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

Primary Purpose

Primary IgA Nephropathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nefecon
Placebo oral capsule
Sponsored by
Calliditas Therapeutics AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary IgA Nephropathy focused on measuring IgA Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham, 1720 2nd Ave South
  • Univ of Arizona, 1501 N Campbell Ave
  • Stanford University Medical Center, 777 Welch Rd
  • Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street
  • University of Colorado Health Science Center, 1200 East 19th Av.
  • Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St.
  • Yale University School of Medicine, 330 Cedar Street
  • Washington Nephrology Associates-Washington DC, 730 24th Street NW
  • University of Florida-Gainesville
  • Omega Research Maitland, 7912 Forest City Rd.
  • Omega Research Maitland
  • Northwestern University the Feinberg School of Medicine, 633 North St. Clair
  • Northshore University Health System, 2650 Ridge Av.
  • University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor
  • University of Louisville-Nephrology
  • Kidney Care and Transplant Services of New England, PC, 354 Birnie Av.
  • University of Minnesota, 717 Delaware St. SE
  • Clinical Research Consultants, LLC, 3930 Washington St
  • Queens Hospital Centre
  • Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place
  • Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av
  • Mountain Kidney & Hypertension Assoc, 10 McDowell St
  • University of North Carolina at Chapel Hill, Clinical & Translational Research Centre
  • Southeastern Nephrology-Whiteville, 800 Jefferson St
  • Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive
  • Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av.
  • The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av.
  • Oregon Health & Science University, 3181 SW Sam Jackson Park Rd
  • University of Pennsylvania
  • Thomas Jefferson University, 211 S. 9th Street
  • Allegheny General Hospital, 4800 Friendship Av.
  • Nephrology Associates, P.C., 28 White Bridge Rd
  • Renal Disease Research Institute, 1250 Eighth Av. #135
  • University of Vermont
  • Hospital Britanico de Buenos Aires, Pedriel 74
  • Clinica Priv Velez Sarsfield
  • Hospital Privado-Centro Medico de Cordoba, Naciones Unidas 346, Nefrologia piso 1
  • Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso
  • Hospital Universitario Austral, Unidad de Investigacion Clinica, Av. J.D. Peron 1500, piso 4
  • Clinico de Nefrologia, Urologia Y Enfermedades Cardiovasculares, Av. Gdor Freyre 3074
  • Monash Medical Centre
  • Royal Adelaide Hospital, Port Rd.
  • Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5
  • Austin Health, Dept of Nephrology, 145 Studley Rd.
  • Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str.
  • Prince of Wales Hospital, Nephrology Dept, Parkes 3 West
  • Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building
  • Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd.
  • Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd.
  • Brest Regional Hospital, 7 Meditsinskaya str.
  • Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str.
  • Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola
  • 4-th N.E. Savchenko City Clinical Hospital, 110, R. Luxemburg str.
  • University Hospital Erasmus (Brussels), Recherche Clinique Nephrologie Transplantation, Route de Lennik 808
  • Cliniques Universitaires Saint-Luc, Nephrology Dept, Av. Hippocrate 10
  • University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10
  • Centre Hospitalier Universitaire de Liege, Nephrology Dept. Domaine Universitaire de Sart-Tilman
  • AZ Delta, Wilgenstraat 2
  • Royal Inland Hospital, Kidney Clinic, 7 South, 311 Columbia Street
  • Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str.
  • Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building
  • Queen Elizabeth II Health Sciences Centre, 1276 South Park St
  • Kingston General Hospital
  • Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue
  • Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849
  • CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd
  • CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais
  • Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord
  • Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20
  • Fakultni nemocnice Hradec Kralove, Sokolska 581
  • Fakultni nemocnice Olomouc, I.P. Pavlova 185/6
  • Fakultni nemocnice Kralovske Vinohrady, Linterni klinika, Srobarova 1150/50
  • Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2
  • Helsinki University Central Hospital (HUCH), Nephrology Clinic, Meilahti Triangle Hospital
  • Study Cor Oy, Hoitajantie 4
  • Tampere University Hospital, P O Box 2000, Munuaiskeskus, Erakennus, 1. kerros
  • Centre Hospitalier Boulogne sur Mer, 4eme etage Batiment Administratif, Allee Jacques Monod
  • CHU Grenoble-Hopital Michallon, Service Nephrologie-Hemodialyse-Aphereses-Transplantation Renale, Boulevard de la Chantourne CS 10217
  • Lapeyronie Hospital, Univ Hospital Montpellier, 371 Av. du Doyen Gaston Giraud
  • Hopital Bichat-Claude Bernard, Service de Nephrologie, 46 rue Henri Huchard
  • Chu St Etienne-Hopital Nord, Service de Nephrologie Dialyse Transplantation renale, Av. Albert Raimond
  • Centre Hospitalier de Valenciennes, Service de Nephrologie-Medecine Interne, Av. Desandrouin BP 379
  • Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30
  • Universitaetsklinikum Carl Gustav Carus Dresden, Medizinische Klinik III, Nephrologie, Fetscherstr. 74
  • Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18
  • Universitaetsklinikum Heidelberg-Nephrologie, Renal Clinic, Im Neuenheimer Feld 162
  • Universitatsklinik Schleswig-Holstein-Campus Lubek, Medizinische Klinik I, Nephrologie, Ratzeburger Allee 160
  • University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV
  • Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11
  • General Hospital of Athens-Laiko, Nephrology Clinic, 17 Agiou Thoma Street
  • University Hospital of Heraklion, Nephrology Clinic, Diastaurosi Staurakion-Vouton
  • University General Hospital of Ioannina, Nephrology Clinic, Leof. Stavros Niarchou
  • University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo
  • General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str.
  • University General Hospital of Patras, Rio
  • Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str
  • Azienda Ospedale Policlinico di Bari
  • ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11
  • Ospedale San Carlo Borromeo, Via Pio II, 3
  • Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10
  • Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu
  • Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu
  • Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu
  • Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si
  • Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu
  • Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu
  • Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu
  • Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego
  • Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18
  • Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251
  • Hospital Universitario Fundacion Alcorcon, C/Budapest 1
  • Hospital del Mar, Passeig Maritim 25-29
  • Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129
  • Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170
  • Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80
  • Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46
  • Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n
  • Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12
  • Universitetssjukhuset Linköping, Njurmedicinska kliniken
  • Karolinska University Hospital-Huddinge, Njur-KBC M87
  • Danderyds sjukhus, Njurmedicinska kliniken
  • Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5
  • Kaohsiung Medical Univ Chung-Ho Memorial Hospital
  • China Medical University Hospital, No 2 Yude Rd
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital, No 138 Sheng Li Rd
  • Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali
  • Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53
  • Ege University Med Faculty Dept of Internal Disease, Div of Nephrology
  • Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42
  • Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi
  • Belfast City Hospital, 51 Lisburn Rd
  • Southmead Hospital, Southmead Rd, Westbury-on-Trym
  • Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences
  • Gloucestershire Royal Hospital, Great Western Rd
  • St James´s University Hospital, Beckett St.
  • Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd
  • The Royal London Hospital, Whitechapel
  • University of Manchester, Manchester Royal Infirmary, Oxford Rd
  • Nottingham City Hospital, Hucknall Rd
  • Northern General Hospital, Herries Rd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nefecon

Placebo oral capsule

Arm Description

Nefecon 16 mg once daily by mouth for 9 months.

Placebo oral capsule once daily by mouth for 9 months.

Outcomes

Primary Outcome Measures

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
Renal function measured as estimated glomerular filtration rate (eGFR)
Based on eGFR measure compared to baseline calculated using the CKD-EPI formula

Secondary Outcome Measures

The incidence of treatment-emergent adverse events.
Adverse event data collection
Renal function
Renal function measured as eGFR using the CKD-EPI formula

Full Information

First Posted
August 8, 2018
Last Updated
July 17, 2023
Sponsor
Calliditas Therapeutics AB
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1. Study Identification

Unique Protocol Identification Number
NCT03643965
Brief Title
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
Acronym
Nefigard
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calliditas Therapeutics AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary IgA Nephropathy
Keywords
IgA Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nefecon
Arm Type
Experimental
Arm Description
Nefecon 16 mg once daily by mouth for 9 months.
Arm Title
Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsule once daily by mouth for 9 months.
Intervention Type
Drug
Intervention Name(s)
Nefecon
Other Intervention Name(s)
Budesonide modified released capsule
Intervention Description
Nefecon 16 mg for daily administration by mouth for 9 months.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsules for daily administration by mouth for 9 months.
Primary Outcome Measure Information:
Title
Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR).
Description
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
Time Frame
9 months
Title
Renal function measured as estimated glomerular filtration rate (eGFR)
Description
Based on eGFR measure compared to baseline calculated using the CKD-EPI formula
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
The incidence of treatment-emergent adverse events.
Description
Adverse event data collection
Time Frame
From enrollment and up to 2 years
Title
Renal function
Description
Renal function measured as eGFR using the CKD-EPI formula
Time Frame
Up to 2 years

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28363480
Citation
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.
Results Reference
background
PubMed Identifier
36270561
Citation
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.
Results Reference
derived

Learn more about this trial

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

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