Targeting B Cells and Plasma Cells in Glomerular Disease.
Syeda Behjat Ahmad, J Ashley Jefferson
https://pubmed.ncbi.nlm.nih.gov/40465397Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06963827
A Phase 3 Study to Evaluate the Efficacy and Safety of Mezagitamab in Adults With Primary IgA Nephropathy Using Stable Background Therapy
Led by Takeda · Updated on 2026-06-02
347
Participants Needed
166
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immunoglobulin A nephropathy (IgAN) is a kidney disease caused by immune system proteins building up in the kidneys, leading to inflammation and potential kidney damage. This trial aims to evaluate how mezagitamab affects protein levels in the urine compared to a placebo in adults with primary IgAN. The study also looks at the safety and tolerability of mezagitamab, along with its ability to maintain kidney function over time. Participants will be assigned randomly to one of two groups in the main part of the study: one receiving mezagitamab injections and the other receiving placebo injections, both given under the skin. Treatment lasts about 22 weeks within each 52-week cycle, with two such cycles planned. There is also an open-label group for certain participants who have lower protein levels or reduced kidney filtering ability; they will receive mezagitamab treatment similar to the main group. Participants will have monthly check-ups and be closely monitored throughout. During the study, participants will visit the clinic multiple times for assessments including urine protein measurements, kidney function tests, and safety monitoring. The main outcome is the change in urine protein at week 36, with additional measures of kidney filtering rate and kidney failure risk tracked up to week 104. The study duration and follow-up ensure thorough observation of treatment effects and safety over two years.
CONDITIONS
Brief Title
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of primary immunoglobulin A nephropathy supported by a kidney biopsy within the last 10 years
- Urine protein-to-creatinine ratio (UPCR) 20.8 g/g or urine protein excretion 1 g/day measured by 24-hour urine collection (main trial participants)
- Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73m82 at screening (main trial participants)
- No prior treatment with anti-CD38 therapy (except specific open-label participants)
- On stable renin-angiotensin-aldosterone system inhibitor therapy at maximum tolerated or labeled dose for at least 12 weeks before enrollment
- Resting blood pressure less than or equal to 150 mmHg systolic and 100 mmHg diastolic
- Female participants of childbearing potential must not be pregnant and must have negative pregnancy tests before starting treatment
- Participants (and legally acceptable representatives) must provide signed informed consent
You will not qualify if you...
- Presence of other significant kidney diseases besides IgAN (e.g., diabetic nephropathy, lupus nephritis)
- Secondary IgAN due to other diseases like liver disease or vasculitis
- Rapidly progressive glomerulonephritis with eGFR loss of 50% or more within 3 months
- Nephrotic syndrome defined by proteinuria over 3.5 g/day and low blood albumin
- Previous or expected kidney or other organ transplant
- Use of oral immunosuppressive or biologic immunomodulatory therapies within 6 months before enrollment
- Recent anti-CD20 treatment within 6 to 12 months with low CD19+ counts
- Use of high-dose systemic corticosteroids or oral budesonide within 4 months
- Live or live-attenuated vaccination within 4 weeks before enrollment or planned during the study
- Participation in another investigational drug trial within 4 weeks or five half-lives before starting
- Active infections including hepatitis B, C, HIV, tuberculosis, or recent serious infections
- Medical conditions interfering with study participation or posing added risk
- History of major surgery within 3 months or recent tonsillectomy
- History of malignancy within 5 years except certain treated cancers
- Severe allergic reactions to study drug components
- Chronic obstructive pulmonary disease or asthma with severely reduced lung function
- Breastfeeding or unwillingness to use effective contraception during the study
- Inability or unwillingness to comply with study procedures including digital tools
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 22 weeks in each 52-week period
Participants receive mezagitamab or matching placebo injections subcutaneously to treat IgA nephropathy while continuing stable background therapy.
Weekly visits for up to 22 weeks per treatment period
Follow-up
Duration - Up to 82 weeks after treatment
Participants are monitored after treatment to assess kidney function and proteinuria changes up to 104 weeks from baseline.
Periodic visits up to Week 104
Trial Site Locations
Total: 166 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
Panoramic Health - Florida Kidney Physicians, LLC (Jacksonville)
Jacksonville, Florida, United States, 32250
Actively Recruiting
8
South Florida Research Institute
Lauderdale Lakes, Florida, United States, 33313-1607
Actively Recruiting
9
Panoramic Health - Florida Kidney Physicians, LLC (Melbourne)
Melbourne, Florida, United States, 32901
Actively Recruiting
10
Bioresearch Partners
Miami, Florida, United States, 33127
Actively Recruiting
11
CTR Oakwater, LLC
Orlando, Florida, United States, 32806
Actively Recruiting
12
Bioresearch Partners
Pembroke Pines, Florida, United States, 33029
Actively Recruiting
13
Panoramic Health - Florida Kidney Physicians, LLC (Tampa)
Riverview, Florida, United States, 33578
Actively Recruiting
14
DCR Columbus
Columbus, Georgia, United States, 31904
Actively Recruiting
15
Panoramic Health - Southeast Kidney Associates
East Point, Georgia, United States, 30344
Actively Recruiting
16
CARE Institute - Boise Kidney
Boise, Idaho, United States, 83706
Actively Recruiting
17
Panoramic Health - RNA of Rockford, LLC dba Rockford Nephrology Associates
Rockford, Illinois, United States, 61107
Actively Recruiting
18
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States, 71101
Actively Recruiting
19
Ingham Nephrology & Hypertension, P.C.
Lansing, Michigan, United States, 48911
Actively Recruiting
20
Elixia MKC
Pontiac, Michigan, United States, 48341
Actively Recruiting
21
Panoramic Health - Lake Michigan Nephrology, PLC
Saint Joseph, Michigan, United States, 49085
Actively Recruiting
22
DCR Edina
Edina, Minnesota, United States, 55435
Actively Recruiting
23
Elixia MNA
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
24
Clinical Research Consultants a JCCT Company
Kansas City, Missouri, United States, 64111
Actively Recruiting
25
Renal Medicine Associates - Frenova F1
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
26
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
27
Panoramic Health - Kidney and Hypertension Center
Cincinnati, Ohio, United States, 45212
Actively Recruiting
28
Panoramic Health - Clinical Renal Associates, Ltd.
Media, Pennsylvania, United States, 19063
Actively Recruiting
29
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
30
Panoramic Health - Nephrology Associates, Inc.
East Providence, Rhode Island, United States, 02914
Actively Recruiting
31
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
32
DCR - El Paso
El Paso, Texas, United States, 79902
Actively Recruiting
33
Houston Methodist Research Institute - Department of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
34
Provecta Research Network
Houston, Texas, United States, 77054
Actively Recruiting
35
Nephrology Associates of Houston PLLC
Katy, Texas, United States, 77450
Actively Recruiting
36
Sun Research Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
37
DCR San Antonio
San Antonio, Texas, United States, 78251
Actively Recruiting
38
Utah Kidney Research Institute
Salt Lake City, Utah, United States, 84115
Actively Recruiting
39
Panoramic Health - Virginia Nephrology Group
Arlington, Virginia, United States, 22205
Actively Recruiting
40
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
41
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
Actively Recruiting
42
Framingham Centro Medico
Buenos Aires, La Plata, Argentina, 1902
Actively Recruiting
43
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina, 1280
Actively Recruiting
44
Clinica Privada Velez Sarsfield
Córdoba, Argentina, X5016
Actively Recruiting
45
Core Research Group
Milton, Queensland, Australia, 4064
Actively Recruiting
46
Eastern Health
Box Hill, Victoria, Australia, 3128
Actively Recruiting
47
Western Health Sunshine Hospital
St Albans, Victoria, Australia, 3021
Actively Recruiting
48
Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2
Linz, Austria, 4040
Actively Recruiting
49
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, Austria, 1090
Actively Recruiting
50
Sheldon M. Chumir Health Centre
Calgary, Alberta, Canada, T2R 0X7
Actively Recruiting
51
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
52
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, China, 102218
Actively Recruiting
53
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Actively Recruiting
54
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
55
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
56
The Third Xiangya Hospital of Central South University Yuelu District
Changsha, Hunan, China, 410013
Actively Recruiting
57
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China, 14010
Actively Recruiting
58
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
59
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
60
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Actively Recruiting
61
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
62
Shandong University - Qilu Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
63
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
64
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
65
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
66
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
67
The Second People's Hospital of Yibin
Yibin, Sichuan, China, 644099
Actively Recruiting
68
The Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
69
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
70
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezsk Kraj, Czechia, 741 01
Actively Recruiting
71
First Faculty of Medicine Charles University
Prague, Czechia, 128 01
Actively Recruiting
72
Hospital Henri Mondor
Créteil, Paris, France, 94000
Actively Recruiting
73
CHU Bordeaux, CHU Pellegrin
Bordeaux, France, 33076
Actively Recruiting
74
CHU Limoges Service de Nephrology
Limoges, France, 87042
Actively Recruiting
75
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie
Montpellier, France, 34090
Actively Recruiting
76
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
77
Hospital Tenon
Paris, France, 75020
Actively Recruiting
78
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074
Actively Recruiting
79
Universitaetsklinikum Jena
Jena, Thuringia, Germany, 7747
Actively Recruiting
80
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, Germany, 55131
Actively Recruiting
81
The University of Hong Kong - Department of Medicine
Hong Kong, Hong Kong Island, Hong Kong
Actively Recruiting
82
Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika)
Budapest, Hungary, 1083
Actively Recruiting
83
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
84
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Italy, 25124
Actively Recruiting
85
IRCCS Ospedale Policlinico San Martino
Genoa, Italy, 16132
Actively Recruiting
86
Az Ospedaliera Universitaria Policlinico G Martino
Messina, Italy, 98122
Actively Recruiting
87
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, 20100
Actively Recruiting
88
Istituto Maugeri IRCCS Pavia
Pavia, Italy, 27100
Actively Recruiting
89
Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto
Piacenza, Italy, 29121
Actively Recruiting
90
Kasugai Municipal Hospital
Kasugai-Shi, Aichi-ken, Japan, 486-8510
Actively Recruiting
91
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan, 466-8650
Actively Recruiting
92
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan, 470-1192
Actively Recruiting
93
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba, Japan, 260-8712
Actively Recruiting
94
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
95
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan, 960-1295
Actively Recruiting
96
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
97
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
98
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan, 247-8533
Actively Recruiting
99
Toranomon Hospital Kajigaya
Kawasaki-shi, Kanagawa, Japan, 213-8587
Actively Recruiting
100
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
101
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, Japan, 981-3281
Actively Recruiting
102
Nara Medical University Hospital
Kashihara-shi, Nara, Japan, 634-8522
Actively Recruiting
103
Nara Prefecture General Medical Center
Nara, Nara, Japan, 630-8581
Actively Recruiting
104
Oita University Hospital
Yufu-shi, Oita Prefecture, Japan, 879-5593
Actively Recruiting
105
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka
Osaka, Osaka, Japan, 530-8480
Actively Recruiting
106
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, Japan, 343-8555
Actively Recruiting
107
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
108
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-0023
Actively Recruiting
109
University of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan, 409-3898
Actively Recruiting
110
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
111
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia, 25100
Actively Recruiting
112
Hospital Taiping
Taiping, Perak, Malaysia, 34000
Actively Recruiting
113
Hospital Sultan Idris Shah Serdang (Hospital Serdang)
Kajang, Selangor, Malaysia, 43000
Actively Recruiting
114
Sunway Medical Centre (SMC)
Subang Jaya, Selangor, Malaysia, 47500
Actively Recruiting
115
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
116
Leids Universitair Medisch Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
117
Sint Antonius ziekenhuis Utrecht/Nieuwegein
Nieuwegein, Netherlands, 3435CM
Actively Recruiting
118
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
119
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
120
Akershus University Hospital
Lorenskog, Akershus, Norway, 1478
Actively Recruiting
121
Sykehuset I Vestfold
Tønsberg, Vestfold, Norway, 4011
Actively Recruiting
122
Haukeland Universitetssjukehus
Bergen, Norway, 5021
Actively Recruiting
123
Sykehuset Ostfold
Grålum, Norway, 1714
Actively Recruiting
124
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger, Norway
Actively Recruiting
125
Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken
Trondheim, Norway, 7030
Actively Recruiting
126
Nowy Szpital Sp Zo.o
Gmina Świecie, Poland, 86-100
Actively Recruiting
127
SCM Sp. z o.o.
Krakow, Poland, 31-559
Actively Recruiting
128
Indywidualna Specjalistyczna Praktyka Lekarska
Lodz, Poland
Actively Recruiting
129
4th Military Clinical hospital /Polyclinic SP ZOZ
Wroclaw, Poland, 50-981
Actively Recruiting
130
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
131
Singapore General Hospital
Singapore, Singapore, 169608
Actively Recruiting
132
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
133
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
134
University Clinical Centre Maribor
Maribor, Slovenia, 2000
Actively Recruiting
135
Ajou University Hospital-Primary Research Location
Suwon, Gyeonggido, South Korea, 16499
Actively Recruiting
136
Seoul National University Bundang Hospital
Seongnam-si, Seongnam, South Korea, 13620
Actively Recruiting
137
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
138
Seoul National University Boramae Medical Center
Seoul, South Korea, 7061
Actively Recruiting
139
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 8915
Actively Recruiting
140
Universidad de Navarra - Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
141
Hospital del Mar
Barcelona, Spain, 8003
Actively Recruiting
142
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 8035
Actively Recruiting
143
Universidad de Navarra - Clinica Universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
144
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
145
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Actively Recruiting
146
Renal Medicine Linkoping University/ Linkoping University Hospital
Linköping, Sweden, SE-581 85
Actively Recruiting
147
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
148
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
149
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Actively Recruiting
150
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
151
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
152
National Taiwan University Hospital
Zhongzheng, Taiwan, 100
Actively Recruiting
153
Turgut Ozal Medical Center
Malatya, Battalgazi, Turkey (Türkiye), 44280
Actively Recruiting
154
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Şahinbey, Gaziantep, Turkey (Türkiye), 27310
Actively Recruiting
155
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Fatih, Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
156
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah
Kahramanmaraş, Onikisubat, Turkey (Türkiye), 46040
Actively Recruiting
157
Necmettin Erbakan University
Konya, Selcuklu, Turkey (Türkiye), 42280
Actively Recruiting
158
Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
159
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, Greater London, United Kingdom, SE1 9RT
Actively Recruiting
160
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B95SS
Actively Recruiting
161
Kent & Canterbury Hospital, Canterbury
Canterbury, United Kingdom, CT1 3PA
Actively Recruiting
162
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Actively Recruiting
163
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
164
St George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Actively Recruiting
165
King's College Hospital
London, United Kingdom, WC2R 2LS
Actively Recruiting
166
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
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Research Team
T
Takeda 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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