Immunoglobulin A NephropathyPhase 3NCT05248646
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
A Phase 3 study testing Sibeprenlimab 400 mg in people with Immunoglobulin A Nephropathy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 308 sites in 31 countries.
Trial summary
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy
- What is being tested?
- Sibeprenlimab 400 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 530 participants
- Where
- 308 sitesin 31 countries
- Study dates
- 15 Mar 2022to 19 Jan 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
308 sites in 31 countries.
308 sites in 31 countries
United States54 sites
Fides Clinical Research North Atlanta Kidney Specialists - Site #373
Atlanta, Georgia, 30342
Research Management, Inc - Site #354
Austin, Texas, 78751
University of Maryland - Site #355
Baltimore, Maryland, 21201
University of Alabama at Birmingham - Site #336
Birmingham, Alabama, 35233
MGH Harvard - Site #369
Boston, Massachusetts, 02114
Brigham and Women's Hospital, Division of Renal Medicine - Site #379
Boston, Massachusetts, 02115
Tufts Medical Center - Site #349
Boston, Massachusetts, 02127
Beth Israel Deaconess Medical Center - Site #337
Boston, Massachusetts, 02215
MGH Harvard - Site #369
Boston, Massachusetts, 21144
Brigham and Women's Hospital, Division of Renal Medicine - Site #379
Boston, Massachusetts, 21155
Tufts Medical Center - Site #349
Boston, Massachusetts, 21277
Beth Israel Deaconess Medical Center - Site #337
Boston, Massachusetts, 22155
The University of Cincinnati - Site #343
Cincinnati, Ohio, 45267
The Ohio State University Wexner Medical Center - Site #350
Columbus, Ohio, 43210
Dunes Clinical Research LLC - Site #374
Dakota Dunes, South Dakota, 57029
Renal Disease Research Institute - Site #378
Dallas, Texas, 75235
Colorado Kidney Care PC - Site #330
Denver, Colorado, 80230
Amicis Research Center - Site #341
Granada Hills, California, 91344
Northwell Health - North Shore University Hospital NSUH - Site #346
Great Neck, New York, 11021
Baylor College of Medicine (BCM) Medical Center - Site #375
Houston, Texas, 77030
Prolato Clinical Research Center (PCRC) - Site #324
Houston, Texas, 77054
Pioneer Research Solutions, Inc. - Site #339
Houston, Texas, 77099
University of Iowa Hospitals & Clinics - Site #359
Iowa City, Iowa, 52242
Mayo Clinic in Florida - Site #321
Jacksonville, Florida, 32224
University of CA San Diego - Site #351
La Jolla, California, 92037
California Institute of Renal Research - Site #371
La Mesa, California, 91942
Davita Clinical Research - Las Vegas - Site #327
Las Vegas, Nevada, 89107
South Florida Research Institute - Site #323
Lauderdale Lakes, Florida, 33313
Georgia Nephrology - Site #356
Lawrenceville, Georgia, 30046
University of Arkansas for Medical Sciences - Site #353
Little Rock, Arkansas, 72205
Loma Linda University Health Care Clinical Trial Center Clinic - Site #372
Loma Linda, California, 92354
Academic Medical Research Institute - Site #333
Los Angeles, California, 90022
Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325
Los Angeles, California, 90027
University of Wisconsin - Site #352
Madison, Wisconsin, 53717
Medical College of Wisconsin - Site #361
Milwaukee, Wisconsin, 53213
University of Minnesota - Site #345
Minneapolis, Minnesota, 55414
Ochsner Medical Center - Site #334
New Orleans, Louisiana, 70121
New York University Grossman School of Medicine - Site #362
New York, New York, 10016
University of Nebraska Medical Center - Site #347
Omaha, Nebraska, 68198
Stanford University - Site #370
Palo Alto, California, 94304
Mayo Clinic Arizona - Site #363
Phoenix, Arizona, 85054
Rhode Island Hospital - Site #367
Providence, Rhode Island, 02903
Rhode Island Hospital - Site #367
Providence, Rhode Island, 29033
Mayo Clinic - Rochester - Site #332
Rochester, Minnesota, 55905
St. Clair Nephrology Research - Site #320
Roseville, Michigan, 48066
Utah Kidney Research Institute - Site #342
Salt Lake City, Utah, 84115
UT Health Science Center at San Antonio - Site #368
San Antonio, Texas, 78229
North America Research Institute - Site #335
San Dimas, California, 91773
University of California, San Francisco - Site #377
San Francisco, California, 94143
Columbus Research Group - Site #376
South Miami, Florida, 33143
Jacobi Medical Center - Site #364
The Bronx, New York, 10461
Kansas Nephrology Associates - Site #322
Wichita, Kansas, 67214
UMASS Memorial Medical Center - Site #331
Worcester, Massachusetts, 01655
UMASS Memorial Medical Center - Site #331
Worcester, Massachusetts, 16555
Japan31 sites
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) - Site #723
Amagasaki, Hyōgo, 660-8550
Japanese Red Cross Ashikaga Hospital - Site #726
Ashikaga, Tochigi, 326-0843
Juntendo University Hospital - Site #715
Bunkyō-Ku, Tokyo, 113-8431
NHO Chibahigashi National Hospital - Site #700
Chiba, 260-8712
Kyushu University Hospital (KUH) - Site #703
Fukuoka, 812-8582
Fukuoka University - Fukuoka University Hospital - Site #722
Fukuoka, 814-0180
Hamamatsu University Hospital - Site #704
Hamamatsu, Shizuoka, 431-3192
Kanazawa University Hospital - Site #702
Kanazawa, Ishikawa-ken, 920-8641
Nara Medical University Hospital - Site #713
Kashihara, Nara, 634-8522
Toranomon Hospital Kajigaya - Site #714
Kawasaki, Kanagawa, 213-8587
Kobe University Hospital - Site #724
Kobe, Hyōgo, 650-0017
Kurume University Hospital - Site #725
Kurume, Fukuoka, 830-0011
The Jikei University Hospital - Site #712
Minato-Ku, Tokyo, 105-8471
University of Miyazaki Hospital - Site #716
Miyazaki, 889-1692
Nagasaki University Hospital - Site #720
Nagasaki, 852-8501
Nagoya University Hospital - Site #705
Nagoya, Aichi-ken, 466-8560
Niigata University Medical & Dental Hospital - Site #711
Niigata, 951-8520
Okayama University Hospital - Site #701
Okayama, 700-8558
Osaka General Medical Center - Site #721
Osaka, 558-8558
Kitasato University Hospital - Site #729
Sagamihara, Kanagawa, 252-0375
Tohoku Medical and Pharmaceutical University Hospital - Site #718
Sendai, Miyagi, 983-8512
Tokyo Medical University Hospital - Site #728
Shinjuku-Ku, Tokyo, 160-0023
Tokyo Women's Medical University Hospital - Site #710
Shinjuku-Ku, Tokyo, 162-8666
Osaka University Hospital - Site #719
Suita, Osaka, 565-0871
Teikyo University Hospital - Site #706
tabashi City, Tokyo, 173-8606
Juntendo University Nerima Hospital - Site #727
Tokyo, Nerima-ku, 177-8521
Fujita Health University Hospital - Site #709
Toyoake, Aichi-ken, 470-1192
University of Tsukuba Hospital - Site #708
Tsukuba, Ibaraki, 305-8576
Juntendo University - Urayasu Hospital - Site #707
Urayasu, Chiba, 279-002
Oita University Hospital - Site #717
Yufu, Oita Prefecture, 879-5593
Otia University Hospital - Site #717
Yufu, Oita Prefecture, 879-5593
China25 sites
The First Affiliated Hospital of Baotou Medical University - Site #29
Baotou, Inner Mongolia Proviance, 14010
Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH) - Site #36
Beijing, Beijing Municipality, 100029
Peking University People's Hospital - Site #32
Beijing, Beijing Municipality, 100033
Peking University First Hospital - Site #20
Beijing, Beijing Municipality, 100034
Peking University International Hospital - Site #34
Beijing, Beijing Municipality, 102206
Beijing Tsinghua Changgung Hospital - Site #33
Beijing, Beijing Municipality, 102218
The Second Xiangya Hospital of Central South University - Site #44
Changsha, Hunan, 410011
Sichuan Provincial Peoples Hospital - Site #38
Chengdu, Sichuan, 610072
Sun Yat-sen Memorial Hospital - Site #39
Guangzhou, Guangdong, 510080
The First Affiliated Hospital, Sun Yat - sen University - Site #40
Guangzhou, Guangdong, 510080
The First Affiliated Hospital Of Guangzhou Medical University - Site #28
Guangzhou, Guangdong, 510120
Zhejiang Provincial People's Hospital - Site #37
Hangzhou, Zhejiang, 310014
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) - Site #26
Jinan, Shandong, 250013
Liuzhou Workers Hospital - Site #35
Liuzhou, Guangxi, 545027
The First Affiliated Hospital of Nanchang University - Site #22
Nanchang, Jiangxi, 330006
The Peoples Hospital of Guangxi zhuang Autonomous Region - Site #27
Nanning, Guangxi, 530016
Jiangxi Pingxiang Peoples' Hospital - Site #21
Pingxiang, Jiangxi, 750004
Peking University Shenzhen Hospital - Site #43
Shenzhen, Guangdong, 518036
Renmin Hospital of Wuhan University - Site #24
Wuhan, Hubei, 430060
Wuxi Peoples' Hospital affiliated to Nanjing Medical University - Site #30
Wuxi, Jiangsu, 214023
The First Affiliated Hospital of Xi'an Jiaotong University - Site #31
Xi'an, Shaanxi, 710061
The First Affiliated Hospital of Xi'an Medical College - Site #23
Xi'an, Shaanxi, 710077
Xiamen University - Zhongshan Hospital - Site #42
Xiamen, Fujian, 361004
Yantai Yuhuangding Hospital - Site #41
Yantai, Shandong, 264099
Yibin Second Peoples Hospital - Site #25
Yibin, Sichuan, 644002
France15 sites
CHU Amiens-Picardie Nephrology Dialysis Transplantation - Site #440
Amiens, Hauts-de-France, 80054
Centre Hospitalier Henri Duffaut - Site #441
Avignon, Provence-Alpes-Côte d'Azur Region, 84092
Hopital Pellegrin - Site #431
Bordeaux, Aquitaine, 33076
CHU Clermont-Ferrant-Gabriel Montpied - Site #443
Clermont-Ferrand, Auvergne, 443
CHU Clermont-Ferrant-Gabriel Montpied - Site #443
Clermont-Ferrand, Auvergne, 63003
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor) - Site #436
Créteil, Île-de-France Region, 94010
CHU de Grenoble Alpes - Hopital Nord Michallon - Site #433
Grenoble, Auvergne-Rhône-Alpes, 38043
CH Limoges - Site #439
Limoges, New Aquitaine, 87000
Hopital La Conception Centre de Nephrologie et de Transplantation Renal - Site #437
Marseille, Provence-Alpes-Côte d'Azur Region, 13385
Hopital Emile Muller - Site #438
Mulhouse, Haut-Rhin, 68100
CHU Hotel Dieu, Nephrologie - Immunologie clinique - Transplantation - Site #432
Nantes, Loire-Atlantique, 44093
Centre Hospitalier Universitaire de Nimes CHU - Hopital Universitaire Caremeau - Site #430
Nîmes, Gard, 30900
Hopital de Tenon Sorbonne Universite - Site #435
Paris, Île-de-France Region, 1155
CHU de Reims Hopital Maison Blanche - Site #442
Reims, Champagne-Ardenne, 51092
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord - Site #434
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270
India15 sites
Kusum Dhirajlal Hospital - Site #73
Ahmedabad, Gujarat, 382421
Mahatma Gandhi Mission Institute of Health Scienes MGMIHS - Mahatma Gandhi Mission MGM Medical Centre Research Institute - Aurangabad - Site #82
Aurangabad, Maharashtra, 431003
M.S. Ramaiah Memorial Hospital - Site #72
Bengaluru, Karnataka, 560054
Mazumdar Shaw Medical Centre - A unit of Narayana Health - Site #87
Bengaluru, Karnataka, 560099
Postgraduate Institute of Medical Education Research PGIMER - Site #77
Chandigarh, Punjab, 160012
Osmania General Hospital (OGH) - Site #78
Hyderabad, Telangana, 500012
Nizams Institute of Medical Sciences NIMS - Site #81
Hyderabad, Telangana, 500082
Government Medical College - Site #71
Kozhikode, Kerala, 673008
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) - Site #76
Lucknow, Uttar Pradesh, 226014
Manipal University - Kasturba Medical College - Site #79
Manipal, Karnataka, 576104
Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital) - Site #70
Nadiād, Gujarat, 387001
Sir Ganga Ram Hospital - Site #75
New Delhi, National Capital Territory of Delhi, 110060
Life Point Multispecialty Hospital - Site #84
Pune, Maharashtra, 411057
Government Medical College Thiruvananthapuram - Site #74
Thiruvananthapuram, Kerala, 695011
Christian Medical College & Hospital (CMCH) - Vellore - Site #80
Vellore, Tamil Nadu, 632004
South Korea15 sites
Hallym University Medical Center - Sacred Heart Hospital - Site #104
Anyang, Gyeonggido, 431070
Pusan National University Hospital - Site #102
Busan, Busan Gwang'yeogsi, 49241
Kyungpook National UniversityA Hospital - Site #112
Daegu, Daegu Gwang'yeogsi, 41944
National Health Insurance Service Ilsan Hospital - Site #114
Goyang-si, Gyeonggi-do, 10444
Chonnam National University Hospital - Site #113
Gwangju, Gwangiu Gwang'yeogsi, 61469
Chonnam National University Hospital - Site #113
Gwangju, Gwangiu Gwang'yeogsi
Hallym University Medical Center - Dongtan Sacred Heart Hospital - Site #109
Hwasŏng, Gyeonggido, 18450
Seoul National University Bundang Hospital - Site #110
Seongnam, Gyeonggido, 13620
Asan Medical Center (AMC) - Site #111
Seoul, Seoul Teugbyeoisi, 18450
Kyung Hee University International Medical Service Gangdong Kyung Hee University KHU - Site #105
Seoul, Seoul Teugbyeolsi, 134727
Seoul National University Hospital - Site #107
Seoul, Seoul Teugbyeolsi, 3080
Konkuk University Medical Center - Site #108
Seoul, Seoul Teugbyeolsi, 5030
Kangdong Sacred Heart Hospital - Site #106
Seoul, Seoul Teugbyeolsi, 5355
Samsung Medical Center - Site #100
Seoul, Seoul Teugbyeolsi, 6351
Yonsei University Severance Hospital - Site #103
Seoul, Seoul Tukpyolshi, 3722
Australia14 sites
Royal Adelaide Hospital - Site #12
Adelaide, South Australia, 5000
Flinders Medical Centre - Site #9
Bedford Park, South Australia, 5042
Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Site #13
Concord, New South Wales, 2139
The University of Melbourne - St. Vincent's Hospital Melbourne (SVHM) - Site #1
Fitzroy, Victoria, 3065
Canberra Hospital - Site #3
Garran, Australian Capital Territory, 2605
St. George Hospital - Site #14
Kogarah, New South Wales, 2217
Launceston General Hospital - Site #8
Launceston, Tasmania, 7250
University of New South Wales (UNSW) - Liverpool Hosp - Site #11
Liverpool, New South Wales, 2170
Fiona Stanley Hospital (FSH) - Site #4
Murdoch, Western Australia, 6150
Sir Charles Gairdner Hospital - Site #7
Nedlands, Western Australia, 6009
John Hunter Hospital - Site #5
New Lambton Heights, New South Wales, 2305
Prince of Wales Hospital - Site #2
Randwick, New South Wales, 2031
Royal North Shore Hospital - Site #6
Saint Leonards, New South Wales, 2065
Western Health Sunshine Hospital - Site #10
St Albans, Victoria, 3021
Italy14 sites
IRCCS Azienda Ospedaliero-Universitaria Policlinico Sant Orsola - Site #512
Bologna, 40138
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Site #504
Brescia, 25123
Azienda Ospedaliero-Universitaria Careggi Firenze - Site #500
Florence, 50134
Ospedale San Giovanni di Dio - Site #506
Florence, 50143
Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino - Site #503
Genova, 16132
AOU Gaetano Martino de Messina U.O.C., Nefrologia e Dialisi - Site #502
Messina, 98122
AOU Gaetano Martino di Messina U.O.C., Nefrologia e Dialisi - Site #502
Messina, 98122
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Site #513
Milan, 20122
Campania Luigi Vanvitelli - Site #510
Naples, 80131
Fondazione Maugeri - Site #509
Pavia, 27100
AUSL Hospital Guglielmo da Saliceto - Site #507
Piacenza, 29121
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site #501
Roma, 00168
ULSS 6 Vicenza - Ospedale San Bortolo di Vicenza - Site #505
Vicenza, 36100
Ospedale di Belcolle Viterbo - Site #514
Viterbo, 1100
Spain14 sites
Hospital Universitario de A Corua - Site #569
A Coruña, 15006
Hospital Universitario Cruces - Site #574
Barakaldo, 48903
Hospital del Mar - Site #572
Barcelona, 8003
Fundacio Puigvert - Site #567
Barcelona, 8025
Hospital Universitari Vall d'Hebron - Site #566
Barcelona, 8035
Hospital Universitari de Bellvitge - Site #563
Barcelona, 8907
Hospital Clinico San Carlos - Site #564
Bilbao, 28040
Hospital Universitario Reina Sofia - Site #565
Córdoba, 14004
Hospital Arquitecto Marcide de Ferrol - Site #575
Ferrol, 15405
Hospital Universitario Puerta de Hierro - Site #570
Madrid, 28222
Hospital Universitario Marques de Valdecilla - Site #560
Santander, 39008
Hospital Universitario Virgen Macarena - Site #562
Seville, 41009
Hospital Universitario Virgen del Rocio - Site #561
Seville, 41013
Hospital Universitario Dr. Peset - Site #568
Valencia, 46017
Brazil11 sites
Universidade Federal do CearClinic Pro-nefron - Site #827
Fortaleza, Ceará, 60441750
Fundacao Pro Rim - Site #821
Joinville, Santa Catarina, 89227-680
Santa Casa de Misericordia - Porto Alegre - Site #824
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital de Clinicas de Porto Alegre HCPA - Site #828
Porto Alegre, Rio Grande do Sul, 90035-903
Recife - Site #820
Recife, Pernambuco, 50670-901
Universidade estadual do Rio de Janeiro - Site #831
Rio de Janeiro, 20550-010
Clinica Senhor do Bonfim Ltda CSB - Monte Serrat - Site #826
Salvador, Estado de Bahia, 40415-065
Centro de Pesquisa Medica Praxis - Site #825
Santo André, São Paulo, 09090-790
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
Universidade de Sao Paulo (USP) - Faculdade de Medicina (FMUSP) - Site #823
São Paulo, São Paulo, 01246-903
Universidade Federal de Sao Paulo - Escola Paulista de Medicina EPM - Hospital do Rim e Hipertensao HRIM - Site #830
São Paulo, São Paulo, 04038-002
Canada8 sites
University of Calgary - Health Research Innovation Centre: Sheldon Chumir Health Centre - Site #300
Calgary, Alberta, T2R 0X7
CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne - Site #302
Greenfield Park, Quebec, J4V 2H1
St. Joseph's Healthcare Hamilton - Site #307
Hamilton, Ontario, L8N 4A6
Clinical Research Solutions Inc. - Site #301
Kitchener, Ontario, N2H 5ZB
McGill University Health Centre - Site #304
Montreal, Quebec, H4A 3J1
Lakeridge Health Oshawa - Site #303
Oshawa, Ontario, L1G 2B9
OTT Healthcare Inc. - Site #305
Scarborough Village, Ontario, M1H 3G4
Office of Stephen S. Chow, MD - Site #306
Toronto, Ontario, M4C 5T2
United Kingdom8 sites
Cambridge University Hospitals NHS Foundation Trust - Site #580
Cambridge, CB2 0QQ
Gloucestershire Royal Hospital - Site #586
Gloucester, GL 1 3NN
University Hospitals of Leicester NHS Trust - Site #581
Leicester, LE5 4PW
Barts Health NHS Trust - The Royal London Hospital - Site #584
London, E1 1FR
Royal Free Hospital London NHS Trust - Site #585
London, NW3 2QG
King's College Hospital, NHS Foundation Trust - Site #582
London, SE 5 9RS
Salford Royal NHS Foundation Trust - Site #583
Salford, M5 5AP
Clinical Research Unit, Morriston Hospital - Site #588
Swansea, SA6 6NL
Greece7 sites
Hippokration General Hospital of Athens, Nephrology Clinic - Site #475
Athens, 11527
Hippokration General Hospital of Athens, Nephrology Clinical - Site #475
Athens, 11527
Nephrology Department, University General Hospital of Heraklion - Site #472
Heraklion, 71110
University Hospital of Ioannina (UHI) - Nephrology Clinic - Site #471
Ioannina, 45500
University of Thessaly, Nephrology Clinic - Site #474
Larissa, 41110
Aristotle University of Thessaloniki (AUTH) - Hippokration Hospital - Site #470
Thessaloniki, 54642
Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou) - Site #473
Thessaloniki, 57010
Malaysia7 sites
Hospital Raja Permaisuri Bainun - Site #124
Ipoh, Perak, 30450
Hospital Kuala Lumpur - Site #123
Kuala Lumpur, Kuala Lumpur, 50586
Hospital Canselor Tuanku Muhriz UKM - Site #125
Kuala Lumpur, Kuala Lumpur, 56000
University Malaya Medical Centre - Site #121
Kuala Lumpur, Kuala Lumpur, 59100
Hospital Tengku Ampuan Afzan - Site #120
Kuantan, Pahang, 25100
Sunway Medical Centre (SMC) - Site #126
Petaling Jaya, Selangor, 47150
Hospital Tuanku Ja'afar - Site #122
Seremban, Negeri Sembilan, 70300
Israel6 sites
The Barzilai Medical Center (The Ashkelon Hospital) - Site #494
Ashkelon, 7830604
Technion-Israel Institute of Technology - The Lady Davis Carmel Medical Center (LDCMC) - Institute of Nephrology and Hypertension - Site #491
Haifa, 3436212
Shaare Zedek Medical Center (SZMC) - Site #492
Jerusalem, 91031
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital) - Site #490
Kfar Saba, 44281
Galilee Medical Center (Western Galilee Hospital) - Site #495
Nahariya, 22100
Rabin Medical Center - Institute of Nephrology and Hypertension - Diabetic Nephropathy Clinic - Site #493
Petah Tikva, 49100
Taiwan6 sites
Kaohsiung Chang Gung Memorial Hospital - Site #161
Kaohsiung City, 83301
Keelung Chang Gung Memorial Hospital - Site #160
Keelung, 20104
Shuang Ho Hospital - Site #163
New Taipei City, 23561
Taichung Veterans General Hospital - Site #162
Taichung, 40705
National Taiwan University Hospital - Site #164
Taipei, 10002
Taipei Veterans General Hospital - Site #165
Taipei, 112202
Thailand6 sites
Navamindradhiraj University - Site #174
Bangkok, 10300
King Chula Memorial Hospital, Chulalongkorn University - Site #170
Bangkok, 10330
Phramongkutklao Hospital - Site #175
Bangkok, 10400
Ramathibodi Hospital - Site #171
Bangkok, 10400
Chiang Mai University - Site #172
Chiang Mai, 50200
Khon Kaen University - Site #173
Khon Kaen, 40002
Belgium5 sites
Hopital Erasme - Site #402
Brussels, 1070
UZ Leuven Campus Gasthuisberg - Site #401
Genk, 3600
Ziekenhuis Oost Limburg Genk ZOL - Site #405
Genk, 3600
AZ Sint Lucas - Site #403
Ghent, 9000
CHR de la Citadelle - Site #400
Liège, 4000
Hong Kong5 sites
Queen Mary Hospital - Site #60
Hong Kong, 999077
Tung Wah Hospital - Site #61
Hong Kong, 999077
Princess Margaret Hospital - Site #62
Kowloon, 999077
Prince of Wales Hospital - Site #63
Shatin, 999077
Yan Chai Hospital - Site #64
Tsuen Wan, 999077
Portugal5 sites
Centro Clinico Academico - Braga - Site #540
Braga, 4710-243
Centro Hospitalar de Lisboa Ocidental (CHLO), E.P.E. - Hospital de Santa Cruz (HSC) - Site #545
Carnaxide, 2790-134
Hospital Beatriz Angelo (HBA) - Site #541
Lisbon, 2674-514
Servico de Nefrologia - Centro Hospitalar Universitario Sao Joao (CHUSJ), EPE - Site #544
Porto, 4200-319
Centro Hospitalar de Vila Nova de Gaia / Espinho - Site #543
Porto, 4434-502
Sri Lanka5 sites
National Hospital of Sri Lanka - Site #151
Colombo, 1000
Karapitiya Teaching Hospital - Site #153
Galle, 80000
National Hospital Kandy - Site #152
Kandy, 20000
Kurunegala Teaching Hospital - Site #154
Kurunegala, 60000
Sri Jayewardenepura General Hospital (SJGH) - Site #150
Nugegoda, 10250
Argentina4 sites
Hospital Britanico de Buenos Aires - Site #800
Buenos Aires, C1280AEB
Maffei Centro Medico - Site #802
Buenos Aires, C1425
Clinica Privada Velez Sarsfield - Nephrology and Transplantation Service - Site #801
Córdoba, X5016LIG
Centro de Salud Renal Junin S.R.L. - Site #803
Junín, 7023
Croatia4 sites
University Hospital Center Osijek - Site #410
Osijek, 31000
University Hospital Center Split - Site #413
Split, 21000
Klinicka Bolnica Dubrava (KBD) (Clinical Hospital Dubrava) - Site #411
Zagreb, 10000
University Hospital Merkur - Site #414
Zagreb, 10000
Germany4 sites
Universitaetsklinikum Carl Gustav Carus - Site #450
Dresden, Saxony, 1307
DaVita Clinical Research Germany GmbH - Site #456
Düsseldorf, North Rhine-Westphalia, 40210
Agaplesion Markus Krankenhaus - Site #457
Frankfurt am Main, Hesse, 60431
Universitaetsmedizin Mainz - Site #455
Mainz, Rhineland-Palatinate, 55131
Netherlands4 sites
Amsterdam UMC - Site #522
Amsterdam, 1105 AZ
Groene Hart Ziekenhuis, Ioc, Bleuland - Site #521
Gouda, South Holland, 2803 HH
Maastricht University Medical Center (MUMC) - Site #523
Maastricht, Limburg, 6229 HX
Radboud Universitair Medisch Centrum - Site #520
Nijmegen, Gelderland, 6500 HB
Poland4 sites
Uniw. Szp. Kliniczny w Bialymstoku, 2nd Department of Nephrology and Hypertension with Dialysis Unit - Site #531
Bialystok, Bialystok, 15-276
Szpital Uniwersytecki w Krakowie - Site #533
Krakow, Lesser Poland Voivodeship, 30-688
Centrum Medyczne PROMED - Site #535
Krakow, Malopotskie, 31-513
Centralny Szpital Kliniczny Uniwersytetu Medycznego w odzi - Site #530
Lodz, Łódź Voivodeship, 92-213
Philippines3 sites
University of Santo Tomas Hospital - Site #130
Manila, 1015
National Kidney Institute - Site #132
Quezon, 1101
St. Luke's Medical Center - Quezon City - Site #131
Quezon, 1112
Singapore3 sites
National University Hospital - Site #142
Singapore, Central Singapore, 119074
Singapore General Hospital (SGH) - Site #141
Singapore, Central Singapore, 169608
Tan Tock Seng Hospital - Site #140
Singapore, Central Singapore, 308433
Vietnam3 sites
Viet Duc Hospital - Site #181
Hanoi, 100000
Nguyen Tri Phuong Hospital - Site #180
Ho Chi Minh City, 72706
Hue Central Hospital - Site #182
Huế, 49100
Hungary2 sites
Somogy Megyei Kaposi Mor Oktatokorhaz - Site #481
Kaposvár, Somogy County, 7400
Pecsi Tudomanyegyetem, Altalanos Orvostudomanyi KarKlinikai Kozpont II - Site #482
Pécs, Baranya, 7624
About this study
Official title: 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
Read the 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.
- Conditions
- Immunoglobulin A Nephropathy
- Being tested
- Sibeprenlimab 400 mg, Placebo
- Keywords
- IgAN, Sibeprenlimab, VIS649
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sibeprenlimab 400 mgDrug
Also called VIS649
Solution for Injection
PlaceboDrug
Placebo s.c. q 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sibeprenlimab 400 mg s.c. q 4weeks | Active comparator | Not described Receives: Drug: Sibeprenlimab 400 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
Measured: At 9 months
Secondary outcomes (11)
Annualized rate of change (slope) of eGFR
Measured: Over 24 months
Mean change of eGFR from baseline
Measured: Over 24 months
Progression to composite kidney failure (CKF)
Measured: Time from the randomization date to first occurrence of CKF
Percentage of participants with Progression to CKF
Measured: Over 24 months
Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations
Measured: Up to Week 112
Number of Participants With Adverse Events (AEs)
Measured: Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests
Measured: Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Vital Signs
Measured: Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Measured: Up to Week 112
Number of Participants With Injection Site Reactions
Measured: Up to Week 112
Evaluation of serum ADA
Measured: Up to Week 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start15 Mar 2022
- Primary completion13 May 2026
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Immunoglobulin A NephropathyStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248646
- Sponsor's protocol ID
- 417-201-00007
- Status last verified
- Jul 2026
- First submitted
- 18 Feb 2022
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Zhang H, Liew A, Wong MG, Xie D, Wang C, Lu W, Li G, Xia J, Fajardo C, Hafkin J, Lv J. Efficacy and safety of sibeprenlimab in IgA nephropathy: interim analysis of the China cohort in the phase 3 VISIONARY trial. Clin Kidney J. 2026 Jul 8;19(8):sfag222. doi: 10.1093/ckj/sfag222. eCollection 2026 Aug.
PubMed 42633049Perkovic 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.
PubMed 41426046Perkovic 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.
PubMed 41211929Ahmad 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.
PubMed 40465397