Actively Recruiting
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Led by Takeda · Updated on 2026-05-13
347
Participants Needed
154
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time. In the open-label group, a small number of participants who 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
Official Title
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g or urine protein excretion (UPE) ≥ 1 g/day from 24-hour urine collection during screening (main trial only)
- Estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73m² at screening (main trial only)
- No prior exposure to anti-CD38 therapy (except specific open-label cohort participants)
- Age 18 years or older (or local legal age)
- Provided written informed consent before any trial procedures
- Diagnosis of primary IgAN confirmed by kidney biopsy within 10 years or biopsy during screening if none available
- Stable use of RAAS inhibitors (ACE-I, ARB, ERA, or MRA) for at least 12 weeks before consent, with intent to continue
- Resting blood pressure ≤ 150 mmHg systolic and ≤ 100 mmHg diastolic
- Female participants of childbearing potential must not be pregnant and have negative pregnancy tests before first dose
- Open-label cohort participants must meet additional criteria related to prior study participation and proteinuria levels
You will not qualify if you...
- Kidney biopsy showing major kidney diseases other than IgAN
- Secondary IgAN or IgA vasculitis
- Rapidly progressive glomerulonephritis with ≥ 50% eGFR loss in past 3 months
- Nephrotic syndrome with proteinuria > 3.5 g/day and low blood albumin (< 3.0 g/dL)
- Prior or planned kidney or other organ transplant
- Use of oral immunosuppressive or biologic immunomodulatory treatments in last 6 months
- Recent anti-CD20 treatment within 6-12 months with low CD19+ count or within 6 months prior to consent
- Recent high-dose corticosteroids or oral budesonide use within 4 months
- Live or live-attenuated vaccine within 4 weeks before consent or planned during trial
- Participation in other investigational drug trials within 4 weeks or 5 half-lives prior to Visit 1
- Active infections including hepatitis B, C, HIV, serious infections, recent COVID-19, opportunistic infections, or tuberculosis
- Any medical condition or serious illness that interferes with trial participation or safety
- Major surgery within 3 months before screening or recent/planned tonsillectomy
- History of cancer within 5 years except some treated skin, bladder, or cervical cancers
- Severe allergic reactions to study drug components
- COPD or asthma with low lung function (FEV1 < 50%) at screening
- Breastfeeding participants not agreeing to stop breastfeeding during treatment and 30 days after
- Participants or partners not agreeing to use highly effective contraception methods during and after treatment
- Inability or unwillingness to comply with trial procedures and use of digital tools
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 154 locations
1
UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama, United States, 35233-2110
Actively Recruiting
2
DCR Montgomery
Montgomery, Alabama, United States, 36117
Actively Recruiting
3
Panoramic Health - Southwest Kidney Institute, PLC
Surprise, Arizona, United States, 85374
Actively Recruiting
4
Panoramic Health - West Coast Kidney Institute (Fremont)
Fremont, California, United States, 94538
Actively Recruiting
5
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Actively Recruiting
6
University of California Irvine
Orange, California, United States, 92868-3201
Actively Recruiting
7
South Florida Research Institute
Lauderdale Lakes, Florida, United States, 33313-1607
Actively Recruiting
8
Bioresearch Partners
Miami, Florida, United States, 33127
Actively Recruiting
9
CTR Oakwater, LLC
Orlando, Florida, United States, 32806
Actively Recruiting
10
Bioresearch Partners
Pembroke Pines, Florida, United States, 33029
Actively Recruiting
11
Panoramic Health - Florida Kidney Physicians, LLC (Tampa)
Riverview, Florida, United States, 33578
Actively Recruiting
12
DCR Columbus
Columbus, Georgia, United States, 31904
Actively Recruiting
13
CARE Institute - Boise Kidney
Boise, Idaho, United States, 83706
Actively Recruiting
14
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States, 71101
Actively Recruiting
15
Ingham Nephrology & Hypertension, P.C.
Lansing, Michigan, United States, 48911
Actively Recruiting
16
Elixia MKC
Pontiac, Michigan, United States, 48341
Actively Recruiting
17
DCR Edina
Edina, Minnesota, United States, 55435
Actively Recruiting
18
Elixia MNA
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
19
Clinical Research Consultants a JCCT Company
Kansas City, Missouri, United States, 64111
Actively Recruiting
20
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
21
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
22
Panoramic Health - Nephrology Associates, Inc.
East Providence, Rhode Island, United States, 02914
Actively Recruiting
23
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
24
DCR - El Paso
El Paso, Texas, United States, 79902
Actively Recruiting
25
Houston Methodist Research Institute - Department of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
26
Provecta Research Network
Houston, Texas, United States, 77054
Actively Recruiting
27
Nephrology Associates of Houston PLLC
Katy, Texas, United States, 77450
Actively Recruiting
28
Sun Research Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
29
DCR San Antonio
San Antonio, Texas, United States, 78251
Actively Recruiting
30
Utah Kidney Research Institute
Salt Lake City, Utah, United States, 84115
Actively Recruiting
31
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
32
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
Actively Recruiting
33
Framingham Centro Medico
Buenos Aires, La Plata, Argentina, 1902
Actively Recruiting
34
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina, 1280
Actively Recruiting
35
Clinica Privada Velez Sarsfield
Córdoba, Argentina, X5016
Actively Recruiting
36
Core Research Group
Milton, Queensland, Australia, 4046
Actively Recruiting
37
Eastern Health
Box Hill, Victoria, Australia, 3128
Actively Recruiting
38
Western Health Sunshine Hospital
St Albans, Victoria, Australia, 3021
Actively Recruiting
39
Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2
Linz, Austria, 4040
Actively Recruiting
40
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, Austria, 1090
Actively Recruiting
41
Sheldon M. Chumir Health Centre
Calgary, Alberta, Canada, T2R 0X7
Actively Recruiting
42
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
43
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, China, 102218
Actively Recruiting
44
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Actively Recruiting
45
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
46
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
47
The Third Xiangya Hospital of Central South University Yuelu District
Changsha, Hunan, China, 410013
Actively Recruiting
48
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China, 14010
Actively Recruiting
49
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
50
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
51
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Actively Recruiting
52
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
53
Shandong University - Qilu Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
54
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
55
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
56
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
57
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
58
The Second People's Hospital of Yibin
Yibin, Sichuan, China, 644099
Actively Recruiting
59
The Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
60
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
61
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezsk Kraj, Czechia, 741 01
Actively Recruiting
62
First Faculty of Medicine Charles University
Prague, Czechia, 128 01
Actively Recruiting
63
Hospital Henri Mondor
Créteil, Paris, France, 94000
Actively Recruiting
64
CHU Bordeaux, CHU Pellegrin
Bordeaux, France, 33076
Actively Recruiting
65
CHU Limoges Service de Nephrology
Limoges, France, 87042
Actively Recruiting
66
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie
Montpellier, France, 34090
Actively Recruiting
67
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
68
Hospital Tenon
Paris, France, 75020
Actively Recruiting
69
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074
Actively Recruiting
70
Universitaetsklinikum Jena
Jena, Thuringia, Germany, 7747
Actively Recruiting
71
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, Germany, 55131
Actively Recruiting
72
The University of Hong Kong - Department of Medicine
Hong Kong, Hong Kong Island, Hong Kong
Actively Recruiting
73
Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika)
Budapest, Hungary, 1083
Actively Recruiting
74
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
75
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Italy, 25124
Actively Recruiting
76
IRCCS Ospedale Policlinico San Martino
Genoa, Italy, 16132
Actively Recruiting
77
Az Ospedaliera Universitaria Policlinico G Martino
Messina, Italy, 98122
Actively Recruiting
78
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, 20100
Actively Recruiting
79
Istituto Maugeri IRCCS Pavia
Pavia, Italy, 27100
Actively Recruiting
80
Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto
Piacenza, Italy, 29121
Actively Recruiting
81
Kasugai Municipal Hospital
Kasugai-Shi, Aichi-ken, Japan, 486-8510
Actively Recruiting
82
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan, 466-8650
Actively Recruiting
83
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan, 470-1192
Actively Recruiting
84
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba, Japan, 260-8712
Actively Recruiting
85
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
86
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan, 960-1295
Actively Recruiting
87
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
88
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
89
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan, 247-8533
Actively Recruiting
90
Toranomon Hospital Kajigaya
Kawasaki-shi, Kanagawa, Japan, 213-8587
Actively Recruiting
91
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
92
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, Japan, 981-3281
Actively Recruiting
93
Nara Medical University Hospital
Kashihara-shi, Nara, Japan, 634-8522
Actively Recruiting
94
Nara Prefecture General Medical Center
Nara, Nara, Japan, 630-8581
Actively Recruiting
95
Oita University Hospital
Yufu-shi, Oita Prefecture, Japan, 879-5593
Actively Recruiting
96
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka
Osaka, Osaka, Japan, 530-8480
Actively Recruiting
97
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, Japan, 343-8555
Actively Recruiting
98
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
99
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-0023
Actively Recruiting
100
University of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan, 409-3898
Actively Recruiting
101
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
102
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia, 25100
Actively Recruiting
103
Hospital Taiping
Taiping, Perak, Malaysia, 34000
Actively Recruiting
104
Hospital Sultan Idris Shah Serdang (Hospital Serdang)
Kajang, Selangor, Malaysia, 43000
Actively Recruiting
105
Sunway Medical Centre (SMC)
Subang Jaya, Selangor, Malaysia, 47500
Actively Recruiting
106
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
107
Leids Universitair Medisch Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
108
Sint Antonius ziekenhuis Utrecht/Nieuwegein
Nieuwegein, Netherlands, 3435CM
Actively Recruiting
109
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
110
Akershus University Hospital
Lorenskog, Akershus, Norway, 1478
Actively Recruiting
111
Sykehuset I Vestfold
Tønsberg, Vestfold, Norway, 4011
Actively Recruiting
112
Haukeland Universitetssjukehus
Bergen, Norway, 5021
Actively Recruiting
113
Sykehuset Ostfold
Grålum, Norway, 1714
Actively Recruiting
114
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger, Norway
Actively Recruiting
115
Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken
Trondheim, Norway, 7030
Actively Recruiting
116
Nowy Szpital Sp Zo.o
Gmina Świecie, Poland, 86-100
Actively Recruiting
117
SCM Sp. z o.o.
Krakow, Poland, 31-559
Actively Recruiting
118
Indywidualna Specjalistyczna Praktyka Lekarska
Lodz, Poland
Actively Recruiting
119
4th Military Clinical hospital /Polyclinic SP ZOZ
Wroclaw, Poland, 50-981
Actively Recruiting
120
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
121
Singapore General Hospital
Singapore, Singapore, 169608
Actively Recruiting
122
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
123
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
124
University Clinical Centre Maribor
Maribor, Slovenia, 2000
Actively Recruiting
125
Ajou University Hospital-Primary Research Location
Suwon, Gyeonggido, South Korea, 16499
Actively Recruiting
126
Seoul National University Bundang Hospital
Seongnam-si, Seongnam, South Korea, 13620
Actively Recruiting
127
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
128
Seoul National University Boramae Medical Center
Seoul, South Korea, 7061
Actively Recruiting
129
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 8915
Actively Recruiting
130
Universidad de Navarra - Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
131
Hospital del Mar
Barcelona, Spain, 8003
Actively Recruiting
132
Universidad de Navarra - Clinica Universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
133
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
134
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Actively Recruiting
135
Renal Medicine Linkoping University/ Linkoping University Hospital
Linköping, Sweden, SE-581 85
Actively Recruiting
136
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
137
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
138
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Actively Recruiting
139
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
140
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
141
National Taiwan University Hospital
Zhongzheng, Taiwan, 100
Actively Recruiting
142
Turgut Ozal Medical Center
Malatya, Battalgazi, Turkey (Türkiye), 44280
Actively Recruiting
143
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Şahinbey, Gaziantep, Turkey (Türkiye), 27310
Actively Recruiting
144
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Fatih, Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
145
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah
Kahramanmaraş, Onikisubat, Turkey (Türkiye), 46040
Actively Recruiting
146
Necmettin Erbakan University
Konya, Selcuklu, Turkey (Türkiye), 42280
Actively Recruiting
147
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, Greater London, United Kingdom, SE1 9RT
Actively Recruiting
148
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B95SS
Actively Recruiting
149
Kent & Canterbury Hospital, Canterbury
Canterbury, United Kingdom, CT1 3PA
Actively Recruiting
150
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Actively Recruiting
151
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
152
St George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Actively Recruiting
153
King's College Hospital
London, United Kingdom, WC2R 2LS
Actively Recruiting
154
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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