Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

365

Participants

Timeline

Start Date

September 5, 2018

Primary Completion Date

July 10, 2023

Study Completion Date

July 10, 2023

Conditions
Primary IgA Nephropathy
Interventions
DRUG

Nefecon

Nefecon 16 mg for daily administration by mouth for 9 months.

DRUG

Placebo oral capsule

Placebo capsules for daily administration by mouth for 9 months.

Trial Locations (142)

704

National Cheng Kung University Hospital, No 138 Sheng Li Rd, Tainan City

1070

University Hospital Erasmus (Brussels), Recherche Clinique Nephrologie Transplantation, Route de Lennik 808, Brussels

1200

Cliniques Universitaires Saint-Luc, Nephrology Dept, Av. Hippocrate 10, Brussels

2031

Prince of Wales Hospital, Nephrology Dept, Parkes 3 West, Randwick

2145

Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd., Westmead

3000

Clinico de Nefrologia, Urologia Y Enfermedades Cardiovasculares, Av. Gdor Freyre 3074, Santa Fe

3021

Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building, St Albans

3052

Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str., Parkville

3084

Austin Health, Dept of Nephrology, 145 Studley Rd., Heidelberg

3128

Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5, Box Hill

3168

Monash Medical Centre, Clayton

4000

Centre Hospitalier Universitaire de Liege, Nephrology Dept. Domaine Universitaire de Sart-Tilman, Liège

4102

Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd., Woolloongabba

5000

Clinica Priv Velez Sarsfield, Córdoba

Royal Adelaide Hospital, Port Rd., Adelaide

5016

Hospital Privado-Centro Medico de Cordoba, Naciones Unidas 346, Nefrologia piso 1, Córdoba

8800

AZ Delta, Wilgenstraat 2, Roeselare

9000

University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10, Ghent

10029

Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place, New York

10032

Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av, New York

10034

Fakultni nemocnice Kralovske Vinohrady, Linterni klinika, Srobarova 1150/50, Prague

11432

Queens Hospital Centre, Jamaica

11527

General Hospital of Athens-Laiko, Nephrology Clinic, 17 Agiou Thoma Street, Athens

12808

Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2, Prague

14068

Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do

14186

Karolinska University Hospital-Huddinge, Njur-KBC M87, Stockholm

15224

Allegheny General Hospital, 4800 Friendship Av., Pittsburgh

18288

Danderyds sjukhus, Njurmedicinska kliniken, Stockholm

18454

General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str., Nikaia

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, 211 S. 9th Street, Philadelphia

20037

Washington Nephrology Associates-Washington DC, 730 24th Street NW, Washington D.C.

20153

Ospedale San Carlo Borromeo, Via Pio II, 3, Milan

23538

Universitatsklinik Schleswig-Holstein-Campus Lubek, Medizinische Klinik I, Nephrologie, Ratzeburger Allee 160, Lübeck

23900

ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11, Lecco

25198

Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80, Lleida

26504

University General Hospital of Patras, Rio, Pátrai

27100

Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10, Pavia

27599

University of North Carolina at Chapel Hill, Clinical & Translational Research Centre, Chapel Hill

28007

Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46, Madrid

28041

Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n, Madrid

28401

Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive, Wilmington

28472

Southeastern Nephrology-Whiteville, 800 Jefferson St, Whiteville

28801

Mountain Kidney & Hypertension Assoc, 10 McDowell St, Asheville

28922

Hospital Universitario Fundacion Alcorcon, C/Budapest 1, Alcorcón

30043

CHU Grenoble-Hopital Michallon, Service Nephrologie-Hemodialyse-Aphereses-Transplantation Renale, Boulevard de la Chantourne CS 10217, Grenoble

32610

University of Florida-Gainesville, Gainesville

32810

Omega Research Maitland, 7912 Forest City Rd., Orlando

Omega Research Maitland, Orlando

33520

Tampere University Hospital, P O Box 2000, Munuaiskeskus, Erakennus, 1. kerros, Tampere

34098

Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53, Istanbul

34295

Lapeyronie Hospital, Univ Hospital Montpellier, 371 Av. du Doyen Gaston Giraud, Montpellier

35015

Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu, Daejeon

35100

Ege University Med Faculty Dept of Internal Disease, Div of Nephrology, Izmir

37205

Nephrology Associates, P.C., 28 White Bridge Rd, Nashville

38039

Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42, Kayseri

40202

University of Louisville-Nephrology, Louisville

40447

China Medical University Hospital, No 2 Yude Rd, Taichung

40536

University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor, Lexington

40620

Study Cor Oy, Hoitajantie 4, Jyväskylä

40705

Taichung Veterans General Hospital, Taichung

41000

Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi, Kocaeli

41110

University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo, Larissa

41345

Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12, Gothenburg

41944

Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu, Daegu

42270

Chu St Etienne-Hopital Nord, Service de Nephrologie Dialyse Transplantation renale, Av. Albert Raimond, Saint-Priest-en-Jarez

43210

The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av., Columbus

44195

Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av., Cleveland

45110

University General Hospital of Ioannina, Nephrology Clinic, Leof. Stavros Niarchou, Ioannina

49201

Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu, Busan

50005

Fakultni nemocnice Hradec Kralove, Sokolska 581, Hradec Králové

52074

Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30, Aachen

54642

Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str, Thessaloniki

55414

University of Minnesota, 717 Delaware St. SE, Minneapolis

58185

Universitetssjukhuset Linköping, Njurmedicinska kliniken, Linköping

59322

Centre Hospitalier de Valenciennes, Service de Nephrologie-Medecine Interne, Av. Desandrouin BP 379, Valenciennes

60201

Northshore University Health System, 2650 Ridge Av., Evanston

60611

Northwestern University the Feinberg School of Medicine, 633 North St. Clair, Chicago

62321

Centre Hospitalier Boulogne sur Mer, 4eme etage Batiment Administratif, Allee Jacques Monod, Boulogne-sur-Mer

62500

Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20, Brno

64111

Clinical Research Consultants, LLC, 3930 Washington St, Kansas City

69120

Universitaetsklinikum Heidelberg-Nephrologie, Renal Clinic, Im Neuenheimer Feld 162, Heidelberg

70124

Azienda Ospedale Policlinico di Bari, Bari

71100

University Hospital of Heraklion, Nephrology Clinic, Diastaurosi Staurakion-Vouton, Heraklion

75185

Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5, Uppsala

75877

Hopital Bichat-Claude Bernard, Service de Nephrologie, 46 rue Henri Huchard, Paris

76104

Renal Disease Research Institute, 1250 Eighth Av. #135, Fort Worth

77900

Fakultni nemocnice Olomouc, I.P. Pavlova 185/6, Olomouc

80031

Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St., Westminster

80045

University of Colorado Health Science Center, 1200 East 19th Av., Aurora

80336

University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV, Munich

80756

Kaohsiung Medical Univ Chung-Ho Memorial Hospital, Kaohsiung City

85724

Univ of Arizona, 1501 N Campbell Ave, Tucson

90502

Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street, Torrance

91054

Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18, Erlangen

93053

Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11, Regensburg

94304

Stanford University Medical Center, 777 Welch Rd, Palo Alto

97239

Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland

220036

4-th N.E. Savchenko City Clinical Hospital, 110, R. Luxemburg str., Minsk

224027

Brest Regional Hospital, 7 Meditsinskaya str., Brest

230030

Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola, Grodno

246029

Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str., Homyel

35294-3412

University of Alabama at Birmingham, 1720 2nd Ave South, Birmingham

06520

Yale University School of Medicine, 330 Cedar Street, New Haven

01107

Kidney Care and Transplant Services of New England, PC, 354 Birnie Av., Springfield

05401

University of Vermont, Burlington

C1280AEB

Hospital Britanico de Buenos Aires, Pedriel 74, Capital Federal

X5000JHQ

Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso, Córdoba

B16290DT

Hospital Universitario Austral, Unidad de Investigacion Clinica, Av. J.D. Peron 1500, piso 4, Pilar

V2C 2T1

Royal Inland Hospital, Kidney Clinic, 7 South, 311 Columbia Street, Kamloops

V1Y 1T2

Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str., Kelowna

V5T 3A5

Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building, Vancouver

B3H 2Y9

Queen Elizabeth II Health Sciences Centre, 1276 South Park St, Halifax

K7L2V7

Kingston General Hospital, Kingston

M4G 3E8

Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue, Toronto

M5G2C4

Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849, Toronto

J4V 2H1

CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd, Greenfield Park

G1R 2J6

CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais, Québec

J1H 5N4

Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord, Sherbrooke

00290

Helsinki University Central Hospital (HUCH), Nephrology Clinic, Meilahti Triangle Hospital, Helsinki

01307

Universitaetsklinikum Carl Gustav Carus Dresden, Medizinische Klinik III, Nephrologie, Fetscherstr. 74, Dresden

80-211

Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego, Gdansk

92-213

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251, Lodz

10-561

Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18, Olsztyn

71-685

Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12, Szczecin

03080

Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu, Seoul

06591

Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu, Seoul

06973

Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu, Seoul

08003

Hospital del Mar, Passeig Maritim 25-29, Barcelona

08035

Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129, Barcelona

08036

Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170, Barcelona

01330

Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali, Adana

BT9 7AB

Belfast City Hospital, 51 Lisburn Rd, Belfast

BS10 5NB

Southmead Hospital, Southmead Rd, Westbury-on-Trym, Bristol

G51 4TF

Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences, Glasgow

GL1 3NN

Gloucestershire Royal Hospital, Great Western Rd, Gloucester

LS9 7TF

St James´s University Hospital, Beckett St., Leeds

LE5 4PW

Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd, Leicester

E1 1BB

The Royal London Hospital, Whitechapel, London

M13 9WL

University of Manchester, Manchester Royal Infirmary, Oxford Rd, Manchester

NG5 1PB

Nottingham City Hospital, Hucknall Rd, Nottingham

S5 7AU

Northern General Hospital, Herries Rd., Sheffield

Sponsors
All Listed Sponsors
lead

Calliditas Therapeutics AB

INDUSTRY

NCT03643965 - Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy | Biotech Hunter | Biotech Hunter