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

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)

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).

Study Overview

• Status: Completed
• Conditions: Primary IgA Nephropathy
• Intervention / Treatment: Drug: Nefecon; Drug: Placebo oral capsule

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 Type: Interventional
• Enrollment (Actual): 365
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR).	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	9 months
Renal function measured as estimated glomerular filtration rate (eGFR)	Based on eGFR measure compared to baseline calculated using the CKD-EPI formula	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of treatment-emergent adverse events.	Adverse event data collection	From enrollment and up to 2 years
Renal function	Renal function measured as eGFR using the CKD-EPI formula	Up to 2 years

Collaborators and Investigators

• Sponsor: Calliditas Therapeutics AB
• Investigators: Study Director: Krassimir Mitchev, MD, Calliditas AB

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: IgA Nephropathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, IGA; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: Nef-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No