AzTrials
AzTrials

Primary IgA NephropathyPhase 3NefigardNCT03643965

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

A Phase 3 study testing Nefecon in people with Primary IgA Nephropathy, run by Calliditas Therapeutics AB at 142 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary IgA Nephropathy
What is being tested?
Nefecon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
365 participants
Where
142 sitesin 19 countries
Study dates
5 Sep 2018to 10 Jul 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

142 sites in 19 countries.

142 sites in 19 countries

United States34 sites

  • Mountain Kidney & Hypertension Assoc, 10 McDowell St

    Asheville, North Carolina, 28801

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

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham, 1720 2nd Ave South

    Birmingham, Alabama, 35294-3412

  • University of Vermont

    Burlington, Vermont, 05401

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

    Chapel Hill, North Carolina, 27599

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

    Chicago, Illinois, 60611

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

    Cleveland, Ohio, 44195

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

    Columbus, Ohio, 43210

  • Northshore University Health System, 2650 Ridge Av.

    Evanston, Illinois, 60201

  • Renal Disease Research Institute, 1250 Eighth Av. #135

    Fort Worth, Texas, 76104

  • University of Florida-Gainesville

    Gainesville, Florida, 32610

  • Queens Hospital Centre

    Jamaica, New York, 11432

  • Clinical Research Consultants, LLC, 3930 Washington St

    Kansas City, Missouri, 64111

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

    Lexington, Kentucky, 40536

  • University of Louisville-Nephrology

    Louisville, Kentucky, 40202

  • University of Minnesota, 717 Delaware St. SE

    Minneapolis, Minnesota, 55414

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

    Nashville, Tennessee, 37205

  • Yale University School of Medicine, 330 Cedar Street

    New Haven, Connecticut, 06520

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

    New York, New York, 10029

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

    New York, New York, 10032

  • Omega Research Maitland, 7912 Forest City Rd.

    Orlando, Florida, 32810

  • Omega Research Maitland

    Orlando, Florida, 32810

  • Stanford University Medical Center, 777 Welch Rd

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University, 211 S. 9th Street

    Philadelphia, Pennsylvania, 19107

  • Allegheny General Hospital, 4800 Friendship Av.

    Pittsburgh, Pennsylvania, 15224

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

    Portland, Oregon, 97239

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

    Springfield, Massachusetts, 01107

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

    Torrance, California, 90502

  • Univ of Arizona, 1501 N Campbell Ave

    Tucson, Arizona, 85724

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

    Washington D.C., District of Columbia, 20037

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

    Westminster, Colorado, 80031

  • Southeastern Nephrology-Whiteville, 800 Jefferson St

    Whiteville, North Carolina, 28472

  • Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive

    Wilmington, North Carolina, 28401

Other trials in United States

Canada10 sites

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

    Greenfield Park, Quebec, J4V 2H1

  • Queen Elizabeth II Health Sciences Centre, 1276 South Park St

    Halifax, Nova Scotia, B3H 2Y9

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

    Kamloops, British Columbia, V2C 2T1

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

    Kelowna, British Columbia, V1Y 1T2

  • Kingston General Hospital

    Kingston, Ontario, K7L2V7

  • CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais

    Québec, Quebec, G1R 2J6

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

    Sherbrooke, Quebec, J1H 5N4

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

    Toronto, Ontario, M4G 3E8

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

    Toronto, Ontario, M5G2C4

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

    Vancouver, British Columbia, V5T 3A5

Other trials in Canada

United Kingdom10 sites

  • Belfast City Hospital, 51 Lisburn Rd

    Belfast, BT9 7AB

  • Southmead Hospital, Southmead Rd, Westbury-on-Trym

    Bristol, BS10 5NB

  • Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences

    Glasgow, G51 4TF

  • Gloucestershire Royal Hospital, Great Western Rd

    Gloucester, GL1 3NN

  • St James´s University Hospital, Beckett St.

    Leeds, LS9 7TF

  • Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd

    Leicester, LE5 4PW

  • The Royal London Hospital, Whitechapel

    London, E1 1BB

  • University of Manchester, Manchester Royal Infirmary, Oxford Rd

    Manchester, M13 9WL

  • Nottingham City Hospital, Hucknall Rd

    Nottingham, NG5 1PB

  • Northern General Hospital, Herries Rd.

    Sheffield, S5 7AU

Other trials in United Kingdom

Australia9 sites

  • Royal Adelaide Hospital, Port Rd.

    Adelaide, 5000

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

    Box Hill, 3128

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Austin Health, Dept of Nephrology, 145 Studley Rd.

    Heidelberg, 3084

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

    Parkville, 3052

  • Prince of Wales Hospital, Nephrology Dept, Parkes 3 West

    Randwick, 2031

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

    St Albans, 3021

  • Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd.

    Westmead, 2145

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

    Woolloongabba, 4102

Other trials in Australia

Germany7 sites

  • Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30

    Aachen, 52074

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

    Dresden, 01307

  • Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18

    Erlangen, 91054

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

    Heidelberg, 69120

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

    Lübeck, 23538

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

    Munich, 80336

  • Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11

    Regensburg, 93053

Other trials in Germany

Greece7 sites

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

    Athens, 11527

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

    Heraklion, 71100

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

    Ioannina, 45110

  • University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo

    Larissa, 41110

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

    Nikaia, 18454

  • University General Hospital of Patras, Rio

    Pátrai, 26504

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

    Thessaloniki, 54642

Other trials in Greece

South Korea7 sites

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

    Busan, 49201

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

    Daegu, 41944

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

    Daejeon, 35015

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

    Gyeonggi-do, 14068

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

    Seoul, 03080

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

    Seoul, 06591

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

    Seoul, 06973

Other trials in South Korea

Spain7 sites

  • Hospital Universitario Fundacion Alcorcon, C/Budapest 1

    Alcorcón, 28922

  • Hospital del Mar, Passeig Maritim 25-29

    Barcelona, 08003

  • Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129

    Barcelona, 08035

  • Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170

    Barcelona, 08036

  • Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80

    Lleida, 25198

  • Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46

    Madrid, 28007

  • Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n

    Madrid, 28041

Other trials in Spain

Argentina6 sites

  • Hospital Britanico de Buenos Aires, Pedriel 74

    Capital Federal, C1280AEB

  • Clinica Priv Velez Sarsfield

    Córdoba, 5000

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

    Córdoba, 5016

  • Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso

    Córdoba, X5000JHQ

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

    Pilar, B16290DT

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

    Santa Fe, 3000

Other trials in Argentina

France6 sites

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

    Boulogne-sur-Mer, 62321

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

    Grenoble, 30043

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

    Montpellier, 34295

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

    Paris, 75877

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

    Saint-Priest-en-Jarez, 42270

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

    Valenciennes, 59322

Other trials in France

Belgium5 sites

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

    Brussels, 1070

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

    Brussels, 1200

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

    Ghent, 9000

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

    Liège, 4000

  • AZ Delta, Wilgenstraat 2

    Roeselare, 8800

Other trials in Belgium

Czechia5 sites

  • Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove, Sokolska 581

    Hradec Králové, 50005

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

    Olomouc, 77900

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

    Prague, 10034

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

    Prague, 12808

Other trials in Czechia

Sweden5 sites

  • Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12

    Gothenburg, 41345

  • Universitetssjukhuset Linköping, Njurmedicinska kliniken

    Linköping, 58185

  • Karolinska University Hospital-Huddinge, Njur-KBC M87

    Stockholm, 14186

  • Danderyds sjukhus, Njurmedicinska kliniken

    Stockholm, 18288

  • Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5

    Uppsala, 75185

Other trials in Sweden

Turkey (Türkiye)5 sites

  • Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali

    Adana, 01330

  • Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53

    Istanbul, 34098

  • Ege University Med Faculty Dept of Internal Disease, Div of Nephrology

    Izmir, 35100

  • Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42

    Kayseri, 38039

  • Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi

    Kocaeli, 41000

Other trials in Turkey (Türkiye)

Belarus4 sites

  • Brest Regional Hospital, 7 Meditsinskaya str.

    Brest, 224027

  • Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola

    Grodno, 230030

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

    Homyel, 246029

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

    Minsk, 220036

Other trials in Belarus

Italy4 sites

  • Azienda Ospedale Policlinico di Bari

    Bari, 70124

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

    Lecco, 23900

  • Ospedale San Carlo Borromeo, Via Pio II, 3

    Milan, 20153

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

    Pavia, 27100

Other trials in Italy

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego

    Gdansk, 80-211

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251

    Lodz, 92-213

  • Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18

    Olsztyn, 10-561

  • Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12

    Szczecin, 71-685

Other trials in Poland

Taiwan4 sites

  • Kaohsiung Medical Univ Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital, No 2 Yude Rd

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital, No 138 Sheng Li Rd

    Tainan, 704

Other trials in Taiwan

Finland3 sites

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

    Helsinki, 00290

  • Study Cor Oy, Hoitajantie 4

    Jyväskylä, 40620

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

    Tampere, 33520

Other trials in Finland

About this study

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)

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).

Read the 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.

Being tested
Nefecon, Placebo oral capsule
Keywords
IgA Nephropathy
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NefeconDrug

    Also called Budesonide modified released capsule

    Nefecon 16 mg for daily administration by mouth for 9 months.

  • Placebo oral capsuleDrug

    Also called Placebo

    Placebo capsules for daily administration by mouth for 9 months.

Study groups in NCT03643965
Study groupRoleWhat they receive
NefeconExperimentalNefecon 16 mg once daily by mouth for 9 months.
Receives: Drug: Nefecon
Placebo oral capsulePlacebo comparatorPlacebo oral capsule once daily by mouth for 9 months.
Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline

    Part A primary endpoint: The ratio of Urine Protein to Creatinine Ratio (UPCR) (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline.

    Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram

    Measured: 9 months

  2. Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR)

    Part B Primary endpoint: Time-weighted average of estimated glomerular filtration rate (eGFR) recordings observed at each time point over 2 years. The eGFR (CKD-EPI) at 2 years (which must have been repeated to provide a second value obtained within 14 to 35 days) was the geometric mean of the 2 assessments.

    Measured: Up to 2 years and 1 month

Secondary outcomes (11)

  1. Part A: Ratio of eGFR at 9 Months

    Part A: Ratio of eGFR at 9 months compared to baseline calculated using the CKD-EPI formula.

    Measured: 9 months

  2. Part A: Ratio of eGFR at 12 Months

    Part A: Ratio of eGFR at 12 months compared to baseline calculated using the CKD-EPI formula.

    Measured: 12 months

  3. Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months

    Part A: Ratio of urine albumin to creatinine ratio (UACR) at 9 months compared to baseline.

    Measured: 9 months

  4. Part B: Time to 30% Reduction in eGFR

    Part B: Time to 30% reduction from baseline in eGFR (CKD-EPI) confirmed by a second value.

    For clarity: Please note that the number of patients with a 30% reduction is presented with statistical analysis of the time to 30% reduction.

    Measured: Over 2 years

  5. Part B: Time to Receiving Rescue Medication.

    Part B: Time from the first dose of study drug until receiving rescue medication.

    For clarity: Please note that the number of patients receiving rescue medication is presented with statistical analysis of the time to receiving rescue medication.

    Measured: Over 2 years

  6. Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months

    Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug

    Measured: 12, 18 and 24 months

  7. Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months

    Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug.

    Measured: 12 to 24 months

  8. Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months

    Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug;

    Measured: 12 to 24 months

  9. Part B: Proportion of Patients Without Microhematuria

    Part B: Proportion of patients without microhematuria in at least 2 of the following time points: 12, 18, and 24 months following the first dose of study drug

    Measured: 12 to 24 months

  10. Part B: Short Form 36 (SF-36) Quality of Life Assessment at 9 Months.

    Part B: Short Form 36 (SF-36) quality of life assessment at 9 and 24 months.

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. It consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

    Higher scores indicate better health. Scores represent the percentage of total possible score achieved.

    Measured: 9 months

  11. Part B: Short Form 36 (SF-36) Quality of Life Assessment at 24 Months.

    Part B: Short Form 36 (SF-36) quality of life assessment at 9 and 24 months.

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. It consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

    Higher scores indicate better health. Scores represent the percentage of total possible score achieved.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2018
  2. Study start5 Sep 2018
  3. Primary completion10 Jul 2023
  4. Study completion10 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643965
Sponsor's protocol ID
Nef-301
Acronym
Nefigard
Status last verified
Nov 2024
First submitted
8 Aug 2018
Last updated
3 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28363480

  • 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.

    PubMed 39724565

  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nefecon in people with Primary IgA Nephropathy, run by Calliditas Therapeutics AB at 142 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Canada, United Kingdom, Australia, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643965, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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