Antibody-Mediated Rejection (AMR)Phase 2NCT07613359
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
A Phase 2 study testing Mezagitamab in people with Antibody-Mediated Rejection (AMR), run by Takeda at 35 sites in 5 countries.
Trial summary
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure. AMR happens when the kidney recipient's immune system makes antibodies that attack the donor kidney. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antibody-Mediated Rejection (AMR)
- What is being tested?
- Mezagitamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 15 Oct 2026to 15 Jan 2029
- Phase
- Phase 2
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant aged 18 to 80 years.
- The participant must have a biopsy-confirmed diagnosis of active or chronic active late AMR (defined as greater than [>] 6 month after kidney transplant) without concurrent definitive TCMR (Grade 1a and above) as defined by the 2022 Banff classification.
- Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window.
- If the participant has received treatment for rejection, then the repeat biopsy and donor specific antibody (DSA) testing must have been performed at least 6 weeks after stopping the treatment.
- The participant with either human leukocyte antigen (HLA) class I and/or II DSA.
- eGFR > 30 milliliters per minute per 1.73 square meters (mL/min/1.73m^2).
Who cannot join
- The participant has blood type A, B, AB, or O (ABO) incompatible transplant.
- The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants.
- Participant likely to require renal replacement therapy within the subsequent 30 days.
- Participants who have received an anti-cluster of differentiation 38 (CD38) therapy in the last 1 year or have past history of failing to achieve AMR resolution despite treatment with an anti-CD38 therapy.
- The participant has received any previous treatment with other immunosuppressant or immunomodulatory therapy:
- Within 6 months of signing the informed consent form (ICF) as listed below:
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- Complement system inhibitors (such as, eculizumab).
- Proteasome inhibitors (such as, bortezomib).
- Interleukin-6 (IL-6)/IL-6R antibody (such as, tocilizumab).
- Anti-cluster of differentiation 20 (CD20) antibody (such as, rituximab). b) Within 6 weeks of signing the ICF as listed below:
- Intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) or plasmapheresis
- The participant has active infection with hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Participant with serious infection within 2 weeks or with opportunistic infection within 2 months prior to signing ICF. Participant with active or untreated tuberculosis, or those with high suspicion of tuberculosis are also excluded.
- History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.
- Key Note: Other protocol specified inclusion and exclusion criteria apply.
Trial locations and contacts
35 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 5 countries
United States14 sites
University of Maryland
Baltimore, Maryland, 21201
jbromberg@smail.umaryland.edu
Jonathan Bromberg
Cleveland Clinic - Cleveland
Cleveland, Ohio, 44195
augustj4@ccf.org
Joshua Augustine
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
David.Wojciechowski@UTSouthwestern.edu
David Wojciechowski
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
anup.patel@rwjbh.org
Anup Patel
UCLA University of California Los Angeles
Los Angeles, California, 90024
bunnapradist@mednet.ucla.edu
Suphamai Bunnapradist
University of Miami Hospital and Clinics
Miami, Florida, 33136
amattiazzi@med.miami.edu
Adela Mattiazzi
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
macooper@mcw.edu
Matthew Cooper
Intermountain Healthcare
Murray, Utah, 84107
sanjivanand@yahoo.com
Sanjiv Anand
NYU Langone Health - Transplant Associates
New York, New York, 10016
Aprajita.Mattoo@nyulangone.org
Aprajita Mattoo
Weill Cornell Medicine - Nephrology and Kidney Transplantation Medicine
New York, New York, 10021
dmd2001@med.cornell.edu
Darshana Dadhania
Virginia Commonwealth University (VCU) - Medical Center - Hume-Lee Transplant Center (HLTC)
Richmond, Virginia, 23298
Gaurab Gupta
Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic
San Francisco, California, 94118
anshul.x.bhalla@kp.org
Anshul Bhalla
Washington University School of Medicine
St Louis, Missouri, 63110
talhamad@wustl.edu
Tarek Alhamad
Tampa General Hospital
Tampa, Florida, 33606
lbeltran@flkidney.com
Luis Beltran
China8 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
yczhu82@gmail.com
Yichen Zhu
West China Hospital Sichuan University
Chengdu, Sichuan, 610000
yyshi_130@126.com
Yunying Shi
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangdong, 510080
wangchx@mail.sysu.edu.cn
Changxi Wang
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
rd_wangjia@zju.edu.cn
Rending Wang
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250013
docjianning_wang@yeah.net
Jianning Wang
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007
sxywn@sohu.com
Xuyong Sun
Tongji Hospital Affiliated to Tongji Medicine University
Wuhan, Hubei, 430075
gchen@tjh.tjmu.edu.cn
Gang Chen
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
xwujun126@mail.xjtu.edu.cn
Wujun Xue
Japan5 sites
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520
096-384-2111, yamanaga@kumamoto-med.jrc.or.jp
Shigeyoshi Yamanaga
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
kenta88@nagoya2.jrc.or.jp
Kenta Futamura
Niigata University Medical and Dental Hospital
Niigata, 951-8520
masa1214@med.niigata-u.ac.jp
Masayuki Tasaki
Osaka Metropolitan University Hospital
Osaka, 545-8585
uchida@omu.ac.jp
Junji Uchida
Yochomachi Clinic
Shinjuku-ku, Tokyo, 162-0055
81353122059, omotokazuya@yahoo.co.jp
Kazuya Omoto
France4 sites
CHU Bordeaux, CHU Pellegrin
Bordeaux, 33076
lionel.couzi@chu-bordeaux.fr
Lionel Couzi
Hopital Henri Mondor
Créteil, 94000
marie.matignon@aphp.fr
Marie Matignon
Hopital Edouard Herriot (HEH)
Lyon, 69003
olivier.thaunat@chu-lyon.fr
Olivier Thaunat
CHU de Toulouse - Hopital Rangueil
Toulouse
kamar.n@chu-toulouse.fr
Nassim Kamar
Germany4 sites
Kliniken Universitatsklinikum Bochum GmbH
Bochum, North Rhine-Westphalia, 44892
Andreas Schnitzbauer
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45122
Benjamin Wilde
Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen
München, 81377
Michael Fischereder
Universitaetsklinikum Muenster
Münster
Stefan Reuter
About this study
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Mezagitamab (TAK-079) in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure. AMR happens when the kidney recipient's immune system makes antibodies that attack the donor kidney. Antibodies are proteins made by the immune system to recognize foreign cells. Over time, this attack can damage kidney tissue and cause the transplant to fail. Because AMR can be serious, there is a need for treatments that are safe, work well, and are supported by good evidence.
The main aim of this study is to find out how safe mezagitamab is and how well adults with AMR tolerate it compared with placebo. A placebo looks like medicine but has no active ingredients. The study will also look at whether mezagitamab helps to control inflammation in the transplanted kidney and helps keep kidney function stable, compared with placebo.
Read more
Participants will be placed by chance in 1 of the 3 treatment groups in equal numbers. Two groups will receive mezagitamab in two different doses. One group will receive placebo. This means that out of every 3 participants, 2 will receive mezagitamab and 1 will receive placebo.
During the study, participants will visit their study clinic several times.
- Conditions
- Antibody-Mediated Rejection (AMR)
- Being tested
- Mezagitamab, Placebo
- Keywords
- Drug Therapy, TAK-079
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MezagitamabDrug
Also called TAK-079
Mezagitamab subcutaneous (SC) injection.
PlaceboDrug
Mezagitamab-matching placebo SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Mezagitamab + Placebo | Experimental | Participants will receive mezagitamab up to Week 24, followed by placebo up to Week 48, followed by an observation period up to Week 70. Receives: Drug: Mezagitamab; Drug: Placebo |
| Arm B: Mezagitamab | Experimental | Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70. Receives: Drug: Mezagitamab |
| Arm C: Placebo | Active comparator | Participants will receive placebo up to Week 48, followed by an observation period up to Week 70. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational medicinal product (IMP).
Measured: Up to Week 70
Arms A, B, and C: Number of Participants With Related TEAEs
A related AE is an AE that is considered related to the IMP. Related TEAEs are defined as related AEs with start dates at the time of or following the first exposure to IMP.
Measured: Up to Week 70
Arms A, B, and C: Number of Participants With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
Measured: Up to Week 70
Arms A, B, and C: Number of Participants With AEs of Special Interest
AEs of special interest are AEs that are considered specific to the IMP.
Measured: Up to Week 70
Arms A, B, and C: Number of Participants With AE Leading to Treatment Discontinuation
Measured: Up to Week 70
Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs
Measured: Up to Week 70
Secondary outcomes (16)
Arms A, B, and C: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Weeks 24 and 48
Achievement of biopsy-proven histological resolution of AMR activity will be assessed by the 2022 Banff classification criteria. The Banff 2022 Classification provides a standardized framework for evaluating kidney transplant biopsies using lesion scoring.
Measured: Weeks 24 and 48
Arms A, B, and C: Microvascular Inflammation (MVI) Score in Biopsy Samples at Weeks 24 and 48
MVI is an important marker of allograft loss and is defined as the sum of glomerulitis and peritubular capillaritis scores (g+ptc) on kidney histology.
Measured: Weeks 24 and 48
Arms A, B, and C: Percentage of Participants Who Achieve a MVI Score of 0 at Weeks 24 and 48
Measured: Weeks 24 and 48
Arms A, B, and C: Change From Baseline in MVI score at Weeks 24 and 48
Measured: Baseline, Weeks 24 and 48
Arms A, B, and C: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Weeks 24, 48 and 70
eGFR is a measure of kidney function calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Measured: Baseline, Weeks 24, 48 and 70
Arms A, B, and C: Change From Baseline in Donor-Derived Cell-Free DNA (dd-cfDNA) at Weeks 24, 48 and 70
dd-cfDNA are DNA fragments released from injured donor cells. It serves as a noninvasive, quantitative method that reflects allograft injury and is associated with AMR activity in kidney transplant recipients.
Measured: Baseline, Weeks 24, 48 and 70
Arms A, B, and C: Change From Baseline in Urine Protein Creatinine Ratio (UPCR) at Weeks 24, 48 and 70
UPCR is a measure of protein excretion calculated from a urine sample, as the ratio of urine protein to creatinine, and used to assess kidney function.
Measured: Baseline, Weeks 24, 48 and 70
Arm B: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 70
Measured: Week 70
Arm B: MVI Score in Biopsy Samples at Week 70
Measured: Week 70
Arm B: Percentage of Participants Who Achieve a MVI Score of 0 at Week 70
Measured: Week 70
Arm B: Change From Baseline in MVI score at Week 70
Measured: Week 70
Arms A, B, and C: Percentage of Participants With T-Cell Mediated Rejection (TCMR) by Biopsy at Weeks 24 and 48
Measured: Weeks 24 and 48
Arm B: Percentage of Participants With TCMR by Biopsy at Week 70
Measured: Week 70
Arms A and B: Serum Concentration of Mezagitamab
Measured: Pre-dose and at multiple time points post-dose up to Week 70
Arms A, B and C: Number of Participants With Anti-Drug Antibody
Measured: Pre-dose and at multiple time points post-dose up to Week 70
Arms A, B and C: Number of Participants With Neutralizing Antibody
Measured: Pre-dose and at multiple time points post-dose up to Week 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-Mediated Rejection (AMR)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613359
- Sponsor's protocol ID
- TAK-079-2002
- Other IDs
- 2026-526239-20-00, jRCT2071260091
- Status last verified
- Sep 2026
- First submitted
- 22 May 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.