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Last updated on May 2019

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

Brief description of study

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Detailed Study Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of oral Nefecon compared to matching placebo in patients with primary IgAN on a background of optimized RAS inhibitor therapy. The study will consist of 2 parts, Part A and Part B. Part A will include a 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B will consist of an observational Long-term Follow up Period in which the patients will be followed until 100 clinical events, measured as reduction in eGFR compared to baseline. Part A and B will be blinded. Safety will be monitored by an independent Data Safety Monitoring Board.

Clinical Study Identifier: NCT03643965

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Calliditas investigational site

Stanford, CA United States

University of Alabama at Birmingham, 1720 2nd Ave South

Birmingham, AL United States

Stanford University Medical Center, 777 Welch Rd

Palo Alto, CA United States

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

Torrance, CA United States

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

Aurora, CO United States

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

Westminster, CO United States

Yale University School of Medicine, 330 Cedar Street

New Haven, CT United States

Washington Nephrology Associates-Washington DC, 730 24th Street NW

Washington, WA United States

Omega Research Maitland, 7912 Forest City Rd.

Orlando, FL United States

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

Chicago, IL United States

Northshore University Health System, 2650 Ridge Av.

Evanston, IL United States

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

Lexington, KY United States

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

Springfield, MA United States

University of Minnesota, 717 Delaware St. SE

Minneapolis, MN United States

Clinical Research Consultants, LLC, 3930 Washington St

Kansas City, MO United States

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

New York, NY United States

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

New York, NY United States

Mountain Kidney & Hypertension Assoc, 10 McDowell St

Asheville, NC United States

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

Chapel Hill, NC United States

Southeastern Nephrology-Whiteville, 800 Jefferson St

Whiteville, NC United States

Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive

Wilmington, NC United States

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

Cleveland, OH United States

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

Columbus, OH United States

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

Portland, OR United States

Thomas Jefferson University, 211 S. 9th Street

Philadelphia, PA United States

Allegheny General Hospital, 4800 Friendship Av.

Pittsburgh, PA United States

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

Nashville, TN United States

Renal Disease Research Institute, 1250 Eighth Av. #135

Fort Worth, TX United States

Hospital Britanico de Buenos Aires, Pedriel 74

Capital federal, Argentina

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

Córdoba, Argentina

Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso

Córdoba, Argentina

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

Pilar, Argentina

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

Santa Fe, Argentina

Monash Medical Centre

Clayton, Australia

Royal Adelaide Hospital, Port Rd.

Adelaide, Australia

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

Box Hill, Australia

Austin Health, Dept of Nephrology, 145 Studley Rd.

Heidelberg, Australia

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

Parkville, Australia

Prince of Wales Hospital, Nephrology Dept, Parkes 3 West

Randwick, Australia

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

St Albans, Australia

Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd.

Westmead, Australia

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

Woolloongabba, Australia

Brest Regional Hospital, 7 Meditsinskaya str.

Brest, Belarus

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

Gomel, Belarus

Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola

Grodno, Belarus

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

Minsk, Belarus

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

Brussels, Belgium

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

Brussel, Belgium

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

Gent, Belgium

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

Liège, Belgium

AZ Delta, Wilgenstraat 2

Roeselare, Belgium

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

Kamloops, BC Canada

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

Kelowna, BC Canada

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

Vancouver, BC Canada

Queen Elizabeth II Health Sciences Centre, 1276 South Park St

Halifax, NS Canada

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

Toronto, ON Canada

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

Toronto, ON Canada

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

Greenfield Park, QC Canada

CHUQ-L'Hotel Dieu de Quebec, 11 c te du Palais

Québec City, QC Canada

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

Sherbrooke, QC Canada

Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20

Brno, Czechia

Fakultni nemocnice Hradec Kralove, Sokolska 581

Hradec Králové, Czechia

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

Olomouc, Czechia

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

Praha 10, Czechia

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

Praha 2, Czechia

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

Helsinki, Finland

Study Cor Oy, Hoitajantie 4

Jyväskylä, Finland

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

Tampere, Finland

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

Boulogne-sur-Mer, France

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

Grenoble, France

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

Montpellier, France

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

Paris, France

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

Saint-Priest-en-Jarez, France

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

Valenciennes, France

Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30

Aachen, Germany

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

Dresden, Germany

Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18

Erlangen, Germany

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

Heidelberg, Germany

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

Lubeck, Germany

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

Munich, Germany

Universitaetsklinikum Regensburg, Abteilung f r Nephrologie, Franz-Josef-Strauss Allee 11

Regensburg, Germany

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

Athens, Greece

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

Heraklion, Greece

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

Ioánnina, Greece

University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo

Larissa, Greece

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

Níkaia, Greece

University General Hospital of Patras, Rio

Patras, Greece

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

Thessaloníki, Greece

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

Lecco, Italy

Ospedale San Carlo Borromeo, Via Pio II, 3

Milano, Italy

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

Pavia, Italy

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

Busan, Korea, Republic of

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

Daegu, Korea, Republic of

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

Daejeon, Korea, Republic of

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

Gyeonggi-do, Korea, Republic of

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

Seoul, Korea, Republic of

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

Seoul, Korea, Republic of

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

Seoul, Korea, Republic of

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

Córdoba, Argentina

Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso

Córdoba, Argentina

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

Liège, Belgium

CHUQ-L'Hotel Dieu de Quebec, 11 c te du Palais

Québec City, QC Canada

Fakultni nemocnice Hradec Kralove, Sokolska 581

Hradec Králové, Czechia

Study Cor Oy, Hoitajantie 4

Jyväskylä, Finland

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

Ioánnina, Greece

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

Níkaia, Greece

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

Thessaloníki, Greece

Recruitment Status: Open

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