Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

June 1, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

Study Overview

Status

Completed

Conditions

Immunoglobulin A Nephropathy

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q 4 weeks compared to placebo in patients with IgAN. The primary objective is to compare the relative change from baseline in the urinary protein to creatinine ratio (uPCR) in 24-hour urine collections, after 9 months of treatment. The key secondary objective is to compare the annualized rate of change from baseline (slope) of estimated glomerular filtration rate (eGFR) after approximately 24 months of treatment. There will be one main cohort comprised of approximately 450 subjects with source-verified biopsy-confirmed IgAN and eGFR ≥ 30 mL/min/1.73 m^2. An additional exploratory cohort will be comprised of up to 20 subjects with source-verified biopsy confirmed IgAN and eGFR of 20 to < 29 mL/min/1.73 m^2.

Study Type

Interventional

Enrollment (Actual)

530

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1280AEB
    - Hospital Britanico de Buenos Aires - Site #800
  - Buenos Aires, Argentina, C1425
    - Maffei Centro Medico - Site #802
  - Córdoba, Argentina, X5016LIG
    - Clinica Privada Velez Sarsfield - Nephrology and Transplantation Service - Site #801
  - Junín, Argentina, 7023
    - Centro de Salud Renal Junin S.R.L. - Site #803
Australia
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australia, 2605
    - Canberra Hospital - Site #3
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Site #13
  - Kogarah, New South Wales, Australia, 2217
    - St. George Hospital - Site #14
  - Liverpool, New South Wales, Australia, 2170
    - University of New South Wales (UNSW) - Liverpool Hosp - Site #11
  - New Lambton Heights, New South Wales, Australia, 2305
    - John Hunter Hospital - Site #5
  - Randwick, New South Wales, Australia, 2031
    - Prince of Wales Hospital - Site #2
  - Saint Leonards, New South Wales, Australia, 2065
    - Royal North Shore Hospital - Site #6
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital - Site #12
  - Bedford Park, South Australia, Australia, 5042
    - Flinders Medical Centre - Site #9
- Tasmania
  - Launceston, Tasmania, Australia, 7250
    - Launceston General Hospital - Site #8
- Victoria
  - Fitzroy, Victoria, Australia, 3065
    - The University of Melbourne - St. Vincent's Hospital Melbourne (SVHM) - Site #1
  - St Albans, Victoria, Australia, 3021
    - Western Health Sunshine Hospital - Site #10
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital (FSH) - Site #4
  - Nedlands, Western Australia, Australia, 6009
    - Sir Charles Gairdner Hospital - Site #7
Belgium
- - Brussels, Belgium, 1070
    - Hopital Erasme - Site #402
  - Genk, Belgium, 3600
    - UZ Leuven Campus Gasthuisberg - Site #401
  - Genk, Belgium, 3600
    - Ziekenhuis Oost Limburg Genk ZOL - Site #405
  - Ghent, Belgium, 9000
    - AZ Sint Lucas - Site #403
  - Liège, Belgium, 4000
    - CHR de la Citadelle - Site #400
Brazil
- - Rio de Janeiro, Brazil, 20550-010
    - Universidade estadual do Rio de Janeiro - Site #831
- Ceará
  - Fortaleza, Ceará, Brazil, 60441750
    - Universidade Federal do CearClinic Pro-nefron - Site #827
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 40415-065
    - Clinica Senhor do Bonfim Ltda CSB - Monte Serrat - Site #826
- Pernambuco
  - Recife, Pernambuco, Brazil, 50670-901
    - Recife - Site #820
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
    - Santa Casa de Misericordia - Porto Alegre - Site #824
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre HCPA - Site #828
- Santa Catarina
  - Joinville, Santa Catarina, Brazil, 89227-680
    - Fundacao Pro Rim - Site #821
- São Paulo
  - Santo André, São Paulo, Brazil, 09090-790
    - Centro de Pesquisa Medica Praxis - Site #825
  - São José do Rio Preto, São Paulo, Brazil, 15090-000
    - Faculdade de Medicina de Sao Jose do Rio Preto - SP FAMERP - Hospital de Base HB - Site #822
  - São Paulo, São Paulo, Brazil, 01246-903
    - Universidade de Sao Paulo (USP) - Faculdade de Medicina (FMUSP) - Site #823
  - São Paulo, São Paulo, Brazil, 04038-002
    - Universidade Federal de Sao Paulo - Escola Paulista de Medicina EPM - Hospital do Rim e Hipertensao HRIM - Site #830
Canada
- Alberta
  - Calgary, Alberta, Canada, T2R 0X7
    - University of Calgary - Health Research Innovation Centre: Sheldon Chumir Health Centre - Site #300
- Ontario
  - Hamilton, Ontario, Canada, L8N 4A6
    - St. Joseph's Healthcare Hamilton - Site #307
  - Kitchener, Ontario, Canada, N2H 5ZB
    - Clinical Research Solutions Inc. - Site #301
  - Oshawa, Ontario, Canada, L1G 2B9
    - Lakeridge Health Oshawa - Site #303
  - Scarborough Village, Ontario, Canada, M1H 3G4
    - OTT Healthcare Inc. - Site #305
  - Toronto, Ontario, Canada, M4C 5T2
    - Office of Stephen S. Chow, MD - Site #306
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne - Site #302
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre - Site #304
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100029
    - Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH) - Site #36
  - Beijing, Beijing Municipality, China, 100033
    - Peking University People's Hospital - Site #32
  - Beijing, Beijing Municipality, China, 100034
    - Peking University First Hospital - Site #20
  - Beijing, Beijing Municipality, China, 102206
    - Peking University International Hospital - Site #34
  - Beijing, Beijing Municipality, China, 102218
    - Beijing Tsinghua Changgung Hospital - Site #33
- Fujian
  - Xiamen, Fujian, China, 361004
    - Xiamen University - Zhongshan Hospital - Site #42
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - Sun Yat-sen Memorial Hospital - Site #39
  - Guangzhou, Guangdong, China, 510080
    - The First Affiliated Hospital, Sun Yat - sen University - Site #40
  - Guangzhou, Guangdong, China, 510120
    - The First Affiliated Hospital Of Guangzhou Medical University - Site #28
  - Shenzhen, Guangdong, China, 518036
    - Peking University Shenzhen Hospital - Site #43
- Guangxi
  - Liuzhou, Guangxi, China, 545027
    - Liuzhou Workers Hospital - Site #35
  - Nanning, Guangxi, China, 530016
    - The Peoples Hospital of Guangxi zhuang Autonomous Region - Site #27
- Hubei
  - Wuhan, Hubei, China, 430060
    - Renmin Hospital of Wuhan University - Site #24
- Hunan
  - Changsha, Hunan, China, 410011
    - The Second Xiangya Hospital of Central South University - Site #44
- Inner Mongolia Proviance
  - Baotou, Inner Mongolia Proviance, China, 14010
    - The First Affiliated Hospital of Baotou Medical University - Site #29
- Jiangsu
  - Wuxi, Jiangsu, China, 214023
    - Wuxi Peoples' Hospital affiliated to Nanjing Medical University - Site #30
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - The First Affiliated Hospital of Nanchang University - Site #22
  - Pingxiang, Jiangxi, China, 750004
    - Jiangxi Pingxiang Peoples' Hospital - Site #21
- Shaanxi
  - Xi'an, Shaanxi, China, 710061
    - The First Affiliated Hospital of Xi'an Jiaotong University - Site #31
  - Xi'an, Shaanxi, China, 710077
    - The First Affiliated Hospital of Xi'an Medical College - Site #23
- Shandong
  - Jinan, Shandong, China, 250013
    - The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) - Site #26
  - Yantai, Shandong, China, 264099
    - Yantai Yuhuangding Hospital - Site #41
- Sichuan
  - Chengdu, Sichuan, China, 610072
    - Sichuan Provincial Peoples Hospital - Site #38
  - Yibin, Sichuan, China, 644002
    - Yibin Second Peoples Hospital - Site #25
- Zhejiang
  - Hangzhou, Zhejiang, China, 310014
    - Zhejiang Provincial People's Hospital - Site #37
Croatia
- - Osijek, Croatia, 31000
    - University Hospital Center Osijek - Site #410
  - Split, Croatia, 21000
    - University Hospital Center Split - Site #413
  - Zagreb, Croatia, 10000
    - Klinicka Bolnica Dubrava (KBD) (Clinical Hospital Dubrava) - Site #411
  - Zagreb, Croatia, 10000
    - University Hospital Merkur - Site #414
Czechia
- - Prague, Czechia, 12808
    - Vseobecna fakultni nemocnice v Praze - Site #420
France
- Aquitaine
  - Bordeaux, Aquitaine, France, 33076
    - Hopital Pellegrin - Site #431
- Auvergne
  - Clermont-Ferrand, Auvergne, France, 63003
    - CHU Clermont-Ferrant-Gabriel Montpied - Site #443
  - Clermont-Ferrand, Auvergne, France, 443
    - CHU Clermont-Ferrant-Gabriel Montpied - Site #443
- Auvergne-Rhône-Alpes
  - Grenoble, Auvergne-Rhône-Alpes, France, 38043
    - CHU de Grenoble Alpes - Hopital Nord Michallon - Site #433
- Champagne-Ardenne
  - Reims, Champagne-Ardenne, France, 51092
    - CHU de Reims Hopital Maison Blanche - Site #442
- Gard
  - Nîmes, Gard, France, 30900
    - Centre Hospitalier Universitaire de Nimes CHU - Hopital Universitaire Caremeau - Site #430
- Haut-Rhin
  - Mulhouse, Haut-Rhin, France, 68100
    - Hopital Emile Muller - Site #438
- Hauts-de-France
  - Amiens, Hauts-de-France, France, 80054
    - CHU Amiens-Picardie Nephrology Dialysis Transplantation - Site #440
- Loire-Atlantique
  - Nantes, Loire-Atlantique, France, 44093
    - CHU Hotel Dieu, Nephrologie - Immunologie clinique - Transplantation - Site #432
- New Aquitaine
  - Limoges, New Aquitaine, France, 87000
    - CH Limoges - Site #439
- Pays de la Loire Region
  - Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42270
    - Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord - Site #434
- Provence-Alpes-Côte d'Azur Region
  - Avignon, Provence-Alpes-Côte d'Azur Region, France, 84092
    - Centre Hospitalier Henri Duffaut - Site #441
  - Marseille, Provence-Alpes-Côte d'Azur Region, France, 13385
    - Hopital La Conception Centre de Nephrologie et de Transplantation Renal - Site #437
- Île-de-France Region
  - Créteil, Île-de-France Region, France, 94010
    - Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor) - Site #436
  - Paris, Île-de-France Region, France, 1155
    - Hopital de Tenon Sorbonne Universite - Site #435
Germany
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60431
    - Agaplesion Markus Krankenhaus - Site #457
- North Rhine-Westphalia
  - Düsseldorf, North Rhine-Westphalia, Germany, 40210
    - DaVita Clinical Research Germany GmbH - Site #456
- Rhineland-Palatinate
  - Mainz, Rhineland-Palatinate, Germany, 55131
    - Universitaetsmedizin Mainz - Site #455
- Saxony
  - Dresden, Saxony, Germany, 1307
    - Universitaetsklinikum Carl Gustav Carus - Site #450
Greece
- - Athens, Greece, 11527
    - Hippokration General Hospital of Athens, Nephrology Clinic - Site #475
  - Athens, Greece, 11527
    - Hippokration General Hospital of Athens, Nephrology Clinical - Site #475
  - Heraklion, Greece, 71110
    - Nephrology Department, University General Hospital of Heraklion - Site #472
  - Ioannina, Greece, 45500
    - University Hospital of Ioannina (UHI) - Nephrology Clinic - Site #471
  - Larissa, Greece, 41110
    - University of Thessaly, Nephrology Clinic - Site #474
  - Thessaloniki, Greece, 54642
    - Aristotle University of Thessaloniki (AUTH) - Hippokration Hospital - Site #470
  - Thessaloniki, Greece, 57010
    - Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou) - Site #473
Hong Kong
- - Hong Kong, Hong Kong, 999077
    - Queen Mary Hospital - Site #60
  - Hong Kong, Hong Kong, 999077
    - Tung Wah Hospital - Site #61
  - Kowloon, Hong Kong, 999077
    - Princess Margaret Hospital - Site #62
  - Shatin, Hong Kong, 999077
    - Prince of Wales Hospital - Site #63
  - Tsuen Wan, Hong Kong, 999077
    - Yan Chai Hospital - Site #64
Hungary
- Baranya
  - Pécs, Baranya, Hungary, 7624
    - Pecsi Tudomanyegyetem, Altalanos Orvostudomanyi KarKlinikai Kozpont II - Site #482
- Somogy County
  - Kaposvár, Somogy County, Hungary, 7400
    - Somogy Megyei Kaposi Mor Oktatokorhaz - Site #481
India
- Gujarat
  - Ahmedabad, Gujarat, India, 382421
    - Kusum Dhirajlal Hospital - Site #73
  - Nadiād, Gujarat, India, 387001
    - Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital) - Site #70
- Karnataka
  - Bengaluru, Karnataka, India, 560054
    - M.S. Ramaiah Memorial Hospital - Site #72
  - Bengaluru, Karnataka, India, 560099
    - Mazumdar Shaw Medical Centre - A unit of Narayana Health - Site #87
  - Manipal, Karnataka, India, 576104
    - Manipal University - Kasturba Medical College - Site #79
- Kerala
  - Kozhikode, Kerala, India, 673008
    - Government Medical College - Site #71
  - Thiruvananthapuram, Kerala, India, 695011
    - Government Medical College Thiruvananthapuram - Site #74
- Maharashtra
  - Aurangabad, Maharashtra, India, 431003
    - Mahatma Gandhi Mission Institute of Health Scienes MGMIHS - Mahatma Gandhi Mission MGM Medical Centre Research Institute - Aurangabad - Site #82
  - Pune, Maharashtra, India, 411057
    - Life Point Multispecialty Hospital - Site #84
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110060
    - Sir Ganga Ram Hospital - Site #75
- Punjab
  - Chandigarh, Punjab, India, 160012
    - Postgraduate Institute of Medical Education Research PGIMER - Site #77
- Tamil Nadu
  - Vellore, Tamil Nadu, India, 632004
    - Christian Medical College & Hospital (CMCH) - Vellore - Site #80
- Telangana
  - Hyderabad, Telangana, India, 500012
    - Osmania General Hospital (OGH) - Site #78
  - Hyderabad, Telangana, India, 500082
    - Nizams Institute of Medical Sciences NIMS - Site #81
- Uttar Pradesh
  - Lucknow, Uttar Pradesh, India, 226014
    - Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) - Site #76
Israel
- - Ashkelon, Israel, 7830604
    - The Barzilai Medical Center (The Ashkelon Hospital) - Site #494
  - Haifa, Israel, 3436212
    - Technion-Israel Institute of Technology - The Lady Davis Carmel Medical Center (LDCMC) - Institute of Nephrology and Hypertension - Site #491
  - Jerusalem, Israel, 91031
    - Shaare Zedek Medical Center (SZMC) - Site #492
  - Kfar Saba, Israel, 44281
    - Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital) - Site #490
  - Nahariya, Israel, 22100
    - Galilee Medical Center (Western Galilee Hospital) - Site #495
  - Petah Tikva, Israel, 49100
    - Rabin Medical Center - Institute of Nephrology and Hypertension - Diabetic Nephropathy Clinic - Site #493
Italy
- - Bologna, Italy, 40138
    - IRCCS Azienda Ospedaliero-Universitaria Policlinico Sant Orsola - Site #512
  - Brescia, Italy, 25123
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Site #504
  - Florence, Italy, 50134
    - Azienda Ospedaliero-Universitaria Careggi Firenze - Site #500
  - Florence, Italy, 50143
    - Ospedale San Giovanni di Dio - Site #506
  - Genova, Italy, 16132
    - Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino - Site #503
  - Messina, Italy, 98122
    - AOU Gaetano Martino di Messina U.O.C., Nefrologia e Dialisi - Site #502
  - Messina, Italy, 98122
    - AOU Gaetano Martino de Messina U.O.C., Nefrologia e Dialisi - Site #502
  - Milan, Italy, 20122
    - Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Site #513
  - Naples, Italy, 80131
    - Campania Luigi Vanvitelli - Site #510
  - Pavia, Italy, 27100
    - Fondazione Maugeri - Site #509
  - Piacenza, Italy, 29121
    - AUSL Hospital Guglielmo da Saliceto - Site #507
  - Roma, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site #501
  - Vicenza, Italy, 36100
    - ULSS 6 Vicenza - Ospedale San Bortolo di Vicenza - Site #505
  - Viterbo, Italy, 1100
    - Ospedale di Belcolle Viterbo - Site #514
Japan
- - Chiba, Japan, 260-8712
    - NHO Chibahigashi National Hospital - Site #700
  - Fukuoka, Japan, 812-8582
    - Kyushu University Hospital (KUH) - Site #703
  - Fukuoka, Japan, 814-0180
    - Fukuoka University - Fukuoka University Hospital - Site #722
  - Miyazaki, Japan, 889-1692
    - University of Miyazaki Hospital - Site #716
  - Nagasaki, Japan, 852-8501
    - Nagasaki University Hospital - Site #720
  - Niigata, Japan, 951-8520
    - Niigata University Medical & Dental Hospital - Site #711
  - Okayama, Japan, 700-8558
    - Okayama University Hospital - Site #701
  - Osaka, Japan, 558-8558
    - Osaka General Medical Center - Site #721
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 466-8560
    - Nagoya University Hospital - Site #705
  - Toyoake, Aichi-ken, Japan, 470-1192
    - Fujita Health University Hospital - Site #709
- Chiba
  - Urayasu, Chiba, Japan, 279-002
    - Juntendo University - Urayasu Hospital - Site #707
- Fukuoka
  - Kurume, Fukuoka, Japan, 830-0011
    - Kurume University Hospital - Site #725
- Hyōgo
  - Amagasaki, Hyōgo, Japan, 660-8550
    - Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) - Site #723
  - Kobe, Hyōgo, Japan, 650-0017
    - Kobe University Hospital - Site #724
- Ibaraki
  - Tsukuba, Ibaraki, Japan, 305-8576
    - University of Tsukuba Hospital - Site #708
- Ishikawa-ken
  - Kanazawa, Ishikawa-ken, Japan, 920-8641
    - Kanazawa University Hospital - Site #702
- Kanagawa
  - Kawasaki, Kanagawa, Japan, 213-8587
    - Toranomon Hospital Kajigaya - Site #714
  - Sagamihara, Kanagawa, Japan, 252-0375
    - Kitasato University Hospital - Site #729
- Miyagi
  - Sendai, Miyagi, Japan, 983-8512
    - Tohoku Medical and Pharmaceutical University Hospital - Site #718
- Nara
  - Kashihara, Nara, Japan, 634-8522
    - Nara Medical University Hospital - Site #713
- Nerima-ku
  - Tokyo, Nerima-ku, Japan, 177-8521
    - Juntendo University Nerima Hospital - Site #727
- Oita Prefecture
  - Yufu, Oita Prefecture, Japan, 879-5593
    - Oita University Hospital - Site #717
  - Yufu, Oita Prefecture, Japan, 879-5593
    - Otia University Hospital - Site #717
- Osaka
  - Suita, Osaka, Japan, 565-0871
    - Osaka University Hospital - Site #719
- Shizuoka
  - Hamamatsu, Shizuoka, Japan, 431-3192
    - Hamamatsu University Hospital - Site #704
- Tochigi
  - Ashikaga, Tochigi, Japan, 326-0843
    - Japanese Red Cross Ashikaga Hospital - Site #726
- Tokyo
  - Bunkyō-Ku, Tokyo, Japan, 113-8431
    - Juntendo University Hospital - Site #715
  - Minato-Ku, Tokyo, Japan, 105-8471
    - The Jikei University Hospital - Site #712
  - Shinjuku-Ku, Tokyo, Japan, 160-0023
    - Tokyo Medical University Hospital - Site #728
  - Shinjuku-Ku, Tokyo, Japan, 162-8666
    - Tokyo Women's Medical University Hospital - Site #710
  - tabashi City, Tokyo, Japan, 173-8606
    - Teikyo University Hospital - Site #706
Malaysia
- Kuala Lumpur
  - Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
    - Hospital Kuala Lumpur - Site #123
  - Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
    - Hospital Canselor Tuanku Muhriz UKM - Site #125
  - Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
    - University Malaya Medical Centre - Site #121
- Negeri Sembilan
  - Seremban, Negeri Sembilan, Malaysia, 70300
    - Hospital Tuanku Ja'afar - Site #122
- Pahang
  - Kuantan, Pahang, Malaysia, 25100
    - Hospital Tengku Ampuan Afzan - Site #120
- Perak
  - Ipoh, Perak, Malaysia, 30450
    - Hospital Raja Permaisuri Bainun - Site #124
- Selangor
  - Petaling Jaya, Selangor, Malaysia, 47150
    - Sunway Medical Centre (SMC) - Site #126
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Amsterdam UMC - Site #522
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6500 HB
    - Radboud Universitair Medisch Centrum - Site #520
- Limburg
  - Maastricht, Limburg, Netherlands, 6229 HX
    - Maastricht University Medical Center (MUMC) - Site #523
- South Holland
  - Gouda, South Holland, Netherlands, 2803 HH
    - Groene Hart Ziekenhuis, Ioc, Bleuland - Site #521
Philippines
- - Manila, Philippines, 1015
    - University of Santo Tomas Hospital - Site #130
  - Quezon, Philippines, 1101
    - National Kidney Institute - Site #132
  - Quezon, Philippines, 1112
    - St. Luke's Medical Center - Quezon City - Site #131
Poland
- Bialystok
  - Bialystok, Bialystok, Poland, 15-276
    - Uniw. Szp. Kliniczny w Bialymstoku, 2nd Department of Nephrology and Hypertension with Dialysis Unit - Site #531
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-688
    - Szpital Uniwersytecki w Krakowie - Site #533
- Malopotskie
  - Krakow, Malopotskie, Poland, 31-513
    - Centrum Medyczne PROMED - Site #535
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 92-213
    - Centralny Szpital Kliniczny Uniwersytetu Medycznego w odzi - Site #530
Portugal
- - Braga, Portugal, 4710-243
    - Centro Clinico Academico - Braga - Site #540
  - Carnaxide, Portugal, 2790-134
    - Centro Hospitalar de Lisboa Ocidental (CHLO), E.P.E. - Hospital de Santa Cruz (HSC) - Site #545
  - Lisbon, Portugal, 2674-514
    - Hospital Beatriz Angelo (HBA) - Site #541
  - Porto, Portugal, 4200-319
    - Servico de Nefrologia - Centro Hospitalar Universitario Sao Joao (CHUSJ), EPE - Site #544
  - Porto, Portugal, 4434-502
    - Centro Hospitalar de Vila Nova de Gaia / Espinho - Site #543
Singapore
- Central Singapore
  - Singapore, Central Singapore, Singapore, 119074
    - National University Hospital - Site #142
  - Singapore, Central Singapore, Singapore, 169608
    - Singapore General Hospital (SGH) - Site #141
  - Singapore, Central Singapore, Singapore, 308433
    - Tan Tock Seng Hospital - Site #140
South Korea
- Busan Gwang'yeogsi
  - Busan, Busan Gwang'yeogsi, South Korea, 49241
    - Pusan National University Hospital - Site #102
- Daegu Gwang'yeogsi
  - Daegu, Daegu Gwang'yeogsi, South Korea, 41944
    - Kyungpook National UniversityA Hospital - Site #112
- Gwangiu Gwang'yeogsi
  - Gwangju, Gwangiu Gwang'yeogsi, South Korea, 61469
    - Chonnam National University Hospital - Site #113
  - Gwangju, Gwangiu Gwang'yeogsi, South Korea
    - Chonnam National University Hospital - Site #113
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10444
    - National Health Insurance Service Ilsan Hospital - Site #114
- Gyeonggido
  - Anyang, Gyeonggido, South Korea, 431070
    - Hallym University Medical Center - Sacred Heart Hospital - Site #104
  - Hwasŏng, Gyeonggido, South Korea, 18450
    - Hallym University Medical Center - Dongtan Sacred Heart Hospital - Site #109
  - Seongnam, Gyeonggido, South Korea, 13620
    - Seoul National University Bundang Hospital - Site #110
- Seoul Teugbyeoisi
  - Seoul, Seoul Teugbyeoisi, South Korea, 18450
    - Asan Medical Center (AMC) - Site #111
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 134727
    - Kyung Hee University International Medical Service Gangdong Kyung Hee University KHU - Site #105
  - Seoul, Seoul Teugbyeolsi, South Korea, 3080
    - Seoul National University Hospital - Site #107
  - Seoul, Seoul Teugbyeolsi, South Korea, 5030
    - Konkuk University Medical Center - Site #108
  - Seoul, Seoul Teugbyeolsi, South Korea, 5355
    - Kangdong Sacred Heart Hospital - Site #106
  - Seoul, Seoul Teugbyeolsi, South Korea, 6351
    - Samsung Medical Center - Site #100
- Seoul Tukpyolshi
  - Seoul, Seoul Tukpyolshi, South Korea, 3722
    - Yonsei University Severance Hospital - Site #103
Spain
- - A Coruña, Spain, 15006
    - Hospital Universitario de A Corua - Site #569
  - Barakaldo, Spain, 48903
    - Hospital Universitario Cruces - Site #574
  - Barcelona, Spain, 8003
    - Hospital del Mar - Site #572
  - Barcelona, Spain, 8025
    - Fundacio Puigvert - Site #567
  - Barcelona, Spain, 8035
    - Hospital Universitari Vall d'Hebron - Site #566
  - Barcelona, Spain, 8907
    - Hospital Universitari de Bellvitge - Site #563
  - Bilbao, Spain, 28040
    - Hospital Clinico San Carlos - Site #564
  - Córdoba, Spain, 14004
    - Hospital Universitario Reina Sofia - Site #565
  - Ferrol, Spain, 15405
    - Hospital Arquitecto Marcide de Ferrol - Site #575
  - Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro - Site #570
  - Santander, Spain, 39008
    - Hospital Universitario Marques de Valdecilla - Site #560
  - Seville, Spain, 41009
    - Hospital Universitario Virgen Macarena - Site #562
  - Seville, Spain, 41013
    - Hospital Universitario Virgen del Rocio - Site #561
  - Valencia, Spain, 46017
    - Hospital Universitario Dr. Peset - Site #568
Sri Lanka
- - Colombo, Sri Lanka, 1000
    - National Hospital of Sri Lanka - Site #151
  - Galle, Sri Lanka, 80000
    - Karapitiya Teaching Hospital - Site #153
  - Kandy, Sri Lanka, 20000
    - National Hospital Kandy - Site #152
  - Kurunegala, Sri Lanka, 60000
    - Kurunegala Teaching Hospital - Site #154
  - Nugegoda, Sri Lanka, 10250
    - Sri Jayewardenepura General Hospital (SJGH) - Site #150
Taiwan
- - Kaohsiung City, Taiwan, 83301
    - Kaohsiung Chang Gung Memorial Hospital - Site #161
  - Keelung, Taiwan, 20104
    - Keelung Chang Gung Memorial Hospital - Site #160
  - New Taipei City, Taiwan, 23561
    - Shuang Ho Hospital - Site #163
  - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital - Site #162
  - Taipei, Taiwan, 10002
    - National Taiwan University Hospital - Site #164
  - Taipei, Taiwan, 112202
    - Taipei Veterans General Hospital - Site #165
Thailand
- - Bangkok, Thailand, 10300
    - Navamindradhiraj University - Site #174
  - Bangkok, Thailand, 10330
    - King Chula Memorial Hospital, Chulalongkorn University - Site #170
  - Bangkok, Thailand, 10400
    - Phramongkutklao Hospital - Site #175
  - Bangkok, Thailand, 10400
    - Ramathibodi Hospital - Site #171
  - Chiang Mai, Thailand, 50200
    - Chiang Mai University - Site #172
  - Khon Kaen, Thailand, 40002
    - Khon Kaen University - Site #173
United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Cambridge University Hospitals NHS Foundation Trust - Site #580
  - Gloucester, United Kingdom, GL 1 3NN
    - Gloucestershire Royal Hospital - Site #586
  - Leicester, United Kingdom, LE5 4PW
    - University Hospitals of Leicester NHS Trust - Site #581
  - London, United Kingdom, E1 1FR
    - Barts Health NHS Trust - The Royal London Hospital - Site #584
  - London, United Kingdom, NW3 2QG
    - Royal Free Hospital London NHS Trust - Site #585
  - London, United Kingdom, SE 5 9RS
    - King's College Hospital, NHS Foundation Trust - Site #582
  - Salford, United Kingdom, M5 5AP
    - Salford Royal NHS Foundation Trust - Site #583
  - Swansea, United Kingdom, SA6 6NL
    - Clinical Research Unit, Morriston Hospital - Site #588
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham - Site #336
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Arizona - Site #363
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences - Site #353
- California
  - Granada Hills, California, United States, 91344
    - Amicis Research Center - Site #341
  - La Jolla, California, United States, 92037
    - University of CA San Diego - Site #351
  - La Mesa, California, United States, 91942
    - California Institute of Renal Research - Site #371
  - Loma Linda, California, United States, 92354
    - Loma Linda University Health Care Clinical Trial Center Clinic - Site #372
  - Los Angeles, California, United States, 90022
    - Academic Medical Research Institute - Site #333
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325
  - Palo Alto, California, United States, 94304
    - Stanford University - Site #370
  - San Dimas, California, United States, 91773
    - North America Research Institute - Site #335
  - San Francisco, California, United States, 94143
    - University of California, San Francisco - Site #377
- Colorado
  - Denver, Colorado, United States, 80230
    - Colorado Kidney Care PC - Site #330
- Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic in Florida - Site #321
  - Lauderdale Lakes, Florida, United States, 33313
    - South Florida Research Institute - Site #323
  - South Miami, Florida, United States, 33143
    - Columbus Research Group - Site #376
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Fides Clinical Research North Atlanta Kidney Specialists - Site #373
  - Lawrenceville, Georgia, United States, 30046
    - Georgia Nephrology - Site #356
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals & Clinics - Site #359
- Kansas
  - Wichita, Kansas, United States, 67214
    - Kansas Nephrology Associates - Site #322
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center - Site #334
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland - Site #355
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - MGH Harvard - Site #369
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital, Division of Renal Medicine - Site #379
  - Boston, Massachusetts, United States, 02127
    - Tufts Medical Center - Site #349
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center - Site #337
  - Boston, Massachusetts, United States, 21144
    - MGH Harvard - Site #369
  - Boston, Massachusetts, United States, 21155
    - Brigham and Women's Hospital, Division of Renal Medicine - Site #379
  - Boston, Massachusetts, United States, 21277
    - Tufts Medical Center - Site #349
  - Boston, Massachusetts, United States, 22155
    - Beth Israel Deaconess Medical Center - Site #337
  - Worcester, Massachusetts, United States, 01655
    - UMASS Memorial Medical Center - Site #331
  - Worcester, Massachusetts, United States, 16555
    - UMASS Memorial Medical Center - Site #331
- Michigan
  - Roseville, Michigan, United States, 48066
    - St. Clair Nephrology Research - Site #320
- Minnesota
  - Minneapolis, Minnesota, United States, 55414
    - University of Minnesota - Site #345
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic - Rochester - Site #332
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - University of Nebraska Medical Center - Site #347
- Nevada
  - Las Vegas, Nevada, United States, 89107
    - Davita Clinical Research - Las Vegas - Site #327
- New York
  - Great Neck, New York, United States, 11021
    - Northwell Health - North Shore University Hospital NSUH - Site #346
  - New York, New York, United States, 10016
    - New York University Grossman School of Medicine - Site #362
  - The Bronx, New York, United States, 10461
    - Jacobi Medical Center - Site #364
- Ohio
  - Cincinnati, Ohio, United States, 45267
    - The University of Cincinnati - Site #343
  - Columbus, Ohio, United States, 43210
    - The Ohio State University Wexner Medical Center - Site #350
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital - Site #367
  - Providence, Rhode Island, United States, 29033
    - Rhode Island Hospital - Site #367
- South Dakota
  - Dakota Dunes, South Dakota, United States, 57029
    - Dunes Clinical Research LLC - Site #374
- Texas
  - Austin, Texas, United States, 78751
    - Research Management, Inc - Site #354
  - Dallas, Texas, United States, 75235
    - Renal Disease Research Institute - Site #378
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine (BCM) Medical Center - Site #375
  - Houston, Texas, United States, 77054
    - Prolato Clinical Research Center (PCRC) - Site #324
  - Houston, Texas, United States, 77099
    - Pioneer Research Solutions, Inc. - Site #339
  - San Antonio, Texas, United States, 78229
    - UT Health Science Center at San Antonio - Site #368
- Utah
  - Salt Lake City, Utah, United States, 84115
    - Utah Kidney Research Institute - Site #342
- Wisconsin
  - Madison, Wisconsin, United States, 53717
    - University of Wisconsin - Site #352
  - Milwaukee, Wisconsin, United States, 53213
    - Medical College of Wisconsin - Site #361
Vietnam
- - Hanoi, Vietnam, 100000
    - Viet Duc Hospital - Site #181
  - Ho Chi Minh City, Vietnam, 72706
    - Nguyen Tri Phuong Hospital - Site #180
  - Huế, Vietnam, 49100
    - Hue Central Hospital - Site #182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Male and female patients ≥ 18 years of age .
Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the 2021 CKD-EPI equation

Exclusion Criteria:

Secondary forms of IgAN or IgA vasculitis.
Coexisting chronic kidney disease other than IgAN.
Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
Nephrotic syndrome
Serum IgG < 600 mg/dL at screening.
Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
Chronic infectious disease, or acute infectious disease at time of screening.
Type 1 diabetes, or poorly controlled Type 2 diabetes
Uncontrolled hypertension

The protocol provides additional information about these and other inclusion and exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo s.c. q 4 weeks
Active Comparator: Sibeprenlimab 400 mg s.c. q 4weeks	Drug: Sibeprenlimab 400 mg Solution for Injection Other Names: VIS649

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection Time Frame: At 9 months	At 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Annualized rate of change from baseline (slope) of eGFR Time Frame: Over 24 months	Over 24 months
Mean change of eGFR from baseline Time Frame: Over 24 months	Over 24 months
Progression to composite kidney failure (CKF) Time Frame: Time from the randomization date to first occurrence of CKF	Time from the randomization date to first occurrence of CKF
Percentage of participants with Progression to CKF Time Frame: Over 24 months	Over 24 months
Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations Time Frame: Up to Week 112	Up to Week 112
Number of Participants With Adverse Events (AEs) Time Frame: Up to Week 112	Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests Time Frame: Up to Week 112	Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Vital Signs Time Frame: Up to Week 112	Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations Time Frame: Up to Week 112	Up to Week 112
Number of Participants With Injection Site Reactions Time Frame: Up to Week 112	Up to Week 112
Evaluation of serum ADA Time Frame: Up to Week 112	Up to Week 112

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

May 13, 2026

Study Completion (Actual)

May 13, 2026

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

417-201-00007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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