AzTrials
AzTrials

Antibody-mediated RejectionPhase 3TRANSCENDNCT06685757

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

A Phase 3 study testing Felzartamab in people with Antibody-mediated Rejection, run by Biogen at 56 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Antibody-mediated Rejection
What is being tested?
Felzartamab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
56 sitesin 12 countries
Study dates
3 Dec 2024to 1 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
  • Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or PLEX.
  • Complement system inhibitors (e.g., eculizumab).
Show all 11Show fewer
  • Proteasome inhibitors (e.g., bortezomib).
  • Tocilizumab.
  • Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 [CD20] agents [e.g., rituximab]) within 3 months prior to randomization.
  • Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.
  • Note: Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

56 sites in 12 countries.

56 sites in 12 countries

United States26 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University

    Durham, North Carolina, 27705

  • Houston Methodist

    Houston, Texas, 77030

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • University of Nebraska

    Omaha, Nebraska, 68198-5331

  • Providence Healthcare

    Orange, California, 92868

  • Penn Medicine - Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Loma Linda

    San Bernardino, California, 92408

  • California Pacific Medical Center

    San Francisco, California, 94109

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University

    St Louis, Missouri, 63130

  • Cooperman Barnabas Medical Center

    West Orange, New Jersey, 07039

Other trials in United States

Brazil4 sites

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

    Centro Histórico, Porto Alegre - RS, 90020-090

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

    Cerqueira César, São Paulo, 05403-010

  • Fundação Oswaldo Ramos - Hospital do Rim (HRIM)

    Vila Clementino, São Paulo, 04038-002

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

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

Other trials in Brazil

Canada4 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2C8

  • McGill University

    Montreal, Quebec, H3G 1A4

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

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

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

France4 sites

  • CHU Lyon Hôpital Edouard Herriot

    Bordeaux, 32000

  • CHU Grenoble Alpes Hôpital Michallon

    La Tronche, 38700

  • Hospices Civils de Lyon - Hôpital Édouard Herriot

    Lyon, 69003

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

    Toulouse, 31400

Other trials in France

Germany4 sites

  • Charite University

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 1307

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

Spain4 sites

  • Hospital Clinic de Barcelona

    Calle Villarroel, Barcelona, 8036

  • Hospital del Mar

    Ciutat Vella, Barcelona, 8003

  • Hospital Universitario Vall d'Hebron

    Horta-Guinardó, Barcelona, 8035

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Australia3 sites

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital

    Parkville VIC, Australia, 3050

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102

Other trials in Australia

Argentina2 sites

  • Instituto de Trasplante y Alta Complejidad (ITAC)

    Cdad, Autónoma de Buenos Aires, C1425 C1425EGH

  • Clinica Privada Velez Sarsfield

    Córdoba, X5000

Other trials in Argentina

Switzerland2 sites

  • University Hospital Basel

    Petersgraben, Basel, 4031

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Austria1 site

  • Medical University of Vienna

    Spitalgasse, State of Vienna, 1090

Other trials in Austria

Czechia1 site

  • Institute for Clinical and Experimental Medicine (IKEM)

    Czechia, Praha 4, 14021

Other trials in Czechia

New Zealand1 site

  • Auckland City Hospital

    Grafton, Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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.

Read more

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.
Read the 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.

Being tested
Felzartamab, Placebo
Keywords
AMR, Felzartamab, Kidney Transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FelzartamabDrug

    Also called MOR202, MOR03087, TJ202, HIB202

    Participants will receive felzartamab by intravenous infusion.

  • PlaceboDrug

    Participants will receive 0.9% saline solution by intravenous infusion.

Study groups in NCT06685757
Study groupRoleWhat they receive
FelzartamabExperimentalNot described
Receives: Drug: Felzartamab
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)

    Measured: Week 24

Secondary outcomes (19)

  1. Part A: Microvascular Inflammation (MVI) Score

    Measured: Week 24

  2. Part A: Percentage of Participants Who Achieve an MVI Score of 0

    Measured: Week 24

  3. Part A: Change from Baseline in Donor-derived Cell-free DNA (dd-cfDNA)

    Measured: Baseline, Week 24

  4. Part A: Biopsy-based Transcript Composite Score for AMR/MVI

    Measured: At Week 24

  5. Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Measured: Baseline, Week 24

  6. Part B: Percentage of Participants Who Achieve BPHR

    Measured: Weeks 24 and 52

  7. Part B: MVI Score

    Measured: Weeks 24 and 52

  8. Part B: Percentage of Participants Who Achieve an MVI Score of 0

    Measured: Weeks 24 and 52

  9. Part B: Change from Baseline in dd-cfDNA

    Measured: Baseline, Weeks 24 and 52

  10. Part B: Biopsy-based Transcript Composite Score for AMR/MVI

    Measured: At Week 52

  11. Part B: Change from Baseline in eGFR

    Measured: Baseline, Weeks 24 and 52

  12. Part B: Time to All-cause Allograft Loss

    Measured: Up to Week 52

  13. Parts A and B: Number of Participants with Adverse Events

    Measured: From time of first dose to end of trial visit (Up to Week 52)

  14. Parts A and B: Number of Participants with Clinically Significant Laboratory Abnormalities

    Measured: From time of first dose to end of trial visit (Up to Week 52)

  15. Parts A and B: Number of Participants with Clinically Significant Vital Signs Abnormalities

    Measured: From time of first dose to end of trial visit (Up to Week 52)

  16. Parts A and B: Number of Participants with Clinically Significant ECG Abnormalities

    Measured: From time of first dose to end of trial visit (Up to Week 52)

  17. Parts A and B: Percentage of Participants with T Cell-mediated Rejection (TCMR) by Biopsy

    Measured: Weeks 24 and 52

  18. Parts A and B: Felzartamab Serum Concentration

    Measured: Up to Week 52

  19. Parts A and B: Number of Participants with Anti-drug Antibodies (ADAs) against Felzartamab

    Measured: Baseline, up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start3 Dec 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06685757
Sponsor's protocol ID
299AR301
Other IDs
2024-519095-66-00
Acronym
TRANSCEND
Status last verified
Jun 2026
First submitted
11 Nov 2024
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Publications

  • Bohmig GA, Akifova A, Budde K. World Transplant Congress 2025 Highlights: Immunosuppression. Transplantation. 2026 Feb 1;110(2):e356-e362. doi: 10.1097/TP.0000000000005569. Epub 2025 Dec 23.

    PubMed 41430762

  • Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025.

    PubMed 40444214

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Felzartamab in people with Antibody-mediated Rejection, run by Biogen at 56 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Brazil, Canada, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06685757, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in