What this study is
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.
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.
What's being tested
- Mezagitamab
Intervention · DRUG
Mezagitamab subcutaneous (SC) injection.
- Placebo
Intervention · DRUG
Mezagitamab-matching placebo SC injection.
Study details
- 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)
- Sponsor
- Takeda
- Conditions
- Antibody-Mediated Rejection (AMR)
- Enrolling
- 36 people
- Starts
- 2026-10-27
- Est. completion
- 2029-01-15
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- 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: a) Within 6 months of signing the informed consent form (ICF) as listed below:; 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (35)
35 openUCLA University of California Los Angeles
Los Angeles, California, United States
- Contactbunnapradist@mednet.ucla.edu
- Suphamai Bunnapradist · Principal investigator
Not yet recruitingKaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic
San Francisco, California, United States
- Contactanshul.x.bhalla@kp.org
- Anshul Bhalla · Principal investigator
Not yet recruitingUniversity of Miami Hospital and Clinics
Miami, Florida, United States
- Contactamattiazzi@med.miami.edu
- Adela Mattiazzi · Principal investigator
Not yet recruitingTampa General Hospital
Tampa, Florida, United States
- Contactlbeltran@flkidney.com
- Luis Beltran · Principal investigator
Not yet recruitingUniversity of Maryland
Baltimore, Maryland, United States
- Contactjbromberg@smail.umaryland.edu
- Jonathan Bromberg · Principal investigator
RecruitingWashington University School of Medicine
St Louis, Missouri, United States
- Contacttalhamad@wustl.edu
- Tarek Alhamad · Principal investigator
Not yet recruitingCooperman Barnabas Medical Center
Livingston, New Jersey, United States
- Contactanup.patel@rwjbh.org
- Anup Patel · Principal investigator
RecruitingNYU Langone Health - Transplant Associates
New York, New York, United States
- ContactAprajita.Mattoo@nyulangone.org
- Aprajita Mattoo · Principal investigator
Not yet recruitingWeill Cornell Medicine - Nephrology and Kidney Transplantation Medicine
New York, New York, United States
- Contactdmd2001@med.cornell.edu
- Darshana Dadhania · Principal investigator
Not yet recruitingCleveland Clinic - Cleveland
Cleveland, Ohio, United States
- Contactaugustj4@ccf.org
- Joshua Augustine · Principal investigator
Not yet recruitingUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
- ContactDavid.Wojciechowski@UTSouthwestern.edu
- David Wojciechowski · Principal investigator
Not yet recruitingIntermountain Healthcare
Murray, Utah, United States
- Contactsanjivanand@yahoo.com
- Sanjiv Anand · Principal investigator
Not yet recruitingVirginia Commonwealth University (VCU) - Medical Center - Hume-Lee Transplant Center (HLTC)
Richmond, Virginia, United States
- Gaurab Gupta · Principal investigator
Not yet recruitingFroedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
- Contactmacooper@mcw.edu
- Matthew Cooper · Principal investigator
Not yet recruiting
21 sites outside the US
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
- Contactyczhu82@gmail.com
- Yichen Zhu · Principal investigator
Not yet recruitingThe First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangdong, China
- Contactwangchx@mail.sysu.edu.cn
- Changxi Wang · Principal investigator
Not yet recruitingThe Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
- Contactsxywn@sohu.com
- Xuyong Sun · Principal investigator
Not yet recruitingTongji Hospital Affiliated to Tongji Medicine University
Wuhan, Hubei, China
- Contactgchen@tjh.tjmu.edu.cn
- Gang Chen · Principal investigator
Not yet recruitingThe First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
- Contactxwujun126@mail.xjtu.edu.cn
- Wujun Xue · Principal investigator
Not yet recruitingShandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
- Contactdocjianning_wang@yeah.net
- Jianning Wang · Principal investigator
Not yet recruitingWest China Hospital Sichuan University
Chengdu, Sichuan, China
- Contactyyshi_130@126.com
- Yunying Shi · Principal investigator
Not yet recruitingThe First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
- Contactrd_wangjia@zju.edu.cn
- Rending Wang · Principal investigator
Not yet recruitingCHU Bordeaux, CHU Pellegrin
Bordeaux, France
- Contactlionel.couzi@chu-bordeaux.fr
- Lionel Couzi · Principal investigator
Not yet recruitingHopital Henri Mondor
Créteil, France
- Contactmarie.matignon@aphp.fr
- Marie Matignon · Principal investigator
Not yet recruitingHopital Edouard Herriot (HEH)
Lyon, France
- Contactolivier.thaunat@chu-lyon.fr
- Olivier Thaunat · Principal investigator
Not yet recruitingCHU de Toulouse - Hopital Rangueil
Toulouse, France
- Contactkamar.n@chu-toulouse.fr
- Nassim Kamar · Principal investigator
Not yet recruitingKliniken Universitatsklinikum Bochum GmbH
Bochum, North Rhine-Westphalia, Germany
- Andreas Schnitzbauer · Principal investigator
Not yet recruitingUniversitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
- Benjamin Wilde · Principal investigator
Not yet recruitingLudwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen
München, Germany
- Michael Fischereder · Principal investigator
Not yet recruitingUniversitaetsklinikum Muenster
Münster, Germany
- Stefan Reuter · Principal investigator
Not yet recruitingJapanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
- Contactkenta88@nagoya2.jrc.or.jp
- Kenta Futamura · Principal investigator
RecruitingJapanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
- Contact096-384-2111yamanaga@kumamoto-med.jrc.or.jp
- Shigeyoshi Yamanaga · Principal investigator
RecruitingYochomachi Clinic
Shinjuku-ku, Tokyo, Japan
- Contact81353122059omotokazuya@yahoo.co.jp
- Kazuya Omoto · Principal investigator
Not yet recruitingNiigata University Medical and Dental Hospital
Niigata, Japan
- Contactmasa1214@med.niigata-u.ac.jp
- Masayuki Tasaki · Principal investigator
Not yet recruitingOsaka Metropolitan University Hospital
Osaka, Japan
- Contactuchida@omu.ac.jp
- Junji Uchida · Principal investigator
Not yet recruiting
Study team
Sponsor
Takeda
Study ID TAK-079-2002
Study director
Study Director
Takeda
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.