RECRUITING Phase 3 ClinicalTrials.gov

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy

Sponsor: Takeda • ClinicalTrials.gov ID: NCT06963827

Registry updated: 2026-09-30

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Description

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. 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.

Interventions

Mezagitamab (Drug)
Mezagitamab injections administered SC.
Placebo (Drug)
Mezagitamab-matching placebo injections administered SC.

Eligibility criteria

* Inclusion Criteria: To be eligible to participate in this trial, participants must meet all the following criteria: 1. 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). 2. 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). 3. No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a). 4. The participant is aged ≥ 18 years or the local legal age as applicable. 5. 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. 6. 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. 7. 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. 8. Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic. 9. 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). 10. Any one of the following (only applicable for participants in the open-label cohort): 1. 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. 2. 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. 3. 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. * Exclusion Criteria: A participant who meets any of the following criteria will be excluded from participation in this trial: 1. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease). 2. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis. 3. Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF). 4. 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. 5. Renal or other organ transplantation prior to or expected during the clinical trial. 6. 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. 7. If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply: 1. The last dose was received within 6 months before the signing of the ICF. 2. 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. 8. 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. 9. 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. 10. 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. 11. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 12. The participant has had any of the following types of infections within the specified timeframes where applicable: 1. 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. 2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF. 3. Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF. 4. 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. 5. 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. 13. 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. 14. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment. 15. 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. 16. 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. 17. The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation. 18. 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. 19. 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. 20. 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. 21. 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. 22. 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).

Conditions

Kidney Disease

Locations

UAB Nephrology Research Clinic at Paula Building — Birmingham, Alabama, United States
DCR Montgomery — Montgomery, Alabama, United States
Panoramic Health - Southwest Kidney Institute, PLC — Surprise, Arizona, United States
Panoramic Health - West Coast Kidney Institute (Fremont) — Fremont, California, United States
Academic Medical Research Institute — Los Angeles, California, United States
UCLA University of California Los Angeles — Los Angeles, California, United States
University of California Irvine — Orange, California, United States
Panoramic Health - Florida Kidney Physicians, LLC (Jacksonville) — Jacksonville, Florida, United States
South Florida Research Institute — Lauderdale Lakes, Florida, United States
Panoramic Health - Florida Kidney Physicians, LLC (Melbourne) — Melbourne, Florida, United States
Bioresearch Partners — Miami, Florida, United States
CTR Oakwater, LLC — Orlando, Florida, United States
Bioresearch Partners — Pembroke Pines, Florida, United States
Panoramic Health - Florida Kidney Physicians, LLC (Tampa) — Riverview, Florida, United States
DCR Columbus — Columbus, Georgia, United States
Panoramic Health - Southeast Kidney Associates — East Point, Georgia, United States
CARE Institute - Boise Kidney — Boise, Idaho, United States
Panoramic Health - RNA of Rockford, LLC dba Rockford Nephrology Associates — Rockford, Illinois, United States
Northwest Louisiana Nephrology — Shreveport, Louisiana, United States
Ingham Nephrology & Hypertension, P.C. — Lansing, Michigan, United States
Elixia MKC — Pontiac, Michigan, United States
Panoramic Health - Lake Michigan Nephrology, PLC — Saint Joseph, Michigan, United States
DCR Edina — Edina, Minnesota, United States
Elixia MNA — City of Saint Peters, Missouri, United States
Clinical Research Consultants a JCCT Company — Kansas City, Missouri, United States
Renal Medicine Associates - Frenova F1 — Albuquerque, New Mexico, United States
Brookview Hills Research Associates, LLC — Winston-Salem, North Carolina, United States
Panoramic Health - Kidney and Hypertension Center — Cincinnati, Ohio, United States
Panoramic Health - Clinical Renal Associates, Ltd. — Media, Pennsylvania, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Panoramic Health - Nephrology Associates, Inc. — East Providence, Rhode Island, United States
Dallas Renal Group — Dallas, Texas, United States
DCR - El Paso — El Paso, Texas, United States
Houston Methodist Research Institute - Department of Medicine — Houston, Texas, United States
Provecta Research Network — Houston, Texas, United States
Nephrology Associates of Houston PLLC — Katy, Texas, United States
Sun Research Institute — San Antonio, Texas, United States
DCR San Antonio — San Antonio, Texas, United States
Utah Kidney Research Institute — Salt Lake City, Utah, United States
Panoramic Health - Virginia Nephrology Group — Arlington, Virginia, United States
West Virginia University — Morgantown, West Virginia, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Framingham Centro Medico — Buenos Aires, La Plata, Argentina
Hospital Britanico de Buenos Aires — Ciudad Autonoma Buenos Aires, Argentina
Clinica Privada Velez Sarsfield — Córdoba, Argentina
South Western Sydney Local Health District - University of New South Wales - Liverpool Hospital — Liverpool, New South Wales, Australia
Core Research Group — Milton, Queensland, Australia
Eastern Health — Box Hill, Victoria, Australia
Monash Heath - Monash University - Monash Medical Centre — Clayton, Victoria, Australia
Western Health Sunshine Hospital — St Albans, Victoria, Australia
Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2 — Linz, Austria
Medizinische Universitat Wien (Medical University of Vienna - Austria) — Vienna, Austria
Sheldon M. Chumir Health Centre — Calgary, Alberta, Canada
London Health Sciences Centre — London, Ontario, Canada
Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
Peking University First Hospital — Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital — Changping, Beijing Municipality, China
Zhongshan Hospital Xiamen University — Xiamen, Fujian, China
Guangdong General Hospital — Guangzhou, Guangdong, China
Peking University Shenzhen Hospital — Shenzhen, Guangdong, China
The Third Xiangya Hospital of Central South University Yuelu District — Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China
Zhongda Hospital Southeast University — Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University — Nantong, Jiangsu, China
Wuxi People's Hospital — Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
Shandong University - Qilu Hospital — Jinan, Shandong, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch — Shanghai, Shanghai Municipality, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University — Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
The Second People's Hospital of Yibin — Yibin, Sichuan, China
The Second Affiliated Hospital, Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China
Nemocnice AGEL Novy Jicin a.s — Nový Jičín, Moravskoslezsk Kraj, Czechia
Fakultni nemocnice Olomouc — Olomouc, Czechia
First Faculty of Medicine Charles University — Prague, Czechia
Hospital Henri Mondor — Créteil, Paris, France
CHU Bordeaux, CHU Pellegrin — Bordeaux, France
CHU Limoges Service de Nephrology — Limoges, France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie — Montpellier, France
CHU de Nantes — Nantes, France
Hospital Tenon — Paris, France
Uniklinik RWTH Aachen — Aachen, North Rhine-Westphalia, Germany
Universitaetsklinikum Jena — Jena, Thuringia, Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz — Mainz, Germany
The University of Hong Kong - Department of Medicine — Hong Kong, Hong Kong Island, Hong Kong
Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika) — Budapest, Hungary
IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia — Brescia, Italy
IRCCS Ospedale Policlinico San Martino — Genoa, Italy
Az Ospedaliera Universitaria Policlinico G Martino — Messina, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan, Italy
Istituto Maugeri IRCCS Pavia — Pavia, Italy
Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto — Piacenza, Italy
AOU Citta della Salute e della Scienza di Torino — Torino, Italy
Kasugai Municipal Hospital — Kasugai-Shi, Aichi-ken, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital — Nagoya, Aichi-ken, Japan
Fujita Health University Hospital — Toyoake-shi, Aichi-ken, Japan
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital — Chiba, Chiba, Japan
Kyushu University Hospital — Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital — Fukushima, Fukushima, Japan
Hiroshima University Hospital — Hiroshima, Hiroshima, Japan
Hokkaido University Hospital — Sapporo, Hokkaido, Japan
Shonan Kamakura General Hospital — Kamakura-shi, Kanagawa, Japan
Toranomon Hospital Kajigaya — Kawasaki-shi, Kanagawa, Japan
Yokohama City University Hospital — Yokohama, Kanagawa, Japan
Japan Community Health care Organization Sendai Hospital — Sendai, Miyagi, Japan
Nara Medical University Hospital — Kashihara-shi, Nara, Japan
Nara Prefecture General Medical Center — Nara, Nara, Japan
Oita University Hospital — Yufu-shi, Oita Prefecture, Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka — Osaka, Osaka, Japan
Dokkyo Medical University Saitama Medical Center — Koshigaya-shi, Saitama, Japan
Juntendo University Hospital — Bunkyo-ku, Tokyo, Japan
Tokyo Medical University Hospital — Shinjuku-Ku, Tokyo, Japan
University of Yamanashi Hospital — Chuo-shi, Yamanashi, Japan
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM)) — Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan — Kuantan, Pahang, Malaysia
Hospital Taiping — Taiping, Perak, Malaysia
Hospital Sultan Idris Shah Serdang (Hospital Serdang) — Kajang, Selangor, Malaysia
Sunway Medical Centre (SMC) — Subang Jaya, Selangor, Malaysia
Universiti Malaya Medical Centre (UMMC) — Kuala Lumpur, Malaysia
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum) — Amsterdam, North Holland, Netherlands
Leids Universitair Medisch Center — Leiden, Netherlands
Sint Antonius ziekenhuis Utrecht/Nieuwegein — Nieuwegein, Netherlands
Radboud Universitair Medisch Centrum — Nijmegen, Netherlands
UMC Utrecht — Utrecht, Netherlands
Akershus University Hospital — Lorenskog, Akershus, Norway
Sykehuset I Vestfold — Tønsberg, Vestfold, Norway
Haukeland Universitetssjukehus — Bergen, Norway
Sykehuset Ostfold — Grålum, Norway
Stavanger Universitetssjukehus - Helse Stavanger HF — Stavanger, Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken — Trondheim, Norway
Nowy Szpital Sp Zo.o — Gmina Świecie, Poland
SCM Sp. z o.o. — Krakow, Poland
Indywidualna Specjalistyczna Praktyka Lekarska — Lodz, Poland
4th Military Clinical hospital /Polyclinic SP ZOZ — Wroclaw, Poland
Singapore General Hospital — Singapore, Singapore
Tan Tock Seng Hospital — Singapore, Singapore
National University Hospital — Singapore, Singapore
University Medical Centre Ljubljana — Ljubljana, Slovenia
University Clinical Centre Maribor — Maribor, Slovenia
Ajou University Hospital-Primary Research Location — Suwon, Gyeonggido, South Korea
Seoul National University Bundang Hospital — Seongnam-si, Seongnam, South Korea
Seoul National University Hospital — Seoul, South Korea
Severance Hospital, Yonsei University Health System — Seoul, South Korea
Seoul National University Boramae Medical Center — Seoul, South Korea
Hospital Universitari Germans Trias i Pujol — Badalona, Barcelona, Spain
Hospital Universitario de Cruces — Barakaldo, Bizkaia, Spain
Universidad de Navarra - Clinica Universidad de Navarra — Pamplona, Navarre, Spain
Hospital del Mar — Barcelona, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Universidad de Navarra - Clinica Universidad de Navarra — Madrid, Spain
Fundacion Jimenez Diaz — Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS — Seville, Spain
Renal Medicine Linkoping University/ Linkoping University Hospital — Linköping, Sweden
University Hospital Zurich — Zurich, Switzerland
Kaohsiung Medical University - Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
Taipei Medical University Shuang Ho Hospital — New Taipei City, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
China Medical University Hospital — Taichung, Taiwan
National Taiwan University Hospital — Zhongzheng, Taiwan
Turgut Ozal Medical Center — Malatya, Battalgazi, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi — Şahinbey, Gaziantep, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi — Fatih, Istanbul, Turkey (Türkiye)
Erciyes University — Kayseri, Melikgazi, Turkey (Türkiye)
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah — Kahramanmaraş, Onikisubat, Turkey (Türkiye)
Necmettin Erbakan University — Konya, Selcuklu, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi — Kocaeli, Turkey (Türkiye)
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital — London, Greater London, United Kingdom
Birmingham Heartlands Hospital — Birmingham, United Kingdom
Kent & Canterbury Hospital, Canterbury — Canterbury, United Kingdom
Hull University Teaching Hospitals NHS Trust — Hull, United Kingdom
Leicester General Hospital — Leicester, United Kingdom
St George's University Hospitals NHS Foundation Trust — London, United Kingdom
King's College Hospital — London, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital — Nottingham, United Kingdom
Lancashire Teaching Hospital NHS Foundation Trust — Preston, United Kingdom
Northern General Hospital — Sheffield, United Kingdom

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