Cluster of Differentiation 20 [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 apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Participants will receive 0.9% saline solution by intravenous infusion.
Experimental: Felzartamab
Drug: Felzartamab
Participants will receive felzartamab by intravenous infusion.
Other Names:
  • MOR202
  • HIB202
  • MOR03087
  • TJ202
  • BIIB148

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A: Microvascular Inflammation (MVI) Score
Time Frame: Week 24
Week 24
Part A: Percentage of Participants Who Achieve an MVI Score of 0
Time Frame: Week 24
Week 24
Part A: Change from Baseline in Donor-derived Cell-free DNA (dd-cfDNA)
Time Frame: Baseline, Week 24
Baseline, Week 24
Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, Week 24
Baseline, Week 24
Part B: Percentage of Participants Who Achieve BPHR
Time Frame: Weeks 24 and 52
Weeks 24 and 52
Part B: MVI Score
Time Frame: Weeks 24 and 52
Weeks 24 and 52
Part B: Percentage of Participants Who Achieve an MVI Score of 0
Time Frame: Weeks 24 and 52
Weeks 24 and 52
Part B: Change from Baseline in dd-cfDNA
Time Frame: Baseline, Weeks 24 and 52
Baseline, Weeks 24 and 52
Part B: Change from Baseline in eGFR
Time Frame: Baseline, Weeks 24 and 52
Baseline, Weeks 24 and 52
Part B: Time to All-cause Allograft Loss
Time Frame: Up to Week 52
Up to Week 52
Parts A and B: Number of Participants with Adverse Events
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Laboratory Abnormalities
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Vital Signs Abnormalities
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant ECG Abnormalities
Time Frame: From time of first dose to end of trial visit (Up to Week 52)
From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Percentage of Participants with T Cell-mediated Rejection (TCMR) by Biopsy
Time Frame: Weeks 24 and 52
Weeks 24 and 52
Parts A and B: Felzartamab Serum Concentration
Time Frame: Up to Week 52
Up to Week 52
Parts A and B: Number of Participants with Anti-drug Antibodies (ADAs) against Felzartamab
Time Frame: Baseline, up to Week 52
Baseline, up to Week 52
Part A: Biopsy-based Transcript Composite Score for AMR/MVI
Time Frame: At Week 24
At Week 24
Part B: Biopsy-based Transcript Composite Score for AMR/MVI
Time Frame: At Week 52
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 299AR301
  • 2024-519095-66-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Antibody-mediated Rejection

Clinical Trials on Felzartamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe