Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
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.
1 other identifier
interventional
530
31 countries
308
Brief Summary
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2022
Typical duration for phase_3
308 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2026
CompletedJune 3, 2026
June 1, 2026
4.2 years
February 18, 2022
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
At 9 months
Secondary Outcomes (11)
Annualized rate of change from baseline (slope) of eGFR
Over 24 months
Mean change of eGFR from baseline
Over 24 months
Progression to composite kidney failure (CKF)
Time from the randomization date to first occurrence of CKF
Percentage of participants with Progression to CKF
Over 24 months
Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations
Up to Week 112
- +6 more secondary outcomes
Study Arms (2)
Sibeprenlimab 400 mg s.c. q 4weeks
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Solution for Injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (308)
University of Alabama at Birmingham - Site #336
Birmingham, Alabama, 35233, United States
Mayo Clinic Arizona - Site #363
Phoenix, Arizona, 85054, United States
University of Arkansas for Medical Sciences - Site #353
Little Rock, Arkansas, 72205, United States
Amicis Research Center - Site #341
Granada Hills, California, 91344, United States
University of CA San Diego - Site #351
La Jolla, California, 92037, United States
California Institute of Renal Research - Site #371
La Mesa, California, 91942, United States
Loma Linda University Health Care Clinical Trial Center Clinic - Site #372
Loma Linda, California, 92354, United States
Academic Medical Research Institute - Site #333
Los Angeles, California, 90022, United States
Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325
Los Angeles, California, 90027, United States
Stanford University - Site #370
Palo Alto, California, 94304, United States
North America Research Institute - Site #335
San Dimas, California, 91773, United States
University of California, San Francisco - Site #377
San Francisco, California, 94143, United States
Colorado Kidney Care PC - Site #330
Denver, Colorado, 80230, United States
Mayo Clinic in Florida - Site #321
Jacksonville, Florida, 32224, United States
South Florida Research Institute - Site #323
Lauderdale Lakes, Florida, 33313, United States
Columbus Research Group - Site #376
South Miami, Florida, 33143, United States
Fides Clinical Research North Atlanta Kidney Specialists - Site #373
Atlanta, Georgia, 30342, United States
Georgia Nephrology - Site #356
Lawrenceville, Georgia, 30046, United States
University of Iowa Hospitals & Clinics - Site #359
Iowa City, Iowa, 52242, United States
Kansas Nephrology Associates - Site #322
Wichita, Kansas, 67214, United States
Ochsner Medical Center - Site #334
New Orleans, Louisiana, 70121, United States
University of Maryland - Site #355
Baltimore, Maryland, 21201, United States
MGH Harvard - Site #369
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital, Division of Renal Medicine - Site #379
Boston, Massachusetts, 02115, United States
Tufts Medical Center - Site #349
Boston, Massachusetts, 02127, United States
Beth Israel Deaconess Medical Center - Site #337
Boston, Massachusetts, 02215, United States
MGH Harvard - Site #369
Boston, Massachusetts, 21144, United States
Brigham and Women's Hospital, Division of Renal Medicine - Site #379
Boston, Massachusetts, 21155, United States
Tufts Medical Center - Site #349
Boston, Massachusetts, 21277, United States
Beth Israel Deaconess Medical Center - Site #337
Boston, Massachusetts, 22155, United States
UMASS Memorial Medical Center - Site #331
Worcester, Massachusetts, 01655, United States
UMASS Memorial Medical Center - Site #331
Worcester, Massachusetts, 16555, United States
St. Clair Nephrology Research - Site #320
Roseville, Michigan, 48066, United States
University of Minnesota - Site #345
Minneapolis, Minnesota, 55414, United States
Mayo Clinic - Rochester - Site #332
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center - Site #347
Omaha, Nebraska, 68198, United States
Davita Clinical Research - Las Vegas - Site #327
Las Vegas, Nevada, 89107, United States
Northwell Health - North Shore University Hospital NSUH - Site #346
Great Neck, New York, 11021, United States
New York University Grossman School of Medicine - Site #362
New York, New York, 10016, United States
Jacobi Medical Center - Site #364
The Bronx, New York, 10461, United States
The University of Cincinnati - Site #343
Cincinnati, Ohio, 45267, United States
The Ohio State University Wexner Medical Center - Site #350
Columbus, Ohio, 43210, United States
Rhode Island Hospital - Site #367
Providence, Rhode Island, 02903, United States
Rhode Island Hospital - Site #367
Providence, Rhode Island, 29033, United States
Dunes Clinical Research LLC - Site #374
Dakota Dunes, South Dakota, 57029, United States
Research Management, Inc - Site #354
Austin, Texas, 78751, United States
Renal Disease Research Institute - Site #378
Dallas, Texas, 75235, United States
Baylor College of Medicine (BCM) Medical Center - Site #375
Houston, Texas, 77030, United States
Prolato Clinical Research Center (PCRC) - Site #324
Houston, Texas, 77054, United States
Pioneer Research Solutions, Inc. - Site #339
Houston, Texas, 77099, United States
UT Health Science Center at San Antonio - Site #368
San Antonio, Texas, 78229, United States
Utah Kidney Research Institute - Site #342
Salt Lake City, Utah, 84115, United States
University of Wisconsin - Site #352
Madison, Wisconsin, 53717, United States
Medical College of Wisconsin - Site #361
Milwaukee, Wisconsin, 53213, United States
Hospital Britanico de Buenos Aires - Site #800
Buenos Aires, C1280AEB, Argentina
Maffei Centro Medico - Site #802
Buenos Aires, C1425, Argentina
Clinica Privada Velez Sarsfield - Nephrology and Transplantation Service - Site #801
Córdoba, X5016LIG, Argentina
Centro de Salud Renal Junin S.R.L. - Site #803
Junín, 7023, Argentina
Canberra Hospital - Site #3
Garran, Australian Capital Territory, 2605, Australia
Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Site #13
Concord, New South Wales, 2139, Australia
St. George Hospital - Site #14
Kogarah, New South Wales, 2217, Australia
University of New South Wales (UNSW) - Liverpool Hosp - Site #11
Liverpool, New South Wales, 2170, Australia
John Hunter Hospital - Site #5
New Lambton Heights, New South Wales, 2305, Australia
Prince of Wales Hospital - Site #2
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital - Site #6
Saint Leonards, New South Wales, 2065, Australia
Royal Adelaide Hospital - Site #12
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre - Site #9
Bedford Park, South Australia, 5042, Australia
Launceston General Hospital - Site #8
Launceston, Tasmania, 7250, Australia
The University of Melbourne - St. Vincent's Hospital Melbourne (SVHM) - Site #1
Fitzroy, Victoria, 3065, Australia
Western Health Sunshine Hospital - Site #10
St Albans, Victoria, 3021, Australia
Fiona Stanley Hospital (FSH) - Site #4
Murdoch, Western Australia, 6150, Australia
Sir Charles Gairdner Hospital - Site #7
Nedlands, Western Australia, 6009, Australia
Hopital Erasme - Site #402
Brussels, 1070, Belgium
UZ Leuven Campus Gasthuisberg - Site #401
Genk, 3600, Belgium
Ziekenhuis Oost Limburg Genk ZOL - Site #405
Genk, 3600, Belgium
AZ Sint Lucas - Site #403
Ghent, 9000, Belgium
CHR de la Citadelle - Site #400
Liège, 4000, Belgium
Universidade Federal do CearClinic Pro-nefron - Site #827
Fortaleza, Ceará, 60441750, Brazil
Clinica Senhor do Bonfim Ltda CSB - Monte Serrat - Site #826
Salvador, Estado de Bahia, 40415-065, Brazil
Recife - Site #820
Recife, Pernambuco, 50670-901, Brazil
Santa Casa de Misericordia - Porto Alegre - Site #824
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital de Clinicas de Porto Alegre HCPA - Site #828
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Fundacao Pro Rim - Site #821
Joinville, Santa Catarina, 89227-680, Brazil
Centro de Pesquisa Medica Praxis - Site #825
Santo André, São Paulo, 09090-790, Brazil
Faculdade de Medicina de Sao Jose do Rio Preto - SP FAMERP - Hospital de Base HB - Site #822
São José do Rio Preto, São Paulo, 15090-000, Brazil
Universidade de Sao Paulo (USP) - Faculdade de Medicina (FMUSP) - Site #823
São Paulo, São Paulo, 01246-903, Brazil
Universidade Federal de Sao Paulo - Escola Paulista de Medicina EPM - Hospital do Rim e Hipertensao HRIM - Site #830
São Paulo, São Paulo, 04038-002, Brazil
Universidade estadual do Rio de Janeiro - Site #831
Rio de Janeiro, 20550-010, Brazil
University of Calgary - Health Research Innovation Centre: Sheldon Chumir Health Centre - Site #300
Calgary, Alberta, T2R 0X7, Canada
St. Joseph's Healthcare Hamilton - Site #307
Hamilton, Ontario, L8N 4A6, Canada
Clinical Research Solutions Inc. - Site #301
Kitchener, Ontario, N2H 5ZB, Canada
Lakeridge Health Oshawa - Site #303
Oshawa, Ontario, L1G 2B9, Canada
OTT Healthcare Inc. - Site #305
Scarborough Village, Ontario, M1H 3G4, Canada
Office of Stephen S. Chow, MD - Site #306
Toronto, Ontario, M4C 5T2, Canada
CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne - Site #302
Greenfield Park, Quebec, J4V 2H1, Canada
McGill University Health Centre - Site #304
Montreal, Quebec, H4A 3J1, Canada
Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH) - Site #36
Beijing, Beijing Municipality, 100029, China
Peking University People's Hospital - Site #32
Beijing, Beijing Municipality, 100033, China
Peking University First Hospital - Site #20
Beijing, Beijing Municipality, 100034, China
Peking University International Hospital - Site #34
Beijing, Beijing Municipality, 102206, China
Beijing Tsinghua Changgung Hospital - Site #33
Beijing, Beijing Municipality, 102218, China
Xiamen University - Zhongshan Hospital - Site #42
Xiamen, Fujian, 361004, China
Sun Yat-sen Memorial Hospital - Site #39
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital, Sun Yat - sen University - Site #40
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital Of Guangzhou Medical University - Site #28
Guangzhou, Guangdong, 510120, China
Peking University Shenzhen Hospital - Site #43
Shenzhen, Guangdong, 518036, China
Liuzhou Workers Hospital - Site #35
Liuzhou, Guangxi, 545027, China
The Peoples Hospital of Guangxi zhuang Autonomous Region - Site #27
Nanning, Guangxi, 530016, China
Renmin Hospital of Wuhan University - Site #24
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital of Central South University - Site #44
Changsha, Hunan, 410011, China
The First Affiliated Hospital of Baotou Medical University - Site #29
Baotou, Inner Mongolia Proviance, 14010, China
Wuxi Peoples' Hospital affiliated to Nanjing Medical University - Site #30
Wuxi, Jiangsu, 214023, China
The First Affiliated Hospital of Nanchang University - Site #22
Nanchang, Jiangxi, 330006, China
Jiangxi Pingxiang Peoples' Hospital - Site #21
Pingxiang, Jiangxi, 750004, China
The First Affiliated Hospital of Xi'an Jiaotong University - Site #31
Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xi'an Medical College - Site #23
Xi'an, Shaanxi, 710077, China
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) - Site #26
Jinan, Shandong, 250013, China
Yantai Yuhuangding Hospital - Site #41
Yantai, Shandong, 264099, China
Sichuan Provincial Peoples Hospital - Site #38
Chengdu, Sichuan, 610072, China
Yibin Second Peoples Hospital - Site #25
Yibin, Sichuan, 644002, China
Zhejiang Provincial People's Hospital - Site #37
Hangzhou, Zhejiang, 310014, China
University Hospital Center Osijek - Site #410
Osijek, 31000, Croatia
University Hospital Center Split - Site #413
Split, 21000, Croatia
Klinicka Bolnica Dubrava (KBD) (Clinical Hospital Dubrava) - Site #411
Zagreb, 10000, Croatia
University Hospital Merkur - Site #414
Zagreb, 10000, Croatia
Vseobecna fakultni nemocnice v Praze - Site #420
Prague, 12808, Czechia
Hopital Pellegrin - Site #431
Bordeaux, Aquitaine, 33076, France
CHU de Grenoble Alpes - Hopital Nord Michallon - Site #433
Grenoble, Auvergne-Rhône-Alpes, 38043, France
CHU Clermont-Ferrant-Gabriel Montpied - Site #443
Clermont-Ferrand, Auvergne, 443, France
CHU Clermont-Ferrant-Gabriel Montpied - Site #443
Clermont-Ferrand, Auvergne, 63003, France
CHU de Reims Hopital Maison Blanche - Site #442
Reims, Champagne-Ardenne, 51092, France
Centre Hospitalier Universitaire de Nimes CHU - Hopital Universitaire Caremeau - Site #430
Nîmes, Gard, 30900, France
Hopital Emile Muller - Site #438
Mulhouse, Haut-Rhin, 68100, France
CHU Amiens-Picardie Nephrology Dialysis Transplantation - Site #440
Amiens, Hauts-de-France, 80054, France
CHU Hotel Dieu, Nephrologie - Immunologie clinique - Transplantation - Site #432
Nantes, Loire-Atlantique, 44093, France
CH Limoges - Site #439
Limoges, New Aquitaine, 87000, France
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord - Site #434
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France
Centre Hospitalier Henri Duffaut - Site #441
Avignon, Provence-Alpes-Côte d'Azur Region, 84092, France
Hopital La Conception Centre de Nephrologie et de Transplantation Renal - Site #437
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor) - Site #436
Créteil, Île-de-France Region, 94010, France
Hopital de Tenon Sorbonne Universite - Site #435
Paris, Île-de-France Region, 1155, France
Agaplesion Markus Krankenhaus - Site #457
Frankfurt am Main, Hesse, 60431, Germany
DaVita Clinical Research Germany GmbH - Site #456
Düsseldorf, North Rhine-Westphalia, 40210, Germany
Universitaetsmedizin Mainz - Site #455
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum Carl Gustav Carus - Site #450
Dresden, Saxony, 1307, Germany
Hippokration General Hospital of Athens, Nephrology Clinic - Site #475
Athens, 11527, Greece
Hippokration General Hospital of Athens, Nephrology Clinical - Site #475
Athens, 11527, Greece
Nephrology Department, University General Hospital of Heraklion - Site #472
Heraklion, 71110, Greece
University Hospital of Ioannina (UHI) - Nephrology Clinic - Site #471
Ioannina, 45500, Greece
University of Thessaly, Nephrology Clinic - Site #474
Larissa, 41110, Greece
Aristotle University of Thessaloniki (AUTH) - Hippokration Hospital - Site #470
Thessaloniki, 54642, Greece
Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou) - Site #473
Thessaloniki, 57010, Greece
Queen Mary Hospital - Site #60
Hong Kong, 999077, Hong Kong
Tung Wah Hospital - Site #61
Hong Kong, 999077, Hong Kong
Princess Margaret Hospital - Site #62
Kowloon, 999077, Hong Kong
Prince of Wales Hospital - Site #63
Shatin, 999077, Hong Kong
Yan Chai Hospital - Site #64
Tsuen Wan, 999077, Hong Kong
Pecsi Tudomanyegyetem, Altalanos Orvostudomanyi KarKlinikai Kozpont II - Site #482
Pécs, Baranya, 7624, Hungary
Somogy Megyei Kaposi Mor Oktatokorhaz - Site #481
Kaposvár, Somogy County, 7400, Hungary
Kusum Dhirajlal Hospital - Site #73
Ahmedabad, Gujarat, 382421, India
Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital) - Site #70
Nadiād, Gujarat, 387001, India
M.S. Ramaiah Memorial Hospital - Site #72
Bengaluru, Karnataka, 560054, India
Mazumdar Shaw Medical Centre - A unit of Narayana Health - Site #87
Bengaluru, Karnataka, 560099, India
Manipal University - Kasturba Medical College - Site #79
Manipal, Karnataka, 576104, India
Government Medical College - Site #71
Kozhikode, Kerala, 673008, India
Government Medical College Thiruvananthapuram - Site #74
Thiruvananthapuram, Kerala, 695011, India
Mahatma Gandhi Mission Institute of Health Scienes MGMIHS - Mahatma Gandhi Mission MGM Medical Centre Research Institute - Aurangabad - Site #82
Aurangabad, Maharashtra, 431003, India
Life Point Multispecialty Hospital - Site #84
Pune, Maharashtra, 411057, India
Sir Ganga Ram Hospital - Site #75
New Delhi, National Capital Territory of Delhi, 110060, India
Postgraduate Institute of Medical Education Research PGIMER - Site #77
Chandigarh, Punjab, 160012, India
Christian Medical College & Hospital (CMCH) - Vellore - Site #80
Vellore, Tamil Nadu, 632004, India
Osmania General Hospital (OGH) - Site #78
Hyderabad, Telangana, 500012, India
Nizams Institute of Medical Sciences NIMS - Site #81
Hyderabad, Telangana, 500082, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) - Site #76
Lucknow, Uttar Pradesh, 226014, India
The Barzilai Medical Center (The Ashkelon Hospital) - Site #494
Ashkelon, 7830604, Israel
Technion-Israel Institute of Technology - The Lady Davis Carmel Medical Center (LDCMC) - Institute of Nephrology and Hypertension - Site #491
Haifa, 3436212, Israel
Shaare Zedek Medical Center (SZMC) - Site #492
Jerusalem, 91031, Israel
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital) - Site #490
Kfar Saba, 44281, Israel
Galilee Medical Center (Western Galilee Hospital) - Site #495
Nahariya, 22100, Israel
Rabin Medical Center - Institute of Nephrology and Hypertension - Diabetic Nephropathy Clinic - Site #493
Petah Tikva, 49100, Israel
IRCCS Azienda Ospedaliero-Universitaria Policlinico Sant Orsola - Site #512
Bologna, 40138, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Site #504
Brescia, 25123, Italy
Azienda Ospedaliero-Universitaria Careggi Firenze - Site #500
Florence, 50134, Italy
Ospedale San Giovanni di Dio - Site #506
Florence, 50143, Italy
Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino - Site #503
Genova, 16132, Italy
AOU Gaetano Martino de Messina U.O.C., Nefrologia e Dialisi - Site #502
Messina, 98122, Italy
AOU Gaetano Martino di Messina U.O.C., Nefrologia e Dialisi - Site #502
Messina, 98122, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Site #513
Milan, 20122, Italy
Campania Luigi Vanvitelli - Site #510
Naples, 80131, Italy
Fondazione Maugeri - Site #509
Pavia, 27100, Italy
AUSL Hospital Guglielmo da Saliceto - Site #507
Piacenza, 29121, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site #501
Roma, 00168, Italy
ULSS 6 Vicenza - Ospedale San Bortolo di Vicenza - Site #505
Vicenza, 36100, Italy
Ospedale di Belcolle Viterbo - Site #514
Viterbo, 1100, Italy
Nagoya University Hospital - Site #705
Nagoya, Aichi-ken, 466-8560, Japan
Fujita Health University Hospital - Site #709
Toyoake, Aichi-ken, 470-1192, Japan
Juntendo University - Urayasu Hospital - Site #707
Urayasu, Chiba, 279-002, Japan
Kurume University Hospital - Site #725
Kurume, Fukuoka, 830-0011, Japan
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) - Site #723
Amagasaki, Hyōgo, 660-8550, Japan
Kobe University Hospital - Site #724
Kobe, Hyōgo, 650-0017, Japan
University of Tsukuba Hospital - Site #708
Tsukuba, Ibaraki, 305-8576, Japan
Kanazawa University Hospital - Site #702
Kanazawa, Ishikawa-ken, 920-8641, Japan
Toranomon Hospital Kajigaya - Site #714
Kawasaki, Kanagawa, 213-8587, Japan
Kitasato University Hospital - Site #729
Sagamihara, Kanagawa, 252-0375, Japan
Tohoku Medical and Pharmaceutical University Hospital - Site #718
Sendai, Miyagi, 983-8512, Japan
Nara Medical University Hospital - Site #713
Kashihara, Nara, 634-8522, Japan
Juntendo University Nerima Hospital - Site #727
Tokyo, Nerima-ku, 177-8521, Japan
Oita University Hospital - Site #717
Yufu, Oita Prefecture, 879-5593, Japan
Otia University Hospital - Site #717
Yufu, Oita Prefecture, 879-5593, Japan
Osaka University Hospital - Site #719
Suita, Osaka, 565-0871, Japan
Hamamatsu University Hospital - Site #704
Hamamatsu, Shizuoka, 431-3192, Japan
Japanese Red Cross Ashikaga Hospital - Site #726
Ashikaga, Tochigi, 326-0843, Japan
Juntendo University Hospital - Site #715
Bunkyō-Ku, Tokyo, 113-8431, Japan
The Jikei University Hospital - Site #712
Minato-Ku, Tokyo, 105-8471, Japan
Tokyo Medical University Hospital - Site #728
Shinjuku-Ku, Tokyo, 160-0023, Japan
Tokyo Women's Medical University Hospital - Site #710
Shinjuku-Ku, Tokyo, 162-8666, Japan
Teikyo University Hospital - Site #706
tabashi City, Tokyo, 173-8606, Japan
NHO Chibahigashi National Hospital - Site #700
Chiba, 260-8712, Japan
Kyushu University Hospital (KUH) - Site #703
Fukuoka, 812-8582, Japan
Fukuoka University - Fukuoka University Hospital - Site #722
Fukuoka, 814-0180, Japan
University of Miyazaki Hospital - Site #716
Miyazaki, 889-1692, Japan
Nagasaki University Hospital - Site #720
Nagasaki, 852-8501, Japan
Niigata University Medical & Dental Hospital - Site #711
Niigata, 951-8520, Japan
Okayama University Hospital - Site #701
Okayama, 700-8558, Japan
Osaka General Medical Center - Site #721
Osaka, 558-8558, Japan
Hospital Kuala Lumpur - Site #123
Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
Hospital Canselor Tuanku Muhriz UKM - Site #125
Kuala Lumpur, Kuala Lumpur, 56000, Malaysia
University Malaya Medical Centre - Site #121
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Tuanku Ja'afar - Site #122
Seremban, Negeri Sembilan, 70300, Malaysia
Hospital Tengku Ampuan Afzan - Site #120
Kuantan, Pahang, 25100, Malaysia
Hospital Raja Permaisuri Bainun - Site #124
Ipoh, Perak, 30450, Malaysia
Sunway Medical Centre (SMC) - Site #126
Petaling Jaya, Selangor, 47150, Malaysia
Radboud Universitair Medisch Centrum - Site #520
Nijmegen, Gelderland, 6500 HB, Netherlands
Maastricht University Medical Center (MUMC) - Site #523
Maastricht, Limburg, 6229 HX, Netherlands
Groene Hart Ziekenhuis, Ioc, Bleuland - Site #521
Gouda, South Holland, 2803 HH, Netherlands
Amsterdam UMC - Site #522
Amsterdam, 1105 AZ, Netherlands
University of Santo Tomas Hospital - Site #130
Manila, 1015, Philippines
National Kidney Institute - Site #132
Quezon, 1101, Philippines
St. Luke's Medical Center - Quezon City - Site #131
Quezon, 1112, Philippines
Uniw. Szp. Kliniczny w Bialymstoku, 2nd Department of Nephrology and Hypertension with Dialysis Unit - Site #531
Bialystok, Bialystok, 15-276, Poland
Szpital Uniwersytecki w Krakowie - Site #533
Krakow, Lesser Poland Voivodeship, 30-688, Poland
Centrum Medyczne PROMED - Site #535
Krakow, Malopotskie, 31-513, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w odzi - Site #530
Lodz, Łódź Voivodeship, 92-213, Poland
Centro Clinico Academico - Braga - Site #540
Braga, 4710-243, Portugal
Centro Hospitalar de Lisboa Ocidental (CHLO), E.P.E. - Hospital de Santa Cruz (HSC) - Site #545
Carnaxide, 2790-134, Portugal
Hospital Beatriz Angelo (HBA) - Site #541
Lisbon, 2674-514, Portugal
Servico de Nefrologia - Centro Hospitalar Universitario Sao Joao (CHUSJ), EPE - Site #544
Porto, 4200-319, Portugal
Centro Hospitalar de Vila Nova de Gaia / Espinho - Site #543
Porto, 4434-502, Portugal
National University Hospital - Site #142
Singapore, Central Singapore, 119074, Singapore
Singapore General Hospital (SGH) - Site #141
Singapore, Central Singapore, 169608, Singapore
Tan Tock Seng Hospital - Site #140
Singapore, Central Singapore, 308433, Singapore
Pusan National University Hospital - Site #102
Busan, Busan Gwang'yeogsi, 49241, South Korea
Kyungpook National UniversityA Hospital - Site #112
Daegu, Daegu Gwang'yeogsi, 41944, South Korea
Chonnam National University Hospital - Site #113
Gwangju, Gwangiu Gwang'yeogsi, 61469, South Korea
Chonnam National University Hospital - Site #113
Gwangju, Gwangiu Gwang'yeogsi, South Korea
National Health Insurance Service Ilsan Hospital - Site #114
Goyang-si, Gyeonggi-do, 10444, South Korea
Hallym University Medical Center - Sacred Heart Hospital - Site #104
Anyang, Gyeonggido, 431070, South Korea
Hallym University Medical Center - Dongtan Sacred Heart Hospital - Site #109
Hwasŏng, Gyeonggido, 18450, South Korea
Seoul National University Bundang Hospital - Site #110
Seongnam, Gyeonggido, 13620, South Korea
Asan Medical Center (AMC) - Site #111
Seoul, Seoul Teugbyeoisi, 18450, South Korea
Kyung Hee University International Medical Service Gangdong Kyung Hee University KHU - Site #105
Seoul, Seoul Teugbyeolsi, 134727, South Korea
Seoul National University Hospital - Site #107
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Konkuk University Medical Center - Site #108
Seoul, Seoul Teugbyeolsi, 5030, South Korea
Kangdong Sacred Heart Hospital - Site #106
Seoul, Seoul Teugbyeolsi, 5355, South Korea
Samsung Medical Center - Site #100
Seoul, Seoul Teugbyeolsi, 6351, South Korea
Yonsei University Severance Hospital - Site #103
Seoul, Seoul Tukpyolshi, 3722, South Korea
Hospital Universitario de A Corua - Site #569
A Coruña, 15006, Spain
Hospital Universitario Cruces - Site #574
Barakaldo, 48903, Spain
Hospital del Mar - Site #572
Barcelona, 8003, Spain
Fundacio Puigvert - Site #567
Barcelona, 8025, Spain
Hospital Universitari Vall d'Hebron - Site #566
Barcelona, 8035, Spain
Hospital Universitari de Bellvitge - Site #563
Barcelona, 8907, Spain
Hospital Clinico San Carlos - Site #564
Bilbao, 28040, Spain
Hospital Universitario Reina Sofia - Site #565
Córdoba, 14004, Spain
Hospital Arquitecto Marcide de Ferrol - Site #575
Ferrol, 15405, Spain
Hospital Universitario Puerta de Hierro - Site #570
Madrid, 28222, Spain
Hospital Universitario Marques de Valdecilla - Site #560
Santander, 39008, Spain
Hospital Universitario Virgen Macarena - Site #562
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio - Site #561
Seville, 41013, Spain
Hospital Universitario Dr. Peset - Site #568
Valencia, 46017, Spain
National Hospital of Sri Lanka - Site #151
Colombo, 1000, Sri Lanka
Karapitiya Teaching Hospital - Site #153
Galle, 80000, Sri Lanka
National Hospital Kandy - Site #152
Kandy, 20000, Sri Lanka
Kurunegala Teaching Hospital - Site #154
Kurunegala, 60000, Sri Lanka
Sri Jayewardenepura General Hospital (SJGH) - Site #150
Nugegoda, 10250, Sri Lanka
Kaohsiung Chang Gung Memorial Hospital - Site #161
Kaohsiung City, 83301, Taiwan
Keelung Chang Gung Memorial Hospital - Site #160
Keelung, 20104, Taiwan
Shuang Ho Hospital - Site #163
New Taipei City, 23561, Taiwan
Taichung Veterans General Hospital - Site #162
Taichung, 40705, Taiwan
National Taiwan University Hospital - Site #164
Taipei, 10002, Taiwan
Taipei Veterans General Hospital - Site #165
Taipei, 112202, Taiwan
Navamindradhiraj University - Site #174
Bangkok, 10300, Thailand
King Chula Memorial Hospital, Chulalongkorn University - Site #170
Bangkok, 10330, Thailand
Phramongkutklao Hospital - Site #175
Bangkok, 10400, Thailand
Ramathibodi Hospital - Site #171
Bangkok, 10400, Thailand
Chiang Mai University - Site #172
Chiang Mai, 50200, Thailand
Khon Kaen University - Site #173
Khon Kaen, 40002, Thailand
Cambridge University Hospitals NHS Foundation Trust - Site #580
Cambridge, CB2 0QQ, United Kingdom
Gloucestershire Royal Hospital - Site #586
Gloucester, GL 1 3NN, United Kingdom
University Hospitals of Leicester NHS Trust - Site #581
Leicester, LE5 4PW, United Kingdom
Barts Health NHS Trust - The Royal London Hospital - Site #584
London, E1 1FR, United Kingdom
Royal Free Hospital London NHS Trust - Site #585
London, NW3 2QG, United Kingdom
King's College Hospital, NHS Foundation Trust - Site #582
London, SE 5 9RS, United Kingdom
Salford Royal NHS Foundation Trust - Site #583
Salford, M5 5AP, United Kingdom
Clinical Research Unit, Morriston Hospital - Site #588
Swansea, SA6 6NL, United Kingdom
Viet Duc Hospital - Site #181
Hanoi, 100000, Vietnam
Nguyen Tri Phuong Hospital - Site #180
Ho Chi Minh City, 72706, Vietnam
Hue Central Hospital - Site #182
Huế, 49100, Vietnam
Related Publications (3)
Perkovic V, Barratt J, Lafayette R, Liew A, Suzuki Y, Carroll K, Cheung CK, Tesar V, Trimarchi H, Wong MG, Zhang H, Xia J, Fajardo C, Shah L, Hafkin J, Rizk DV. Evaluating Sibeprenlimab in IgA Nephropathy - Rationale and Baseline Data from the VISIONARY Trial. Kidney Int Rep. 2025 Oct 1;10(12):4207-4218. doi: 10.1016/j.ekir.2025.09.031. eCollection 2025 Dec.
PMID: 41426046DERIVEDPerkovic V, Trimarchi H, Tesar V, Lafayette R, Wong MG, Barratt J, Suzuki Y, Liew A, Zhang H, Carroll K, Jha V, Quevedo A, Han SH, Praga M, Chacko B, Sahay M, Cheung CK, Kooienga L, Walsh M, Xia J, Fajardo C, Shah L, Hafkin J, Rizk DV; VISIONARY Trial Investigators Group. Sibeprenlimab in IgA Nephropathy - Interim Analysis of a Phase 3 Trial. N Engl J Med. 2026 Feb 12;394(7):635-646. doi: 10.1056/NEJMoa2512133. Epub 2025 Nov 8.
PMID: 41211929DERIVEDAhmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
PMID: 40465397DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2022
First Posted
February 21, 2022
Study Start
March 15, 2022
Primary Completion
May 13, 2026
Study Completion
May 13, 2026
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
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.