Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

March 15, 2022

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2026

Conditions
Immunoglobulin A Nephropathy
Interventions
DRUG

Sibeprenlimab 400 mg

Sibeprenlimab 400 mg s.c. q 4 weeks

DRUG

Placebo

Placebo s.c. q 4 weeks

Trial Locations (297)

1000

National Hospital of Sri Lanka - Site #151, Colombo

1015

University of Santo Tomas Hospital - Site #130, Manila

1070

Hopital Erasme - Site #402, Brussels

1100

Ospedale di Belcolle Viterbo - Site #514, Viterbo

1101

National Kidney Institute - Site #132, Quezon

1112

St. Luke's Medical Center - Quezon City - Site #131, Quezon

1155

Hopital de Tenon Sorbonne Universite - Site #435, Paris

1307

Universitaetsklinikum Carl Gustav Carus - Site #450, Dresden

2031

Prince of Wales Hospital - Site #2, Randwick

2065

Royal North Shore Hospital - Site #6, Saint Leonards

2139

Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Site #13, Concord

2170

University of New South Wales (UNSW) - Liverpool Hosp - Site #11, Liverpool

2217

St. George Hospital - Site #14, Kogarah

2305

John Hunter Hospital - Site #5, New Lambton Heights

2605

Canberra Hospital - Site #3, Garran

3021

Western Health Sunshine Hospital - Site #10, St Albans

3065

The University of Melbourne - St. Vincent's Hospital Melbourne (SVHM) - Site #1, Fitzroy

3080

Seoul National University Hospital - Site #107, Seoul

3600

UZ Leuven Campus Gasthuisberg - Site #401, Genk

Ziekenhuis Oost Limburg Genk ZOL - Site #405, Genk

3722

Yonsei University Severance Hospital - Site #103, Seoul

4000

CHR de la Citadelle - Site #400, Liège

5000

Royal Adelaide Hospital - Site #12, Adelaide

5030

Konkuk University Medical Center - Site #108, Seoul

5042

Flinders Medical Centre - Site #9, Bedford Park

5355

Kangdong Sacred Heart Hospital - Site #106, Seoul

6009

Sir Charles Gairdner Hospital - Site #7, Nedlands

6150

Fiona Stanley Hospital (FSH) - Site #4, Murdoch

6351

Samsung Medical Center - Site #100, Seoul

7023

Centro de Salud Renal Junin S.R.L. - Site #803, Junín

7250

Launceston General Hospital - Site #8, Launceston

7400

Somogy Megyei Kaposi Mor Oktatokorhaz - Site #481, Kaposvár

7624

Pecsi Tudomanyegyetem, Altalanos Orvostudomanyi KarKlinikai Kozpont II - Site #482, Pécs

8003

Hospital del Mar - Site #572, Barcelona

8025

Fundacio Puigvert - Site #567, Barcelona

8035

Hospital Universitari Vall d'Hebron - Site #566, Barcelona

8907

Hospital Universitari de Bellvitge - Site #563, Barcelona

9000

AZ Sint Lucas - Site #403, Ghent

10000

Klinicka Bolnica Dubrava (KBD) (Clinical Hospital Dubrava) - Site #411, Zagreb

University Hospital Merkur - Site #414, Zagreb

10002

National Taiwan University Hospital - Site #164, Taipei

10016

New York University Grossman School of Medicine - Site #362, New York

10250

Sri Jayewardenepura General Hospital (SJGH) - Site #150, Nugegoda

10300

Navamindradhiraj University - Site #174, Bangkok

10330

King Chula Memorial Hospital, Chulalongkorn University - Site #170, Bangkok

10400

Phramongkutklao Hospital - Site #175, Bangkok

Ramathibodi Hospital - Site #171, Bangkok

10444

National Health Insurance Service Ilsan Hospital - Site #114, Goyang-si

10461

Jacobi Medical Center - Site #364, The Bronx

11021

Northwell Health - North Shore University Hospital NSUH - Site #346, Great Neck

11527

Hippokration General Hospital of Athens, Nephrology Clinic - Site #475, Athens

12808

Vseobecna fakultni nemocnice v Praze - Site #420, Prague

13385

Hopital La Conception Centre de Nephrologie et de Transplantation Renal - Site #437, Marseille

13620

Seoul National University Bundang Hospital - Site #110, Seongnam

14004

Hospital Universitario Reina Sofia - Site #565, Córdoba

14010

The First Affiliated Hospital of Baotou Medical University - Site #29, Baotou

15006

Hospital Universitario de A Corua - Site #569, A Coruña

15405

Hospital Arquitecto Marcide de Ferrol - Site #575, Ferrol

16132

Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino - Site #503, Genova

18450

Hallym University Medical Center - Dongtan Sacred Heart Hospital - Site #109, Hwasŏng

Asan Medical Center (AMC) - Site #111, Seoul

20000

National Hospital Kandy - Site #152, Kandy

20104

Keelung Chang Gung Memorial Hospital - Site #160, Keelung

20122

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Site #513, Milan

21000

University Hospital Center Split - Site #413, Split

21201

University of Maryland - Site #355, Baltimore

22100

Galilee Medical Center (Western Galilee Hospital) - Site #495, Nahariya

23561

Shuang Ho Hospital - Site #163, New Taipei City

25100

Hospital Tengku Ampuan Afzan - Site #120, Kuantan

25123

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Site #504, Brescia

27100

Fondazione Maugeri - Site #509, Pavia

28040

Hospital Clinico San Carlos - Site #564, Bilbao

28222

Hospital Universitario Puerta de Hierro - Site #570, Madrid

29121

AUSL Hospital Guglielmo da Saliceto - Site #507, Piacenza

30046

Georgia Nephrology - Site #356, Lawrenceville

30342

Fides Clinical Research North Atlanta Kidney Specialists - Site #373, Atlanta

30450

Hospital Raja Permaisuri Bainun - Site #124, Ipoh

30900

Centre Hospitalier Universitaire de Nimes CHU - Hopital Universitaire Caremeau - Site #430, Nîmes

31000

University Hospital Center Osijek - Site #410, Osijek

32224

Mayo Clinic in Florida - Site #321, Jacksonville

33076

Hopital Pellegrin - Site #431, Bordeaux

33143

Columbus Research Group - Site #376, South Miami

33313

South Florida Research Institute - Site #323, Lauderdale Lakes

35233

University of Alabama at Birmingham - Site #336, Birmingham

36100

ULSS 6 Vicenza - Ospedale San Bortolo di Vicenza - Site #505, Vicenza

38043

CHU de Grenoble Alpes - Hopital Nord Michallon - Site #433, Grenoble

39008

Hospital Universitario Marques de Valdecilla - Site #560, Santander

40002

Khon Kaen University - Site #173, Khon Kaen

40138

IRCCS Azienda Ospedaliero-Universitaria Policlinico Sant Orsola - Site #512, Bologna

40210

DaVita Clinical Research Germany GmbH - Site #456, Düsseldorf

40705

Taichung Veterans General Hospital - Site #162, Taichung

41009

Hospital Universitario Virgen Macarena - Site #562, Seville

41013

Hospital Universitario Virgen del Rocio - Site #561, Seville

41110

University of Thessaly, Nephrology Clinic - Site #474, Larissa

41944

Kyungpook National UniversityA Hospital - Site #112, Daegu

42270

Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord - Site #434, Saint-Priest-en-Jarez

43210

The Ohio State University Wexner Medical Center - Site #350, Columbus

44093

CHU Hotel Dieu, Nephrologie - Immunologie clinique - Transplantation - Site #432, Nantes

44281

Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital) - Site #490, Kfar Saba

45267

The University of Cincinnati - Site #343, Cincinnati

45500

University Hospital of Ioannina (UHI) - Nephrology Clinic - Site #471, Ioannina

46017

Hospital Universitario Dr. Peset - Site #568, Valencia

47150

Sunway Medical Centre (SMC) - Site #126, Petaling Jaya

48066

St. Clair Nephrology Research - Site #320, Roseville

48903

Hospital Universitario Cruces - Site #574, Barakaldo

49100

Rabin Medical Center - Institute of Nephrology and Hypertension - Diabetic Nephropathy Clinic - Site #493, Petah Tikva

Hue Central Hospital - Site #182, Huế

49241

Pusan National University Hospital - Site #102, Busan

50134

Azienda Ospedaliero-Universitaria Careggi Firenze - Site #500, Florence

50143

Ospedale San Giovanni di Dio - Site #506, Florence

50200

Chiang Mai University - Site #172, Chiang Mai

50586

Hospital Kuala Lumpur - Site #123, Kuala Lumpur

51092

CHU de Reims Hopital Maison Blanche - Site #442, Reims

52242

University of Iowa Hospitals & Clinics - Site #359, Iowa City

53213

Medical College of Wisconsin - Site #361, Milwaukee

53717

University of Wisconsin - Site #352, Madison

54642

Aristotle University of Thessaloniki (AUTH) - Hippokration Hospital - Site #470, Thessaloniki

55131

Universitaetsmedizin Mainz - Site #455, Mainz

55414

University of Minnesota - Site #345, Minneapolis

55905

Mayo Clinic - Rochester - Site #332, Rochester

56000

Hospital Canselor Tuanku Muhriz UKM - Site #125, Kuala Lumpur

57010

Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou) - Site #473, Thessaloniki

57029

Dunes Clinical Research LLC - Site #374, Dakota Dunes

59100

University Malaya Medical Centre - Site #121, Kuala Lumpur

60000

Kurunegala Teaching Hospital - Site #154, Kurunegala

60431

Agaplesion Markus Krankenhaus - Site #457, Frankfurt am Main

61469

Chonnam National University Hospital - Site #113, Gwangju

63003

CHU Clermont-Ferrant-Gabriel Montpied - Site #443, Clermont-Ferrand

67214

Kansas Nephrology Associates - Site #322, Wichita

68100

Hopital Emile Muller - Site #438, Mulhouse

68198

University of Nebraska Medical Center - Site #347, Omaha

70121

Ochsner Medical Center - Site #334, New Orleans

70300

Hospital Tuanku Ja'afar - Site #122, Seremban

71110

Nephrology Department, University General Hospital of Heraklion - Site #472, Heraklion

72205

University of Arkansas for Medical Sciences - Site #353, Little Rock

72706

Nguyen Tri Phuong Hospital - Site #180, Ho Chi Minh City

75235

Renal Disease Research Institute - Site #378, Dallas

77030

Baylor College of Medicine (BCM) Medical Center - Site #375, Houston

77054

Prolato Clinical Research Center (PCRC) - Site #324, Houston

77099

Pioneer Research Solutions, Inc. - Site #339, Houston

78229

UT Health Science Center at San Antonio - Site #368, San Antonio

78751

Research Management, Inc - Site #354, Austin

80000

Karapitiya Teaching Hospital - Site #153, Galle

80054

CHU Amiens-Picardie Nephrology Dialysis Transplantation - Site #440, Amiens

80131

Campania Luigi Vanvitelli - Site #510, Napoli

80230

Colorado Kidney Care PC - Site #330, Denver

83301

Kaohsiung Chang Gung Memorial Hospital - Site #161, Kaohsiung City

84092

Centre Hospitalier Henri Duffaut - Site #441, Avignon

84115

Utah Kidney Research Institute - Site #342, Salt Lake City

85054

Mayo Clinic Arizona - Site #363, Phoenix

87000

CH Limoges - Site #439, Limoges

89107

Davita Clinical Research - Las Vegas - Site #327, Las Vegas

90022

Academic Medical Research Institute - Site #333, Los Angeles

90027

Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325, Los Angeles

91031

Shaare Zedek Medical Center (SZMC) - Site #492, Jerusalem

91344

Amicis Research Center - Site #341, Granada Hills

91773

North America Research Institute - Site #335, San Dimas

91942

California Institute of Renal Research - Site #371, La Mesa

92037

University of CA San Diego - Site #351, La Jolla

92354

Loma Linda University Health Care Clinical Trial Center Clinic - Site #372, Loma Linda

94010

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor) - Site #436, Créteil

94143

University of California, San Francisco - Site #377, San Francisco

94304

Stanford University - Site #370, Palo Alto

98122

AOU Gaetano Martino di Messina U.O.C., Nefrologia e Dialisi - Site #502, Messina

100000

Viet Duc Hospital - Site #181, Hanoi

100029

Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH) - Site #36, Beijing

100033

Peking University People's Hospital - Site #32, Beijing

100034

Peking University First Hospital - Site #20, Beijing

102206

Peking University International Hospital - Site #34, Beijing

102218

Beijing Tsinghua Changgung Hospital - Site #33, Beijing

110060

Sir Ganga Ram Hospital - Site #75, New Delhi

112202

Taipei Veterans General Hospital - Site #165, Taipei

119074

National University Hospital - Site #142, Singapore

134727

Kyung Hee University International Medical Service Gangdong Kyung Hee University KHU - Site #105, Seoul

160012

Postgraduate Institute of Medical Education Research PGIMER - Site #77, Chandigarh

169608

Singapore General Hospital (SGH) - Site #141, Singapore

214023

Wuxi Peoples' Hospital affiliated to Nanjing Medical University - Site #30, Wuxi

226014

Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) - Site #76, Lucknow

250013

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) - Site #26, Jinan

264099

Yantai Yuhuangding Hospital - Site #41, Yantai

308433

Tan Tock Seng Hospital - Site #140, Singapore

310014

Zhejiang Provincial People's Hospital - Site #37, Hangzhou

330006

The First Affiliated Hospital of Nanchang University - Site #22, Nanchang

361004

Xiamen University - Zhongshan Hospital - Site #42, Xiamen

382421

Kusum Dhirajlal Hospital - Site #73, Ahmedabad

387001

Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital) - Site #70, Nadiād

410011

The Second Xiangya Hospital of Central South University - Site #44, Changsha

411057

Life Point Multispecialty Hospital - Site #84, Pune

430060

Renmin Hospital of Wuhan University - Site #24, Wuhan

431003

Mahatma Gandhi Mission Institute of Health Scienes MGMIHS - Mahatma Gandhi Mission MGM Medical Centre Research Institute - Aurangabad - Site #82, Aurangabad

431070

Hallym University Medical Center - Sacred Heart Hospital - Site #104, Anyang

500012

Osmania General Hospital (OGH) - Site #78, Hyderabad

500082

Nizams Institute of Medical Sciences NIMS - Site #81, Hyderabad

510080

Sun Yat-sen Memorial Hospital - Site #39, Guangzhou

The First Affiliated Hospital, Sun Yat - sen University - Site #40, Guangzhou

510120

The First Affiliated Hospital Of Guangzhou Medical University - Site #28, Guangzhou

518036

Peking University Shenzhen Hospital - Site #43, Shenzhen

530016

The Peoples Hospital of Guangxi zhuang Autonomous Region - Site #27, Nanning

545027

Liuzhou Workers Hospital - Site #35, Liuzhou

560054

M.S. Ramaiah Memorial Hospital - Site #72, Bengaluru

560099

Mazumdar Shaw Medical Centre - A unit of Narayana Health - Site #87, Bengaluru

576104

Manipal University - Kasturba Medical College - Site #79, Manipal

610072

Sichuan Provincial Peoples Hospital - Site #38, Chengdu

632004

Christian Medical College & Hospital (CMCH) - Vellore - Site #80, Vellore

644002

Yibin Second Peoples Hospital - Site #25, Yibin

673008

Government Medical College - Site #71, Kozhikode

695011

Government Medical College Thiruvananthapuram - Site #74, Thiruvananthapuram

710061

The First Affiliated Hospital of Xi'an Jiaotong University - Site #31, Xi'an

710077

The First Affiliated Hospital of Xi'an Medical College - Site #23, Xi'an

750004

Jiangxi Pingxiang Peoples' Hospital - Site #21, Pingxiang

999077

Queen Mary Hospital - Site #60, Hong Kong

Tung Wah Hospital - Site #61, Hong Kong

Princess Margaret Hospital - Site #62, Kowloon

Prince of Wales Hospital - Site #63, Shatin

Yan Chai Hospital - Site #64, Tsuen Wan

3436212

Technion-Israel Institute of Technology - The Lady Davis Carmel Medical Center (LDCMC) - Institute of Nephrology and Hypertension - Site #491, Haifa

7830604

The Barzilai Medical Center (The Ashkelon Hospital) - Site #494, Ashkelon

60441750

Universidade Federal do CearClinic Pro-nefron - Site #827, Fortaleza

02114

MGH Harvard - Site #369, Boston

02115

Brigham and Women's Hospital, Division of Renal Medicine - Site #379, Boston

02127

Tufts Medical Center - Site #349, Boston

02215

Beth Israel Deaconess Medical Center - Site #337, Boston

01655

UMASS Memorial Medical Center - Site #331, Worcester

02903

Rhode Island Hospital - Site #367, Providence

C1280AEB

Hospital Britanico de Buenos Aires - Site #800, Buenos Aires

C1425

Maffei Centro Medico - Site #802, Buenos Aires

X5016LIG

Clinica Privada Velez Sarsfield - Nephrology and Transplantation Service - Site #801, Córdoba

40415-065

Clinica Senhor do Bonfim Ltda CSB - Monte Serrat - Site #826, Salvador

50670-901

Recife - Site #820, Recife

90020-090

Santa Casa de Misericordia - Porto Alegre - Site #824, Porto Alegre

90035-903

Hospital de Clinicas de Porto Alegre HCPA - Site #828, Porto Alegre

89227-680

Fundacao Pro Rim - Site #821, Joinville

09090-790

Centro de Pesquisa Medica Praxis - Site #825, Santo André

15090-000

Faculdade de Medicina de Sao Jose do Rio Preto - SP FAMERP - Hospital de Base HB - Site #822, São José do Rio Preto

01246-903

Universidade de Sao Paulo (USP) - Faculdade de Medicina (FMUSP) - Site #823, São Paulo

04038-002

Universidade Federal de Sao Paulo - Escola Paulista de Medicina EPM - Hospital do Rim e Hipertensao HRIM - Site #830, São Paulo

20550-010

Universidade estadual do Rio de Janeiro - Site #831, Rio de Janeiro

T2R 0X7

University of Calgary - Health Research Innovation Centre: Sheldon Chumir Health Centre - Site #300, Calgary

L8N 4A6

St. Joseph's Healthcare Hamilton - Site #307, Hamilton

N2H 5ZB

Clinical Research Solutions Inc. - Site #301, Kitchener

L1G 2B9

Lakeridge Health Oshawa - Site #303, Oshawa

M1H 3G4

OTT Healthcare Inc. - Site #305, Scarborough Village

M4C 5T2

Office of Stephen S. Chow, MD - Site #306, Toronto

J4V 2H1

CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne - Site #302, Greenfield Park

H4A 3J1

McGill University Health Centre - Site #304, Montreal

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site #501, Roma

466-8560

Nagoya University Hospital - Site #705, Nagoya

470-1192

Fujita Health University Hospital - Site #709, Toyoake

279-002

Juntendo University - Urayasu Hospital - Site #707, Urayasu

830-0011

Kurume University Hospital - Site #725, Kurume

660-8550

Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) - Site #723, Amagasaki

650-0017

Kobe University Hospital - Site #724, Kobe

305-8576

University of Tsukuba Hospital - Site #708, Tsukuba

920-8641

Kanazawa University Hospital - Site #702, Kanazawa

213-8587

Toranomon Hospital Kajigaya - Site #714, Kawasaki

252-0375

Kitasato University Hospital - Site #729, Sagamihara

983-8512

Tohoku Medical and Pharmaceutical University Hospital - Site #718, Sendai

634-8522

Nara Medical University Hospital - Site #713, Kashihara

177-8521

Juntendo University Nerima Hospital - Site #727, Tokyo

879-5593

Oita University Hospital - Site #717, Yufu

565-0871

Osaka University Hospital - Site #719, Suita

431-3192

Hamamatsu University Hospital - Site #704, Hamamatsu

326-0843

Japanese Red Cross Ashikaga Hospital - Site #726, Ashikaga

113-8431

Juntendo University Hospital - Site #715, Bunkyō-Ku

105-8471

The Jikei University Hospital - Site #712, Minato-Ku

160-0023

Tokyo Medical University Hospital - Site #728, Shinjuku-Ku

162-8666

Tokyo Women's Medical University Hospital - Site #710, Shinjuku-Ku

173-8606

Teikyo University Hospital - Site #706, tabashi City

260-8712

NHO Chibahigashi National Hospital - Site #700, Chiba

812-8582

Kyushu University Hospital (KUH) - Site #703, Fukuoka

814-0180

Fukuoka University - Fukuoka University Hospital - Site #722, Fukuoka

889-1692

University of Miyazaki Hospital - Site #716, Miyazaki

852-8501

Nagasaki University Hospital - Site #720, Nagasaki

951-8520

Niigata University Medical & Dental Hospital - Site #711, Niigata

700-8558

Okayama University Hospital - Site #701, Okayama

558-8558

Osaka General Medical Center - Site #721, Osaka

6500 HB

Radboud Universitair Medisch Centrum - Site #520, Nijmegen

6229 HX

Maastricht University Medical Center (MUMC) - Site #523, Maastricht

2803 HH

Groene Hart Ziekenhuis, Ioc, Bleuland - Site #521, Gouda

1105 AZ

Amsterdam UMC - Site #522, Amsterdam

15-276

Uniw. Szp. Kliniczny w Bialymstoku, 2nd Department of Nephrology and Hypertension with Dialysis Unit - Site #531, Bialystok

30-688

Szpital Uniwersytecki w Krakowie - Site #533, Krakow

31-513

Centrum Medyczne PROMED - Site #535, Krakow

92-213

Centralny Szpital Kliniczny Uniwersytetu Medycznego w odzi - Site #530, Lodz

4710-243

Centro Clinico Academico - Braga - Site #540, Braga

2790-134

Centro Hospitalar de Lisboa Ocidental (CHLO), E.P.E. - Hospital de Santa Cruz (HSC) - Site #545, Carnaxide

2674-514

Hospital Beatriz Angelo (HBA) - Site #541, Lisbon

4200-319

Servico de Nefrologia - Centro Hospitalar Universitario Sao Joao (CHUSJ), EPE - Site #544, Porto

4434-502

Centro Hospitalar de Vila Nova de Gaia / Espinho - Site #543, Porto

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust - Site #580, Cambridge

GL 1 3NN

Gloucestershire Royal Hospital - Site #586, Gloucester

LE5 4PW

University Hospitals of Leicester NHS Trust - Site #581, Leicester

E1 1FR

Barts Health NHS Trust - The Royal London Hospital - Site #584, London

NW3 2QG

Royal Free Hospital London NHS Trust - Site #585, London

SE 5 9RS

King's College Hospital, NHS Foundation Trust - Site #582, London

M5 5AP

Salford Royal NHS Foundation Trust - Site #583, Salford

SA6 6NL

Clinical Research Unit, Morriston Hospital - Site #588, Swansea

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY