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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nefecon | Experimental | Nefecon 16 mg once daily by mouth for 9 months. |
|
| Placebo oral capsule | Placebo Comparator | Placebo oral capsule once daily by mouth for 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nefecon | Drug | Nefecon 16 mg for daily administration by mouth for 9 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 months |
| 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. | Up to 2 years and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krassimir Mitchev, MD | Calliditas AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, 1720 2nd Ave South | Birmingham | Alabama | 35294-3412 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28363480 | Background | 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. | |
| 39724565 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nefecon | Nefecon 16 mg once daily by mouth for 9 months. Nefecon: Nefecon 16 mg for daily administration by mouth for 9 months. |
| FG001 | Placebo Oral Capsule | Placebo oral capsule once daily by mouth for 9 months. Placebo oral capsule: Placebo capsules for daily administration by mouth for 9 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2021 |
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| Placebo oral capsule | Drug | Placebo capsules for daily administration by mouth for 9 months. |
|
|
| 12 months |
| 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. | 9 months |
| 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. | Over 2 years |
| 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. | Over 2 years |
| 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 | 12, 18 and 24 months |
| 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. | 12 to 24 months |
| 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; | 12 to 24 months |
| 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 | 12 to 24 months |
| 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. | 9 months |
| 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. | 24 months |
| Univ of Arizona, 1501 N Campbell Ave |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Stanford University Medical Center, 777 Welch Rd | Palo Alto | California | 94304 | United States |
| Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street | Torrance | California | 90502 | United States |
| University of Colorado Health Science Center, 1200 East 19th Av. | Aurora | Colorado | 80045 | United States |
| Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St. | Westminster | Colorado | 80031 | United States |
| Yale University School of Medicine, 330 Cedar Street | New Haven | Connecticut | 06520 | United States |
| Washington Nephrology Associates-Washington DC, 730 24th Street NW | Washington D.C. | District of Columbia | 20037 | United States |
| University of Florida-Gainesville | Gainesville | Florida | 32610 | United States |
| Omega Research Maitland, 7912 Forest City Rd. | Orlando | Florida | 32810 | United States |
| Omega Research Maitland | Orlando | Florida | 32810 | United States |
| Northwestern University the Feinberg School of Medicine, 633 North St. Clair | Chicago | Illinois | 60611 | United States |
| Northshore University Health System, 2650 Ridge Av. | Evanston | Illinois | 60201 | United States |
| University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor | Lexington | Kentucky | 40536 | United States |
| University of Louisville-Nephrology | Louisville | Kentucky | 40202 | United States |
| Kidney Care and Transplant Services of New England, PC, 354 Birnie Av. | Springfield | Massachusetts | 01107 | United States |
| University of Minnesota, 717 Delaware St. SE | Minneapolis | Minnesota | 55414 | United States |
| Clinical Research Consultants, LLC, 3930 Washington St | Kansas City | Missouri | 64111 | United States |
| Queens Hospital Centre | Jamaica | New York | 11432 | United States |
| Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place | New York | New York | 10029 | United States |
| Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av | New York | New York | 10032 | United States |
| Mountain Kidney & Hypertension Assoc, 10 McDowell St | Asheville | North Carolina | 28801 | United States |
| University of North Carolina at Chapel Hill, Clinical & Translational Research Centre | Chapel Hill | North Carolina | 27599 | United States |
| Southeastern Nephrology-Whiteville, 800 Jefferson St | Whiteville | North Carolina | 28472 | United States |
| Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive | Wilmington | North Carolina | 28401 | United States |
| Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av. | Cleveland | Ohio | 44195 | United States |
| The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av. | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University, 3181 SW Sam Jackson Park Rd | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University, 211 S. 9th Street | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital, 4800 Friendship Av. | Pittsburgh | Pennsylvania | 15224 | United States |
| Nephrology Associates, P.C., 28 White Bridge Rd | Nashville | Tennessee | 37205 | United States |
| Renal Disease Research Institute, 1250 Eighth Av. #135 | Fort Worth | Texas | 76104 | United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| Hospital Britanico de Buenos Aires, Pedriel 74 | Capital Federal | C1280AEB | Argentina |
| Clinica Priv Velez Sarsfield | Córdoba | 5000 | Argentina |
| Hospital Privado-Centro Medico de Cordoba, Naciones Unidas 346, Nefrologia piso 1 | Córdoba | 5016 | Argentina |
| Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso | Córdoba | X5000JHQ | Argentina |
| Hospital Universitario Austral, Unidad de Investigacion Clinica, Av. J.D. Peron 1500, piso 4 | Pilar | B16290DT | Argentina |
| Clinico de Nefrologia, Urologia Y Enfermedades Cardiovasculares, Av. Gdor Freyre 3074 | Santa Fe | 3000 | Argentina |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Royal Adelaide Hospital, Port Rd. | Adelaide | 5000 | Australia |
| Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5 | Box Hill | 3128 | Australia |
| Austin Health, Dept of Nephrology, 145 Studley Rd. | Heidelberg | 3084 | Australia |
| Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str. | Parkville | 3052 | Australia |
| Prince of Wales Hospital, Nephrology Dept, Parkes 3 West | Randwick | 2031 | Australia |
| Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building | St Albans | 3021 | Australia |
| Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd. | Westmead | 2145 | Australia |
| Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd. | Woolloongabba | 4102 | Australia |
| Brest Regional Hospital, 7 Meditsinskaya str. | Brest | 224027 | Belarus |
| Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola | Grodno | 230030 | Belarus |
| Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str. | Homyel | 246029 | Belarus |
| 4-th N.E. Savchenko City Clinical Hospital, 110, R. Luxemburg str. | Minsk | 220036 | Belarus |
| University Hospital Erasmus (Brussels), Recherche Clinique Nephrologie Transplantation, Route de Lennik 808 | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc, Nephrology Dept, Av. Hippocrate 10 | Brussels | 1200 | Belgium |
| University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10 | Ghent | 9000 | Belgium |
| Centre Hospitalier Universitaire de Liege, Nephrology Dept. Domaine Universitaire de Sart-Tilman | Liège | 4000 | Belgium |
| AZ Delta, Wilgenstraat 2 | Roeselare | 8800 | Belgium |
| Royal Inland Hospital, Kidney Clinic, 7 South, 311 Columbia Street | Kamloops | British Columbia | V2C 2T1 | Canada |
| Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str. | Kelowna | British Columbia | V1Y 1T2 | Canada |
| Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building | Vancouver | British Columbia | V5T 3A5 | Canada |
| Queen Elizabeth II Health Sciences Centre, 1276 South Park St | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L2V7 | Canada |
| Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue | Toronto | Ontario | M4G 3E8 | Canada |
| Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849 | Toronto | Ontario | M5G2C4 | Canada |
| CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd | Greenfield Park | Quebec | J4V 2H1 | Canada |
| CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais | Québec | Quebec | G1R 2J6 | Canada |
| Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20 | Brno | 62500 | Czechia |
| Fakultni nemocnice Hradec Kralove, Sokolska 581 | Hradec Králové | 50005 | Czechia |
| Fakultni nemocnice Olomouc, I.P. Pavlova 185/6 | Olomouc | 77900 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady, Linterni klinika, Srobarova 1150/50 | Prague | 10034 | Czechia |
| Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2 | Prague | 12808 | Czechia |
| Helsinki University Central Hospital (HUCH), Nephrology Clinic, Meilahti Triangle Hospital | Helsinki | 00290 | Finland |
| Study Cor Oy, Hoitajantie 4 | Jyväskylä | 40620 | Finland |
| Tampere University Hospital, P O Box 2000, Munuaiskeskus, Erakennus, 1. kerros | Tampere | 33520 | Finland |
| Centre Hospitalier Boulogne sur Mer, 4eme etage Batiment Administratif, Allee Jacques Monod | Boulogne-sur-Mer | 62321 | France |
| CHU Grenoble-Hopital Michallon, Service Nephrologie-Hemodialyse-Aphereses-Transplantation Renale, Boulevard de la Chantourne CS 10217 | Grenoble | 30043 | France |
| Lapeyronie Hospital, Univ Hospital Montpellier, 371 Av. du Doyen Gaston Giraud | Montpellier | 34295 | France |
| Hopital Bichat-Claude Bernard, Service de Nephrologie, 46 rue Henri Huchard | Paris | 75877 | France |
| Chu St Etienne-Hopital Nord, Service de Nephrologie Dialyse Transplantation renale, Av. Albert Raimond | Saint-Priest-en-Jarez | 42270 | France |
| Centre Hospitalier de Valenciennes, Service de Nephrologie-Medecine Interne, Av. Desandrouin BP 379 | Valenciennes | 59322 | France |
| Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30 | Aachen | 52074 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden, Medizinische Klinik III, Nephrologie, Fetscherstr. 74 | Dresden | 01307 | Germany |
| Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18 | Erlangen | 91054 | Germany |
| Universitaetsklinikum Heidelberg-Nephrologie, Renal Clinic, Im Neuenheimer Feld 162 | Heidelberg | 69120 | Germany |
| Universitatsklinik Schleswig-Holstein-Campus Lubek, Medizinische Klinik I, Nephrologie, Ratzeburger Allee 160 | Lübeck | 23538 | Germany |
| University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV | Munich | 80336 | Germany |
| Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11 | Regensburg | 93053 | Germany |
| General Hospital of Athens-Laiko, Nephrology Clinic, 17 Agiou Thoma Street | Athens | 11527 | Greece |
| University Hospital of Heraklion, Nephrology Clinic, Diastaurosi Staurakion-Vouton | Heraklion | 71100 | Greece |
| University General Hospital of Ioannina, Nephrology Clinic, Leof. Stavros Niarchou | Ioannina | 45110 | Greece |
| University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo | Larissa | 41110 | Greece |
| General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str. | Nikaia | 18454 | Greece |
| University General Hospital of Patras, Rio | Pátrai | 26504 | Greece |
| Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str | Thessaloniki | 54642 | Greece |
| Azienda Ospedale Policlinico di Bari | Bari | 70124 | Italy |
| ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11 | Lecco | 23900 | Italy |
| Ospedale San Carlo Borromeo, Via Pio II, 3 | Milan | 20153 | Italy |
| Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10 | Pavia | 27100 | Italy |
| Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego | Gdansk | 80-211 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251 | Lodz | 92-213 | Poland |
| Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18 | Olsztyn | 10-561 | Poland |
| Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12 | Szczecin | 71-685 | Poland |
| Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu | Busan | 49201 | South Korea |
| Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu | Daegu | 41944 | South Korea |
| Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu | Daejeon | 35015 | South Korea |
| Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si | Gyeonggi-do | 14068 | South Korea |
| Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu | Seoul | 03080 | South Korea |
| Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu | Seoul | 06591 | South Korea |
| Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu | Seoul | 06973 | South Korea |
| Hospital Universitario Fundacion Alcorcon, C/Budapest 1 | Alcorcón | 28922 | Spain |
| Hospital del Mar, Passeig Maritim 25-29 | Barcelona | 08003 | Spain |
| Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129 | Barcelona | 08035 | Spain |
| Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170 | Barcelona | 08036 | Spain |
| Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80 | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46 | Madrid | 28007 | Spain |
| Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n | Madrid | 28041 | Spain |
| Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12 | Gothenburg | 41345 | Sweden |
| Universitetssjukhuset Linköping, Njurmedicinska kliniken | Linköping | 58185 | Sweden |
| Karolinska University Hospital-Huddinge, Njur-KBC M87 | Stockholm | 14186 | Sweden |
| Danderyds sjukhus, Njurmedicinska kliniken | Stockholm | 18288 | Sweden |
| Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5 | Uppsala | 75185 | Sweden |
| Kaohsiung Medical Univ Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| China Medical University Hospital, No 2 Yude Rd | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital, No 138 Sheng Li Rd | Tainan | 704 | Taiwan |
| Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali | Adana | 01330 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53 | Istanbul | 34098 | Turkey (Türkiye) |
| Ege University Med Faculty Dept of Internal Disease, Div of Nephrology | Izmir | 35100 | Turkey (Türkiye) |
| Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42 | Kayseri | 38039 | Turkey (Türkiye) |
| Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi | Kocaeli | 41000 | Turkey (Türkiye) |
| Belfast City Hospital, 51 Lisburn Rd | Belfast | BT9 7AB | United Kingdom |
| Southmead Hospital, Southmead Rd, Westbury-on-Trym | Bristol | BS10 5NB | United Kingdom |
| Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences | Glasgow | G51 4TF | United Kingdom |
| Gloucestershire Royal Hospital, Great Western Rd | Gloucester | GL1 3NN | United Kingdom |
| St James´s University Hospital, Beckett St. | Leeds | LS9 7TF | United Kingdom |
| Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd | Leicester | LE5 4PW | United Kingdom |
| The Royal London Hospital, Whitechapel | London | E1 1BB | United Kingdom |
| University of Manchester, Manchester Royal Infirmary, Oxford Rd | Manchester | M13 9WL | United Kingdom |
| Nottingham City Hospital, Hucknall Rd | Nottingham | NG5 1PB | United Kingdom |
| Northern General Hospital, Herries Rd. | Sheffield | S5 7AU | United Kingdom |
| Derived |
| 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. |
| 37591292 | Derived | 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. |
| 36685528 | Derived | 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. |
| 36270561 | Derived | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Part B |
|
Full analysis set - Global study
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nefecon | Nefecon 16 mg once daily by mouth for 9 months. Nefecon: Nefecon 16 mg for daily administration by mouth for 9 months. |
| BG001 | Placebo Oral Capsule | Placebo oral capsule once daily by mouth for 9 months. Placebo oral capsule: Placebo capsules for daily administration by mouth for 9 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Urine protein to creatinine ratio (UPCR) | Geometric Mean | Inter-Quartile Range | g/gram |
| |||||||||||||||
| Baseline Estimated glomerular filtration rate (eGFR) | Geometric Mean | Inter-Quartile Range | ml/min/1.73 m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Full analysis set - global study - Part A | Posted | Geometric Least Squares Mean | 96% Confidence Interval | ratio | 9 months |
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| Primary | 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. | Full analysis set - global study - Part B | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mL/min/1.73m2 | Up to 2 years and 1 month |
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| Secondary | 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. | Full analysis set - global study - Part A | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mL/min/1.73m2 | 9 months |
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| Secondary | 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. | Full analysis set - global study - Part A | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mL/min/1.73m2 | 12 months |
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| Secondary | 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. | Full analysis set - global study - Part A | Posted | Geometric Least Squares Mean | 95% Confidence Interval | g/gram | 9 months |
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| Secondary | 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. | Full analysis set - global study - Part B | Posted | Number | Participants | Over 2 years |
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| Secondary | 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. | Full analysis set - global study - Part B | Posted | Number | Participants | Over 2 years |
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| Secondary | 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 | Full analysis set - global study - Part B | Posted | Geometric Least Squares Mean | 95% Confidence Interval | g/gram | 12, 18 and 24 months |
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| Secondary | 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. | Full analysis set - global study - Part B | Posted | Geometric Least Squares Mean | 95% Confidence Interval | g/gram | 12 to 24 months |
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| Secondary | 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; | Full analysis set - global study - Part B | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mL/min/1.73m2 | 12 to 24 months |
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| Secondary | 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 | Full analysis set - global study - Part B | Posted | Count of Participants | Participants | 12 to 24 months |
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| Secondary | 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. | Full analysis set - global study - Part B | Posted | Mean | Standard Deviation | Percentage of total possible score | 9 months |
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| Secondary | 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. | Full analysis set - global study - Part B | Posted | Mean | Standard Deviation | Percentage of total possible score | 24 months |
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AEs were recorded from time of first dose of study treatment until 2 years after first dose (end of study). Treatment emergent AEs were those that occurred after the first dose of study drug until 14 days after the last dose, including tapering. SAEs were recorded from time of patient informed consent until end of study, i.e until 2 years and 3 months (including follow-up period)
Treatment emergent SAEs are listed on Clinicaltrial.gov.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nefecon | Nefecon 16 mg once daily by mouth for 9 months. Nefecon: Nefecon 16 mg for daily administration by mouth for 9 months. | 1 | 182 | 18 | 182 | 108 | 182 |
| EG001 | Placebo Oral Capsule | Placebo oral capsule once daily by mouth for 9 months. Placebo oral capsule: Placebo capsules for daily administration by mouth for 9 months. | 0 | 182 | 9 | 182 | 69 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corona virus infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Campylobacter colitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Hypertensive urgency | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Post thrombotic syndrome | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Bone marrow oedema | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 22.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema peripheral | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Headache | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Weight increased | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Leader | Calliditas Therapeutics | 0737456451 | kristin.onnestam@calliditas.com |
| Jun 17, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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