Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
NCT ID: NCT03643965
Last Updated: 2024-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
365 participants
INTERVENTIONAL
2018-09-05
2023-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nefecon
Nefecon 16 mg once daily by mouth for 9 months.
Nefecon
Nefecon 16 mg for daily administration by mouth for 9 months.
Placebo oral capsule
Placebo oral capsule once daily by mouth for 9 months.
Placebo oral capsule
Placebo capsules for daily administration by mouth for 9 months.
Interventions
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Nefecon
Nefecon 16 mg for daily administration by mouth for 9 months.
Placebo oral capsule
Placebo capsules for daily administration by mouth for 9 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Biopsy-verified IgA nephropathy
3. Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
4. Urine protein creatinine ratio ≥1 g/24hr
5. eGFR ≥35 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
6. Willing and able to give informed consent
Exclusion Criteria
2. Patients who have undergone a kidney transplant.
3. Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
4. Patients with liver cirrhosis, as assessed by the Investigator.
5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
6. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
7. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
8. Patients with diagnosed malignancy within the past 5 years.
18 Years
ALL
No
Sponsors
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Calliditas Therapeutics AB
INDUSTRY
Responsible Party
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Principal Investigators
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Krassimir Mitchev, MD
Role: STUDY_DIRECTOR
Calliditas AB
Locations
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University of Alabama at Birmingham, 1720 2nd Ave South
Birmingham, Alabama, United States
Univ of Arizona, 1501 N Campbell Ave
Tucson, Arizona, United States
Stanford University Medical Center, 777 Welch Rd
Palo Alto, California, United States
Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street
Torrance, California, United States
University of Colorado Health Science Center, 1200 East 19th Av.
Aurora, Colorado, United States
Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St.
Westminster, Colorado, United States
Yale University School of Medicine, 330 Cedar Street
New Haven, Connecticut, United States
Washington Nephrology Associates-Washington DC, 730 24th Street NW
Washington D.C., District of Columbia, United States
University of Florida-Gainesville
Gainesville, Florida, United States
Omega Research Maitland, 7912 Forest City Rd.
Orlando, Florida, United States
Omega Research Maitland
Orlando, Florida, United States
Northwestern University the Feinberg School of Medicine, 633 North St. Clair
Chicago, Illinois, United States
Northshore University Health System, 2650 Ridge Av.
Evanston, Illinois, United States
University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor
Lexington, Kentucky, United States
University of Louisville-Nephrology
Louisville, Kentucky, United States
Kidney Care and Transplant Services of New England, PC, 354 Birnie Av.
Springfield, Massachusetts, United States
University of Minnesota, 717 Delaware St. SE
Minneapolis, Minnesota, United States
Clinical Research Consultants, LLC, 3930 Washington St
Kansas City, Missouri, United States
Queens Hospital Centre
Jamaica, New York, United States
Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place
New York, New York, United States
Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av
New York, New York, United States
Mountain Kidney & Hypertension Assoc, 10 McDowell St
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Centre
Chapel Hill, North Carolina, United States
Southeastern Nephrology-Whiteville, 800 Jefferson St
Whiteville, North Carolina, United States
Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive
Wilmington, North Carolina, United States
Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av.
Cleveland, Ohio, United States
The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av.
Columbus, Ohio, United States
Oregon Health & Science University, 3181 SW Sam Jackson Park Rd
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University, 211 S. 9th Street
Philadelphia, Pennsylvania, United States
Allegheny General Hospital, 4800 Friendship Av.
Pittsburgh, Pennsylvania, United States
Nephrology Associates, P.C., 28 White Bridge Rd
Nashville, Tennessee, United States
Renal Disease Research Institute, 1250 Eighth Av. #135
Fort Worth, Texas, United States
University of Vermont
Burlington, Vermont, United States
Hospital Britanico de Buenos Aires, Pedriel 74
Capital Federal, , Argentina
Clinica Priv Velez Sarsfield
Córdoba, , 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, Victoria, 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
Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola
Grodno, , Belarus
Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str.
Homyel, , 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
Brussels, , Belgium
University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10
Ghent, , 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, British Columbia, Canada
Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str.
Kelowna, British Columbia, Canada
Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre, 1276 South Park St
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue
Toronto, Ontario, Canada
Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849
Toronto, Ontario, Canada
CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd
Greenfield Park, Quebec, Canada
CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais
Québec, Quebec, Canada
Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord
Sherbrooke, Quebec, 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
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2
Prague, , 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
Lübeck, , Germany
University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV
Munich, , Germany
Universitaetsklinikum Regensburg, Abteilung für 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
Ioannina, , Greece
University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo
Larissa, , Greece
General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str.
Nikaia, , Greece
University General Hospital of Patras, Rio
Pátrai, , Greece
Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str
Thessaloniki, , Greece
Azienda Ospedale Policlinico di Bari
Bari, , Italy
ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11
Lecco, , Italy
Ospedale San Carlo Borromeo, Via Pio II, 3
Milan, , Italy
Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10
Pavia, , Italy
Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego
Gdansk, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251
Lodz, , Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18
Olsztyn, , Poland
Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12
Szczecin, , Poland
Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu
Busan, , South Korea
Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu
Daegu, , South Korea
Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu
Daejeon, , South Korea
Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si
Gyeonggi-do, , South Korea
Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu
Seoul, , South Korea
Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu
Seoul, , South Korea
Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu
Seoul, , South Korea
Hospital Universitario Fundacion Alcorcon, C/Budapest 1
Alcorcón, , Spain
Hospital del Mar, Passeig Maritim 25-29
Barcelona, , Spain
Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129
Barcelona, , Spain
Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170
Barcelona, , Spain
Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80
Lleida, , Spain
Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46
Madrid, , Spain
Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n
Madrid, , Spain
Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12
Gothenburg, , Sweden
Universitetssjukhuset Linköping, Njurmedicinska kliniken
Linköping, , Sweden
Karolinska University Hospital-Huddinge, Njur-KBC M87
Stockholm, , Sweden
Danderyds sjukhus, Njurmedicinska kliniken
Stockholm, , Sweden
Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5
Uppsala, , Sweden
Kaohsiung Medical Univ Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital, No 2 Yude Rd
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital, No 138 Sheng Li Rd
Tainan City, , Taiwan
Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali
Adana, , Turkey (Türkiye)
Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53
Istanbul, , Turkey (Türkiye)
Ege University Med Faculty Dept of Internal Disease, Div of Nephrology
Izmir, , Turkey (Türkiye)
Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42
Kayseri, , Turkey (Türkiye)
Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi
Kocaeli, , Turkey (Türkiye)
Belfast City Hospital, 51 Lisburn Rd
Belfast, , United Kingdom
Southmead Hospital, Southmead Rd, Westbury-on-Trym
Bristol, , United Kingdom
Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences
Glasgow, , United Kingdom
Gloucestershire Royal Hospital, Great Western Rd
Gloucester, , United Kingdom
St James´s University Hospital, Beckett St.
Leeds, , United Kingdom
Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd
Leicester, , United Kingdom
The Royal London Hospital, Whitechapel
London, , United Kingdom
University of Manchester, Manchester Royal Infirmary, Oxford Rd
Manchester, , United Kingdom
Nottingham City Hospital, Hucknall Rd
Nottingham, , United Kingdom
Northern General Hospital, Herries Rd.
Sheffield, , United Kingdom
Countries
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References
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Fellstrom BC, Barratt J, Cook H, Coppo R, Feehally J, de Fijter JW, Floege J, Hetzel G, Jardine AG, Locatelli F, Maes BD, Mercer A, Ortiz F, Praga M, Sorensen SS, Tesar V, Del Vecchio L; NEFIGAN Trial Investigators. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389(10084):2117-2127. doi: 10.1016/S0140-6736(17)30550-0. Epub 2017 Mar 28.
Zhang H, Lafayette R, Wang B, Ying L, Zhu Z, Stone A, Kristensen J, Barratt J. Efficacy and Safety of Nefecon in Patients with IgA Nephropathy from Mainland China: 2-Year NefIgArd Trial Results. Kidney360. 2024 Dec 1;5(12):1881-1892. doi: 10.34067/KID.0000000583. Epub 2024 Oct 9.
Lafayette R, Kristensen J, Stone A, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Reich HN, Rovin BH, Barratt J; NefIgArd trial investigators. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial. Lancet. 2023 Sep 9;402(10405):859-870. doi: 10.1016/S0140-6736(23)01554-4. Epub 2023 Aug 14.
Liao J, Zhou Y, Xu X, Huang K, Chen P, Wu Y, Jin B, Hu Q, Chen G, Zhao S. Current knowledge of targeted-release budesonide in immunoglobulin A nephropathy: A comprehensive review. Front Immunol. 2023 Jan 4;13:926517. doi: 10.3389/fimmu.2022.926517. eCollection 2022.
Barratt J, Lafayette R, Kristensen J, Stone A, Cattran D, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Rovin BH; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023 Feb;103(2):391-402. doi: 10.1016/j.kint.2022.09.017. Epub 2022 Oct 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Nef-301
Identifier Type: -
Identifier Source: org_study_id