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

Sponsor
Calliditas Therapeutics AB (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03643965
Collaborator
(none)
365
142
2
52.9
2.6
0

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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 of the study will consist of a 12-month observational Follow up Period; no study drug will be administered during Part B. Part A and B will be blinded. Safety will be monitored by an independent Data Safety Monitoring Board.

Study Design

Study Type:
Interventional
Actual Enrollment :
365 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)
Actual Study Start Date :
Sep 5, 2018
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nefecon

Nefecon 16 mg once daily by mouth for 9 months.

Drug: Nefecon
Nefecon 16 mg for daily administration by mouth for 9 months.
Other Names:
  • Budesonide modified released capsule
  • Placebo Comparator: Placebo oral capsule

    Placebo oral capsule once daily by mouth for 9 months.

    Drug: Placebo oral capsule
    Placebo capsules for daily administration by mouth for 9 months.
    Other Names:
  • Placebo
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR). [9 months]

      The primary outcome measure is UPCR (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline

    2. Renal function measured as estimated glomerular filtration rate (eGFR) [Up to 2 years]

      Based on eGFR measure compared to baseline calculated using the CKD-EPI formula

    Secondary Outcome Measures

    1. The incidence of treatment-emergent adverse events. [From enrollment and up to 2 years]

      Adverse event data collection

    2. Renal function [Up to 2 years]

      Renal function measured as eGFR using the CKD-EPI formula

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Female or male patients ≥18 years

    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:
    1. Systemic diseases that may cause mesangial IgA deposition.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham, 1720 2nd Ave South Birmingham Alabama United States 35294-3412
    2 Univ of Arizona, 1501 N Campbell Ave Tucson Arizona United States 85724
    3 Stanford University Medical Center, 777 Welch Rd Palo Alto California United States 94304
    4 Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street Torrance California United States 90502
    5 University of Colorado Health Science Center, 1200 East 19th Av. Aurora Colorado United States 80045
    6 Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St. Westminster Colorado United States 80031
    7 Yale University School of Medicine, 330 Cedar Street New Haven Connecticut United States 06520
    8 Washington Nephrology Associates-Washington DC, 730 24th Street NW Washington District of Columbia United States 20037
    9 University of Florida-Gainesville Gainesville Florida United States 32610
    10 Omega Research Maitland, 7912 Forest City Rd. Orlando Florida United States 32810
    11 Omega Research Maitland Orlando Florida United States 32810
    12 Northwestern University the Feinberg School of Medicine, 633 North St. Clair Chicago Illinois United States 60611
    13 Northshore University Health System, 2650 Ridge Av. Evanston Illinois United States 60201
    14 University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor Lexington Kentucky United States 40536
    15 University of Louisville-Nephrology Louisville Kentucky United States 40202
    16 Kidney Care and Transplant Services of New England, PC, 354 Birnie Av. Springfield Massachusetts United States 01107
    17 University of Minnesota, 717 Delaware St. SE Minneapolis Minnesota United States 55414
    18 Clinical Research Consultants, LLC, 3930 Washington St Kansas City Missouri United States 64111
    19 Queens Hospital Centre Jamaica New York United States 11432
    20 Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place New York New York United States 10029
    21 Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av New York New York United States 10032
    22 Mountain Kidney & Hypertension Assoc, 10 McDowell St Asheville North Carolina United States 28801
    23 University of North Carolina at Chapel Hill, Clinical & Translational Research Centre Chapel Hill North Carolina United States 27599
    24 Southeastern Nephrology-Whiteville, 800 Jefferson St Whiteville North Carolina United States 28472
    25 Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive Wilmington North Carolina United States 28401
    26 Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av. Cleveland Ohio United States 44195
    27 The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av. Columbus Ohio United States 43210
    28 Oregon Health & Science University, 3181 SW Sam Jackson Park Rd Portland Oregon United States 97239
    29 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    30 Thomas Jefferson University, 211 S. 9th Street Philadelphia Pennsylvania United States 19107
    31 Allegheny General Hospital, 4800 Friendship Av. Pittsburgh Pennsylvania United States 15224
    32 Nephrology Associates, P.C., 28 White Bridge Rd Nashville Tennessee United States 37205
    33 Renal Disease Research Institute, 1250 Eighth Av. #135 Fort Worth Texas United States 76104
    34 University of Vermont Burlington Vermont United States 05401
    35 Hospital Britanico de Buenos Aires, Pedriel 74 Capital federal Argentina C1280AEB
    36 Clinica Priv Velez Sarsfield Córdoba Argentina 5000
    37 Hospital Privado-Centro Medico de Cordoba, Naciones Unidas 346, Nefrologia piso 1 Córdoba Argentina 5016
    38 Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso Córdoba Argentina X5000JHQ
    39 Hospital Universitario Austral, Unidad de Investigacion Clinica, Av. J.D. Peron 1500, piso 4 Pilar Argentina B16290DT
    40 Clinico de Nefrologia, Urologia Y Enfermedades Cardiovasculares, Av. Gdor Freyre 3074 Santa Fe Argentina 3000
    41 Monash Medical Centre Clayton Victoria Australia 3168
    42 Royal Adelaide Hospital, Port Rd. Adelaide Australia 5000
    43 Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5 Box Hill Australia 3128
    44 Austin Health, Dept of Nephrology, 145 Studley Rd. Heidelberg Australia 3084
    45 Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str. Parkville Australia 3052
    46 Prince of Wales Hospital, Nephrology Dept, Parkes 3 West Randwick Australia 2031
    47 Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building St Albans Australia 3021
    48 Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd. Westmead Australia 2145
    49 Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd. Woolloongabba Australia 4102
    50 Brest Regional Hospital, 7 Meditsinskaya str. Brest Belarus 224027
    51 Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str. Gomel Belarus 246029
    52 Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola Grodno Belarus 230030
    53 4-th N.E. Savchenko City Clinical Hospital, 110, R. Luxemburg str. Minsk Belarus 220036
    54 University Hospital Erasmus (Brussels), Recherche Clinique Nephrologie Transplantation, Route de Lennik 808 Brussels Belgium 1070
    55 Cliniques Universitaires Saint-Luc, Nephrology Dept, Av. Hippocrate 10 Brussel Belgium 1200
    56 University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10 Gent Belgium 9000
    57 Centre Hospitalier Universitaire de Liege, Nephrology Dept. Domaine Universitaire de Sart-Tilman Liège Belgium 4000
    58 AZ Delta, Wilgenstraat 2 Roeselare Belgium 8800
    59 Royal Inland Hospital, Kidney Clinic, 7 South, 311 Columbia Street Kamloops British Columbia Canada V2C 2T1
    60 Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str. Kelowna British Columbia Canada V1Y 1T2
    61 Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building Vancouver British Columbia Canada V5T 3A5
    62 Queen Elizabeth II Health Sciences Centre, 1276 South Park St Halifax Nova Scotia Canada B3H 2Y9
    63 Kingston General Hospital Kingston Ontario Canada K7L2V7
    64 Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue Toronto Ontario Canada M4G 3E8
    65 Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849 Toronto Ontario Canada M5G2C4
    66 CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd Greenfield Park Quebec Canada J4V 2H1
    67 CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais Québec City Quebec Canada G1R 2J6
    68 Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord Sherbrooke Quebec Canada J1H 5N4
    69 Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20 Brno Czechia 62500
    70 Fakultni nemocnice Hradec Kralove, Sokolska 581 Hradec Králové Czechia 50005
    71 Fakultni nemocnice Olomouc, I.P. Pavlova 185/6 Olomouc Czechia 77900
    72 Fakultni nemocnice Kralovske Vinohrady, Linterni klinika, Srobarova 1150/50 Praha 10 Czechia 10034
    73 Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2 Praha 2 Czechia 12808
    74 Helsinki University Central Hospital (HUCH), Nephrology Clinic, Meilahti Triangle Hospital Helsinki Finland 00290
    75 Study Cor Oy, Hoitajantie 4 Jyväskylä Finland 40620
    76 Tampere University Hospital, P O Box 2000, Munuaiskeskus, Erakennus, 1. kerros Tampere Finland 33520
    77 Centre Hospitalier Boulogne sur Mer, 4eme etage Batiment Administratif, Allee Jacques Monod Boulogne-sur-Mer France 62321
    78 CHU Grenoble-Hopital Michallon, Service Nephrologie-Hemodialyse-Aphereses-Transplantation Renale, Boulevard de la Chantourne CS 10217 Grenoble France 30043
    79 Lapeyronie Hospital, Univ Hospital Montpellier, 371 Av. du Doyen Gaston Giraud Montpellier France 34295
    80 Hopital Bichat-Claude Bernard, Service de Nephrologie, 46 rue Henri Huchard Paris France 75877
    81 Chu St Etienne-Hopital Nord, Service de Nephrologie Dialyse Transplantation renale, Av. Albert Raimond Saint-Priest-en-Jarez France 42270
    82 Centre Hospitalier de Valenciennes, Service de Nephrologie-Medecine Interne, Av. Desandrouin BP 379 Valenciennes France 59322
    83 Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30 Aachen Germany 52074
    84 Universitaetsklinikum Carl Gustav Carus Dresden, Medizinische Klinik III, Nephrologie, Fetscherstr. 74 Dresden Germany 01307
    85 Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18 Erlangen Germany 91054
    86 Universitaetsklinikum Heidelberg-Nephrologie, Renal Clinic, Im Neuenheimer Feld 162 Heidelberg Germany 69120
    87 Universitatsklinik Schleswig-Holstein-Campus Lubek, Medizinische Klinik I, Nephrologie, Ratzeburger Allee 160 Lubeck Germany 23538
    88 University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV Munich Germany 80336
    89 Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11 Regensburg Germany 93053
    90 General Hospital of Athens-Laiko, Nephrology Clinic, 17 Agiou Thoma Street Athens Greece 11527
    91 University Hospital of Heraklion, Nephrology Clinic, Diastaurosi Staurakion-Vouton Heraklion Greece 71100
    92 University General Hospital of Ioannina, Nephrology Clinic, Leof. Stavros Niarchou Ioánnina Greece 45110
    93 University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo Larissa Greece 41110
    94 General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str. Níkaia Greece 18454
    95 University General Hospital of Patras, Rio Patras Greece 26504
    96 Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str Thessaloníki Greece 54642
    97 Azienda Ospedale Policlinico di Bari Bari Italy 70124
    98 ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11 Lecco Italy 23900
    99 Ospedale San Carlo Borromeo, Via Pio II, 3 Milano Italy 20153
    100 Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10 Pavia Italy 27100
    101 Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu Busan Korea, Republic of 49201
    102 Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu Daegu Korea, Republic of 41944
    103 Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu Daejeon Korea, Republic of 35015
    104 Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si Gyeonggi-do Korea, Republic of 14068
    105 Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu Seoul Korea, Republic of 03080
    106 Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu Seoul Korea, Republic of 06591
    107 Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu Seoul Korea, Republic of 06973
    108 Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego Gdańsk Poland 80-211
    109 Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18 Olsztyn Poland 10-561
    110 Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12 Szczecin Poland 71-685
    111 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251 Łódź Poland 92-213
    112 Hospital Universitario Fundacion Alcorcon, C/Budapest 1 Alcorcón Spain 28922
    113 Hospital del Mar, Passeig Maritim 25-29 Barcelona Spain 08003
    114 Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129 Barcelona Spain 08035
    115 Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170 Barcelona Spain 08036
    116 Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80 Lleida Spain 25198
    117 Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46 Madrid Spain 28007
    118 Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n Madrid Spain 28041
    119 Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12 Göteborg Sweden 41345
    120 Universitetssjukhuset Linköping, Njurmedicinska kliniken Linköping Sweden 58185
    121 Karolinska University Hospital-Huddinge, Njur-KBC M87 Stockholm Sweden 14186
    122 Danderyds sjukhus, Njurmedicinska kliniken Stockholm Sweden 18288
    123 Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5 Uppsala Sweden 75185
    124 Kaohsiung Medical Univ Chung-Ho Memorial Hospital Kaohsiung Taiwan 80756
    125 China Medical University Hospital, No 2 Yude Rd Taichung Taiwan 40447
    126 Taichung Veterans General Hospital Taichung Taiwan 40705
    127 National Cheng Kung University Hospital, No 138 Sheng Li Rd Tainan Taiwan 704
    128 Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali Adana Turkey 01330
    129 Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53 Istanbul Turkey 34098
    130 Ege University Med Faculty Dept of Internal Disease, Div of Nephrology İzmir Turkey 35100
    131 Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42 Kayseri Turkey 38039
    132 Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi Kocaeli Turkey 41000
    133 Belfast City Hospital, 51 Lisburn Rd Belfast United Kingdom BT9 7AB
    134 Southmead Hospital, Southmead Rd, Westbury-on-Trym Bristol United Kingdom BS10 5NB
    135 Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences Glasgow United Kingdom G51 4TF
    136 Gloucestershire Royal Hospital, Great Western Rd Gloucester United Kingdom GL1 3NN
    137 St James´s University Hospital, Beckett St. Leeds United Kingdom LS9 7TF
    138 Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd Leicester United Kingdom LE5 4PW
    139 The Royal London Hospital, Whitechapel London United Kingdom E1 1BB
    140 University of Manchester, Manchester Royal Infirmary, Oxford Rd Manchester United Kingdom M13 9WL
    141 Nottingham City Hospital, Hucknall Rd Nottingham United Kingdom NG5 1PB
    142 Northern General Hospital, Herries Rd. Sheffield United Kingdom S5 7AU

    Sponsors and Collaborators

    • Calliditas Therapeutics AB

    Investigators

    • Study Director: Krassimir Mitchev, MD, Calliditas AB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Calliditas Therapeutics AB
    ClinicalTrials.gov Identifier:
    NCT03643965
    Other Study ID Numbers:
    • Nef-301
    First Posted:
    Aug 23, 2018
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Calliditas Therapeutics AB
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 13, 2021