Kidney DiseasePhase 3NCT06963827
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
A Phase 3 study testing Mezagitamab in people with Kidney Disease, run by Takeda at 181 sites in 26 countries.
Trial summary
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease
- 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
- 347 participants
- Where
- 181 sitesin 26 countries
- Study dates
- 15 Jul 2025to 14 Jan 2030
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this trial, participants must meet all the following criteria:
- Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).
- eGFR greater than (>)30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).
- No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).
- The participant is aged ≥ 18 years or the local legal age as applicable.
- The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated informed consent form [ICF]) and any required privacy authorization before the initiation of any clinical trial procedures.
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- Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted report must be made available for review. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.
- Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and/or angiotensin receptor blocker (ARB) or endothelin receptor antagonist (ERA) or mineralocorticoid receptor antagonist (MRA) agent for at least 12 weeks before signing the ICF with dosing at the maximally tolerated or labeled dose as determined by the investigator, with the intent to continue stable dosing during the clinical trial. Those intolerant of RAAS inhibitor therapy are potentially eligible after consultation with the medical monitor. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
- Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.
- Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin [hCG]) and on Visit 1 before first dose of trial intervention (confirmed by negative urine pregnancy test).
- Any one of the following (only applicable for participants in the open-label cohort):
- Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR >0.5 g/g or UPE >0.5 g/d calculated from a 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR >30 mL/min/1.73m^2 at screening based on the CKD-EPI formula.
- UPCR <0.8 g/g and UPE ≥0.75 and <1.0 g/day, by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR > 30 mL/min/1.73m^2 at screening based on the CKD-EPI formula.
- UPCR ≥ 0.8 g/g or UPE ≥ 1.0 g/d by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL/min/1.73m^2 at screening based on the CKD-EPI formula.
Who cannot join
- A participant who meets any of the following criteria will be excluded from participation in this trial:
- Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).
- Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).
- Diagnosis of nephrotic syndrome defined as 24-hour proteinuria >3.5 g/day and hypoalbuminemia (<3.0 grams per deciliter [g/dL]) with or without peripheral edema.
- Renal or other organ transplantation prior to or expected during the clinical trial.
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- Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory monoclonal or polyclonal antibodies) within 6 months (both B-cell and non-B-cell directed agents) before signing of the ICF.
- If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:
- The last dose was received within 6 months before the signing of the ICF.
- The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal.
- Note: Participants who have received the last dose of anti-CD20 treatment >12 months before the signing of the ICF are not excluded from clinical trial participation based on this criterion and are not required to undergo CD19+ testing.
- Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release capsules.
- The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.
- Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- The participant has had any of the following types of infections within the specified timeframes where applicable:
- Active bacterial, viral, or fungal infection (except for the common cold and onychomycosis), or any other serious infection within 2 weeks of signing the ICF. Any anti-infective course for infection must be completed at least 2 weeks before Visit 1.
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF.
- Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF.
- Active tuberculosis (TB), any history of prior active TB, or any signs or symptoms of active TB infection (including but not limited to chronic fever, chronic productive cough, night sweats, weight loss, or malnutrition) as judged by the investigator.
- For participants in European Union (EU) member states, positive or 2 indeterminant QuantiFERON results, unless there is documentation of prior complete treatment for latent TB, or participant has initiated prophylaxis based on local guidelines and in consultation with a pulmonology or infectious disease specialist prior to the first administration of IMP.
- In the opinion of the investigator, the participant is currently experiencing any medical condition that might interfere with participation in the trial (for example, significant ocular, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, infectious disease, immunodeficiency, or alcohol and drug abuse), that poses an added risk for the participant or could confound the assessment of trial results.
- In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment.
- The participant has a history of major surgery within 3 months before screening (or longer, at the discretion of the investigator); or, either has a planned tonsillectomy or underwent a tonsillectomy within 6 months before screening.
- Note: Major surgery typically requires at least 1 night in the hospital.
- 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.
- The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation.
- The participant has (1) been diagnosed with or has suspected chronic obstructive pulmonary disease (COPD) or asthma and (2) has a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal at screening.
- The participant is capable of breastfeeding but does not agree to forego breastfeeding from first dose of investigational medicinal product (IMP) through 30 days after the last dose of IMP.
- The participant is an individual with potential for pregnancy but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.
- The participant is a sexually active, non-sterilized individual who produces sperm but does not agree to use a barrier method (preferably male condom) combined with at least 1 form of highly effective contraception for any partner(s) with potential for pregnancy when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.
- In the investigator's opinion, the participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) is unwilling and/or unable to understand and fully comply with clinical trial procedures and requirements (including digital tools and applications).
Trial locations and contacts
181 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
181 sites in 26 countries
United States43 sites, 43 recruiting
- Recruiting
Renal Medicine Associates - Frenova F1
Albuquerque, New Mexico, 87109
Site Contact
Jayant Kumar
- Recruiting
Panoramic Health - Virginia Nephrology Group
Arlington, Virginia, 22205
Site Contact
Renuka Sothinathan
- Recruiting
UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama, 35233-2110
Site Contact
Dana Rizk
- Recruiting
CARE Institute - Boise Kidney
Boise, Idaho, 83706
Site Contact
Arnold Silva
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Contact
Yonatan Peleg
- Recruiting
Panoramic Health - Kidney and Hypertension Center
Cincinnati, Ohio, 45212
Site Contact
James Davis
- Recruiting
Elixia MNA
City of Saint Peters, Missouri, 63376
Site Contact
Gary Singer
- Recruiting
DCR Columbus
Columbus, Georgia, 31904
Site Contact
Tamorie Smith
- Recruiting
Dallas Renal Group
Dallas, Texas, 75230
Site Contact
Irfan Agha
- Recruiting
Panoramic Health - Southeast Kidney Associates
East Point, Georgia, 30344
Site Contact
Charmaine Ifeoma Emelife
- Recruiting
Panoramic Health - Nephrology Associates, Inc.
East Providence, Rhode Island, 02914
Site Contact
Larissa Kruger Gomes
- Recruiting
DCR Edina
Edina, Minnesota, 55435
Site Contact
Shannon Doyle
- Recruiting
DCR - El Paso
El Paso, Texas, 79902
Site Contact
Simon Rodriguez
- Recruiting
Panoramic Health - West Coast Kidney Institute (Fremont)
Fremont, California, 94538
Site Contact
Varun Chawla
- Recruiting
Houston Methodist Research Institute - Department of Medicine
Houston, Texas, 77030
Site Contact
Peter Nguyen
- Recruiting
Provecta Research Network
Houston, Texas, 77054
Site Contact
Sreedhar Mandayam
- Recruiting
Panoramic Health - Florida Kidney Physicians, LLC (Jacksonville)
Jacksonville, Florida, 32250
Site Contact
Prasanth Krish
- Recruiting
Clinical Research Consultants a JCCT Company
Kansas City, Missouri, 64111
Site Contact
Ahmed Awad
- Recruiting
Nephrology Associates of Houston PLLC
Katy, Texas, 77450
Site Contact
Syed Hussain
- Recruiting
Ingham Nephrology & Hypertension, P.C.
Lansing, Michigan, 48911
Site Contact
Brian Cousino
- Recruiting
South Florida Research Institute
Lauderdale Lakes, Florida, 33313-1607
Site Contact
Edouard Martin
- Recruiting
Academic Medical Research Institute
Los Angeles, California, 90022
Site Contact
Mohammed El-Shahwy
- Recruiting
UCLA University of California Los Angeles
Los Angeles, California, 90095
Site Contact
Anjay Rastogi
- Recruiting
Panoramic Health - Clinical Renal Associates, Ltd.
Media, Pennsylvania, 19063
Site Contact
Nathan Okechukwu
- Recruiting
Panoramic Health - Florida Kidney Physicians, LLC (Melbourne)
Melbourne, Florida, 32901
Site Contact
Claus Peter Spies
- Recruiting
Bioresearch Partners
Miami, Florida, 33127
Site Contact
Jose Miguel Cardona-Guzman
- Recruiting
DCR Montgomery
Montgomery, Alabama, 36117
Site Contact
Vinayak Ramanath
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Site Contact
Bethany Pellegrino
- Recruiting
University of California Irvine
Orange, California, 92868-3201
Site Contact
Ramy Hanna
- Recruiting
CTR Oakwater, LLC
Orlando, Florida, 32806
Site Contact
Arvind Madan
- Recruiting
Bioresearch Partners
Pembroke Pines, Florida, 33029
Site Contact
Max Benjamin
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Site Contact
Charlene Deng
- Recruiting
Elixia MKC
Pontiac, Michigan, 48341
Site Contact
Fahd Al-Saghir
- Recruiting
Panoramic Health - Florida Kidney Physicians, LLC (Tampa)
Riverview, Florida, 33578
Site Contact
Amit Augustine Johnsingh
- Recruiting
Panoramic Health - RNA of Rockford, LLC dba Rockford Nephrology Associates
Rockford, Illinois, 61107
Site Contact
Syed Mustafa Ahmed
- Recruiting
Panoramic Health - Lake Michigan Nephrology, PLC
Saint Joseph, Michigan, 49085
Site Contact
Oliver Chambers Songlingco
- Recruiting
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
Site Contact
Sanjiv Anand
- Recruiting
Sun Research Institute
San Antonio, Texas, 78215
Site Contact
Reyes Leonel
- Recruiting
DCR San Antonio
San Antonio, Texas, 78251
Site Contact
Tahira Alves
- Recruiting
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94118
Site Contact
Ali Poyan-Mehr
- Recruiting
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Site Contact
Marwan Kaskas
- Recruiting
Panoramic Health - Southwest Kidney Institute, PLC
Surprise, Arizona, 85374
Site Contact
Minesh Rajpal
- Recruiting
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103
Site Contact
Nicholas McLean
Japan20 sites, 20 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Site Contact
Yusuke Suzuki
- Recruiting
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba, 260-8712
Site Contact
Takehiko Kawaguchi
- Recruiting
University of Yamanashi Hospital
Chuo-shi, Yamanashi, 409-3898
Site Contact
Ayumu Nakashima
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Site Contact
Toshiaki Nakano
- Recruiting
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Site Contact
Kazama Junichiro
- Recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Site Contact
Takao Masaki
- Recruiting
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, 247-8533
Site Contact
Hidaka Sumi
- Recruiting
Nara Medical University Hospital
Kashihara-shi, Nara, 634-8522
Site Contact
Kazuhiko Tsuruya
- Recruiting
Kasugai Municipal Hospital
Kasugai-Shi, Aichi-ken, 486-8510
Site Contact
Yosuke Saka
- Recruiting
Toranomon Hospital Kajigaya
Kawasaki-shi, Kanagawa, 213-8587
Site Contact
Naoki Sawa
- Recruiting
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555
Site Contact
Tetsuro Takeda
- Recruiting
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Site Contact
Shoji Saito
- Recruiting
Nara Prefecture General Medical Center
Nara, Nara, 630-8581
Site Contact
Hideo Tsushima
- Recruiting
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka
Osaka, Osaka, 530-8480
Site Contact
Takeshi Matsubara
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Site Contact
Daigo Nakazawa
- Recruiting
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, 981-3281
Site Contact
Santoru Sanada
- Recruiting
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 160-0023
Site Contact
Takahito Moriyama
- Recruiting
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192
Site Contact
Naotake Tsuboi
- Recruiting
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
Site Contact
Kouichi Tamura
- Recruiting
Oita University Hospital
Yufu-shi, Oita Prefecture, 879-5593
Site Contact
Fukuda Akihiro
China19 sites, 19 recruiting
- Recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 14010
Site Contact
Zengyan Li
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Site Contact
Jicheng Lv
- Recruiting
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, 102218
Site Contact
Yuehong Li
- Recruiting
The Third Xiangya Hospital of Central South University Yuelu District
Changsha, Hunan, 410013
Site Contact
Hao Zhang
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610000
Site Contact
Ping Fu
- Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Site Contact
Guisen Li
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Site Contact
Zhiming Ye
- Recruiting
The Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang
Site Contact
Kunling Ma
- Recruiting
Shandong University - Qilu Hospital
Jinan, Shandong, 250012
Site Contact
Xiang-Dong Yang
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Site Contact
Yan Yan
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Site Contact
Liu Bicheng
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Site Contact
Xinzhong Huang
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Site Contact
Xueyan Bian
- Recruiting
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch
Shanghai, Shanghai Municipality, 200000
Site Contact
Leyi Gu
- Recruiting
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Site Contact
Jingyuan Xie
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
Site Contact
Zu-Ying Xiong
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Site Contact
Liang Wang
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
Site Contact
Bo Xu
- Recruiting
The Second People's Hospital of Yibin
Yibin, Sichuan, 644099
Site Contact
Deqiong Xie
United Kingdom10 sites, 10 recruiting
- Recruiting
Birmingham Heartlands Hospital
Birmingham, United Kingdom of Great Britain and Northern Ireland
Site Contact
Bamidele Tokunbo Ajayi
- Recruiting
Kent & Canterbury Hospital, Canterbury
Canterbury, CT1 3PA
Site Contact
Tharindra Somasinghe
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull
Site Contact
Sunil Bhandari
- Recruiting
Leicester General Hospital
Leicester
Site Contact
Chee Kay Cheung
- Recruiting
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, Greater London, SE1 9RT
Site Contact
Dimitrios-Anestis Moutzouris
- Recruiting
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Site Contact
Richard Hull
- Recruiting
King's College Hospital
London, WC2R 2LS
Site Contact
Sapna Shah
- Recruiting
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham
Site Contact
Matthew Hall
- Recruiting
Lancashire Teaching Hospital NHS Foundation Trust
Preston, PR29HT
Site Contact
Arvind Ponnusamy
- Recruiting
Northern General Hospital
Sheffield
Site Contact
Arif Khwaja
Italy8 sites, 8 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Site Contact
Gaetano La Manna
- Recruiting
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, 25124
Site Contact
Federica Mescia
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genoa, 16132
Site Contact
Francesca Viazzi
- Recruiting
Az Ospedaliera Universitaria Policlinico G Martino
Messina, 98122
Site Contact
Domenico Santoro
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20100
Site Contact
Giuseppe Castellano
- Recruiting
Istituto Maugeri IRCCS Pavia
Pavia, 27100
Site Contact
Ciro Esposito
- Recruiting
Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto
Piacenza, 29121
Site Contact
Roberto Scarpioni
- Recruiting
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Site Contact
Luigi Biancone
Spain8 sites, 8 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 8915
Site Contact
Iara Karlla Da Silva Santos
- Recruiting
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Site Contact
Laura Bueno Lopez
- Recruiting
Hospital del Mar
Barcelona, 8003
Site Contact
Eva Rodriguez Garcia
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Site Contact
Irene Agraz Pamplona
- Recruiting
Universidad de Navarra - Clinica Universidad de Navarra
Madrid, 28027
Site Contact
Jose Maria Mora Gutierrez
- Recruiting
Fundacion Jimenez Diaz
Madrid, 28040
Site Contact
Roberto Scarpioni
- Recruiting
Universidad de Navarra - Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Site Contact
Jose Maria Mora Gutierrez
- Recruiting
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Site Contact
Manuel Lopez Mendoza
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Fatih, Istanbul, 34098
Site Contact
Nurhan Seyahi
- Recruiting
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah
Kahramanmaraş, Onikisubat, 46040
Site Contact
Orcum Altunoren
- Recruiting
Erciyes University
Kayseri, Melikgazi, 38039
Site Contact
Bulent Tokgoz
- Recruiting
Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
Kocaeli
Site Contact
Necmi Eren
- Recruiting
Necmettin Erbakan University
Konya, Selcuklu, 42280
Site Contact
Kultigin Turkmen
- Recruiting
Turgut Ozal Medical Center
Malatya, Battalgazi, 44280
Site Contact
Ozkan Ulutas
- Recruiting
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Şahinbey, Gaziantep, 27310
Site Contact
Fatih Mehmet Erdur
France6 sites, 6 recruiting
- Recruiting
CHU Bordeaux, CHU Pellegrin
Bordeaux, 33076
Site Contact
Claire Rigothier
- Recruiting
Hospital Henri Mondor
Créteil, Paris, 94000
Site Contact
Vincent Audard
- Recruiting
CHU Limoges Service de Nephrology
Limoges, 87042
Site Contact
Fatouma Toure
- Recruiting
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie
Montpellier, 34090
Site Contact
Moglie Le Quintrec
- Recruiting
CHU de Nantes
Nantes, 44093
Site Contact
Simon Ville
- Recruiting
Hospital Tenon
Paris, 75020
Site Contact
Khalil Karoui
Malaysia6 sites, 6 recruiting
- Recruiting
Hospital Sultan Idris Shah Serdang (Hospital Serdang)
Kajang, Selangor, 43000
Site Contact
Li Lian Tay
- Recruiting
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Kuala Lumpur, Kuala Lumpur, 56000
Site Contact
Lydia Kamaruzaman
- Recruiting
Universiti Malaya Medical Centre (UMMC)
Kuala Lumpur, 50603
Site Contact
Soo Kun Lim
- Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100
Site Contact
Fariz Safhan Mohamad Nor
- Recruiting
Sunway Medical Centre (SMC)
Subang Jaya, Selangor, 47500
Site Contact
Rosnawati Yahya
- Recruiting
Hospital Taiping
Taiping, Perak, 34000
Site Contact
Kok Seng Teng
Norway6 sites, 6 recruiting
- Recruiting
Haukeland Universitetssjukehus
Bergen, 5021
Site Contact
Thomas Knoop
- Recruiting
Sykehuset Ostfold
Grålum, 1714
Site Contact
Dumitrescu Ioana-Elena
- Recruiting
Akershus University Hospital
Lorenskog, Akershus, 1478
Site Contact
Bartlomiej Witczak
- Recruiting
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger
Site Contact
Goransson Lasse
- Recruiting
Sykehuset I Vestfold
Tønsberg, Vestfold
Site Contact
Kjellevold Stig Arne
- Recruiting
Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken
Trondheim, 7030
Site Contact
Yngvar Haaskjold
Australia5 sites, 5 recruiting
- Recruiting
Eastern Health
Box Hill, Victoria, 3128
Site Contact
Darren Lee
- Recruiting
Monash Heath - Monash University - Monash Medical Centre
Clayton, Victoria
Site Contact
Jessica Ryan
- Recruiting
South Western Sydney Local Health District - University of New South Wales - Liverpool Hospital
Liverpool, New South Wales
Site Contact
Beata Zahorowska
- Recruiting
Core Research Group
Milton, Queensland
Site Contact
David Colquhoun
- Recruiting
Western Health Sunshine Hospital
St Albans, Victoria, 3021
Site Contact
Eugenia Pedagogos
Netherlands5 sites, 5 recruiting
- Recruiting
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
Amsterdam, North Holland, 1105 AZ
Site Contact
Marc Hilhorst
- Recruiting
Leids Universitair Medisch Center
Leiden, 2333 ZA
Site Contact
Joris Rotmans
- Recruiting
Sint Antonius ziekenhuis Utrecht/Nieuwegein
Nieuwegein, 3435CM
Site Contact
Gurbey Ocak
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Site Contact
Raphael Duivenvoorden
- Recruiting
UMC Utrecht
Utrecht, 3584 CX
Site Contact
Sabine Meijvis
South Korea5 sites, 5 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Seongnam, 13620
Site Contact
Ho-Jun Chin
- Recruiting
Seoul National University Hospital
Seoul, 3080
Site Contact
Dong Ki Kim
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
Site Contact
Seung Hyeok Han
- Recruiting
Seoul National University Boramae Medical Center
Seoul, 7061
Site Contact
Jung Pyo Lee
- Recruiting
Ajou University Hospital-Primary Research Location
Suwon, Gyeonggido, 16499
Site Contact
Inwhee Park
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807
Site Contact
Yi Wen Chiu
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City
Site Contact
Mai-Szu Wu
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Site Contact
Ming-Ju Wu
- Recruiting
China Medical University Hospital
Taichung
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Ping-Chin Lai
- Recruiting
National Taiwan University Hospital
Zhongzheng, 100
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Jenq-Wen Huang
Argentina4 sites, 4 recruiting
- Recruiting
Framingham Centro Medico
Buenos Aires, La Plata, 1902
Site Contact
Martin Mamberti
- Recruiting
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, 1280
Site Contact
Hernan Trimarchi Jurado
- Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC
Site Contact
Alejandra Smuclir Quevedo
- Recruiting
Clinica Privada Velez Sarsfield
Córdoba, X5016
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Rafael Alberto Maldonado
Poland4 sites, 4 recruiting
- Recruiting
Nowy Szpital Sp Zo.o
Gmina Świecie, 86-100
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Andrzej Brymora
- Recruiting
SCM Sp. z o.o.
Krakow, 31-559
Site Contact
Dariusz Aksamit
- Recruiting
Indywidualna Specjalistyczna Praktyka Lekarska
Lodz
Site Contact
Michal Nowicki
- Recruiting
4th Military Clinical hospital /Polyclinic SP ZOZ
Wroclaw, 50-981
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Magdalena Krajewska
Canada3 sites, 3 recruiting
- Recruiting
Sheldon M. Chumir Health Centre
Calgary, Alberta, T2R 0X7
Site Contact
Louis Girard
- Recruiting
London Health Sciences Centre
London, Ontario, N6A5A5
Site Contact
Matthew Weir
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4G 3E8
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Michelle Hladunewich
Czechia3 sites, 3 recruiting
- Recruiting
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezsk Kraj, 741 01
Site Contact
Vaclava Honova
- Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
Site Contact
Karel Krejci
- Recruiting
First Faculty of Medicine Charles University
Prague
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Vladimir Tesar
Germany3 sites, 3 recruiting
- Recruiting
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Site Contact
Claudia Seikrit
- Recruiting
Universitaetsklinikum Jena
Jena, Thuringia, 7747
Site Contact
Martin Busch
- Recruiting
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, 55131
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Julia Weinmann-Manke
Singapore3 sites, 3 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Site Contact
Jason Choo
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Site Contact
See Cheng Yeo
- Recruiting
National University Hospital
Singapore
Site Contact
Boon Wee Teo
Austria2 sites, 2 recruiting
- Recruiting
Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2
Linz, 4040
Site Contact
Alexander Moschen
- Recruiting
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, 1090
Site Contact
Rainer Oberbauer
Slovenia2 sites, 2 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Site Contact
Andreja Ales Rigler
- Recruiting
University Clinical Centre Maribor
Maribor
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Sebastjan Bevc
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong - Department of Medicine
Hong Kong, Hong Kong Island
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Sydney Chi Wai Tang
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika)
Budapest, 1083
Site Contact
Akos Petho
Sweden1 site, 1 recruiting
- Recruiting
Renal Medicine Linkoping University/ Linkoping University Hospital
Linköping
Site Contact
Annette Bruchfeld
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Site Contact
Britta George
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.
Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month.
Read more
In the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.
During the study, participants will visit their study clinic several times.
- Conditions
- Kidney Disease
- Being tested
- Mezagitamab, Placebo
- Keywords
- TAK-079, Drug Therapy
- Medical subject headings
- Kidney Diseases
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 injections administered SC.
PlaceboDrug
Mezagitamab-matching placebo injections administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Mezagitamab | Experimental | Participants will receive mezagitamab injections, subcutaneously (SC), for approximately 22 weeks. Receives: Drug: Mezagitamab |
| Placebo | Placebo comparator | Participants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks. Receives: Drug: Placebo |
| Open-label Mezagitamab | Experimental | Participants will receive mezagitamab injections, SC for approximately 22 weeks. Receives: Drug: Mezagitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Proteinuria at Week 36
Proteinuria will be assessed by urine protein to creatinine ratio (UPCR) calculated from a 24-hour urine collection.
Measured: From Baseline to Week 36
Secondary outcomes (5)
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 and 104, Respectively
Measured: From Baseline to Weeks 52 and 104
The Rate of Change in eGFR From Baseline at Week 104
The rate of change in eGFR from baseline is measured as eGFR total slope.
Measured: From Baseline to Week 104
Time From Baseline to the First Occurrence of Sustained Decline in eGFR of ≥30 Percent (%) From Baseline Over at Least 4 Weeks
Measured: From Baseline to Week 104
Time from Baseline to the First Occurrence of Any of the Pre-specified Kidney Failure Composite Assessment Criteria
The pre-specified assessment criteria will include: sustained decline in eGFR of ≥30% from baseline over at least 4 weeks; sustained eGFR <15 mL/min/1.73 m^2 over at least 4 weeks; initiation of maintenance dialysis defined as dialysis performed for at least 4 weeks; receipt of kidney transplant; or death from kidney failure. Time from baseline to first occurrence of any of the above assessment criteria would be reported.
Measured: From Baseline to Week 104
Percentage of Participants Who Achieve ≥30% Reduction From Baseline in Proteinuria at Week 104
Measured: From Baseline to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start15 Jul 2025
- Primary completion7 Sep 2028 (estimated)
- Study completion14 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 347 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
- NCT06963827
- Sponsor's protocol ID
- TAK-079-3001
- Other IDs
- 2025-520825-19-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2025
- Last updated
- 23 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.
Publications
Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
PubMed 40465397