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

November 25, 2024 updated by: Calliditas Therapeutics AB

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline
Time Frame: 9 months

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
9 months
Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Up to 2 years and 1 month
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.
Up to 2 years and 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Ratio of eGFR at 9 Months
Time Frame: 9 months
Part A: Ratio of eGFR at 9 months compared to baseline calculated using the CKD-EPI formula.
9 months
Part A: Ratio of eGFR at 12 Months
Time Frame: 12 months
Part A: Ratio of eGFR at 12 months compared to baseline calculated using the CKD-EPI formula.
12 months
Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months
Time Frame: 9 months
Part A: Ratio of urine albumin to creatinine ratio (UACR) at 9 months compared to baseline.
9 months
Part B: Time to 30% Reduction in eGFR
Time Frame: Over 2 years

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.
Over 2 years
Part B: Time to Receiving Rescue Medication.
Time Frame: Over 2 years

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.
Over 2 years
Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months
Time Frame: 12, 18 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
12, 18 and 24 months
Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months
Time Frame: 12 to 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.
12 to 24 months
Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months
Time Frame: 12 to 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;
12 to 24 months
Part B: Proportion of Patients Without Microhematuria
Time Frame: 12 to 24 months
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
12 to 24 months
Part B: Short Form 36 (SF-36) Quality of Life Assessment at 9 Months.
Time Frame: 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.
9 months
Part B: Short Form 36 (SF-36) Quality of Life Assessment at 24 Months.
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Calliditas Therapeutics AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Krassimir Mitchev, MD, Calliditas AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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