[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100359082":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":42,"centralContacts":46,"locations":54,"responsibleParty":531,"collaborators":50,"id":533,"slug":534,"hasResults":535,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":50,"eligibilityCriteria":539,"healthyVolunteers":535,"sex":540,"minAge":541,"maxAge":542,"enrollmentInfo":543,"targetDuration":50,"studyType":546,"phases":547,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":57,"whyStopped":50,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":571},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A: participants with native kidneys from CLNP023X2202","EXPERIMENTAL","C3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d",[13],"Drug: LNP023",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202","C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301","Native C3G Participants (adults and adolescents) from CLNP023B12301 study who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301","Native C3G participants (adults and adolescents) from study CLNP023B12301 who were randomized to iptacopan in the core study. Receiving iptacopan capsules 200mg b.i.d",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302","IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302","IC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to iptacopan in the core study receiving iptacopan capsules 200mg b.i.d",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","LNP023","LNP023 capsules",[9,15,19,23,27,31],[41],"iptacopan",[43],{"name":44,"affiliation":44,"role":45},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[47,52],{"name":44,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","1-888-669-6682",null,"novartis.email@novartis.com",{"name":44,"role":48,"phone":53,"phoneExt":50,"email":50},"+41613241111",[55,77,94,111,127,143,150,157,168,177,186,195,202,210,222,232,240,249,259,267,275,285,293,301,309,314,322,332,337,348,356,367,376,385,394,398,407,415,426,437,445,453,458,466,476,486,495,504,515,523],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Childrens Hospital Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-104.83192,39.72943,{"lat":67,"lon":66},[70,74],{"name":71,"role":48,"phone":72,"phoneExt":50,"email":73},"Kati Dugan","+1 720 777 6895","Kati.Dugan@childrenscolorado.org",{"name":75,"role":76,"phone":50,"phoneExt":50,"email":50},"Bradley Dixon","PRINCIPAL_INVESTIGATOR",{"facility":78,"status":57,"city":79,"state":80,"zip":81,"country":61,"countryCode":62,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Georgia Nephrology Research Inst","Lawrenceville","Georgia","30046",{"type":64,"coordinates":83},[84,85],-83.98796,33.95621,{"lat":85,"lon":84},[88,92],{"name":89,"role":48,"phone":90,"phoneExt":50,"email":91},"Lisa Franklin","+1 404 645 7850#3024","lfranklin@ganephrology.com",{"name":93,"role":76,"phone":50,"phoneExt":50,"email":50},"James A Tumlin",{"facility":95,"status":57,"city":96,"state":97,"zip":98,"country":61,"countryCode":62,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"University of Iowa Health Care","Iowa City","Iowa","52242-1091",{"type":64,"coordinates":100},[101,102],-91.53017,41.66113,{"lat":102,"lon":101},[105,109],{"name":106,"role":48,"phone":107,"phoneExt":50,"email":108},"Nicole Gerot","+1 319 335 7555","nicole-gerot@uiowa.edu",{"name":110,"role":76,"phone":50,"phoneExt":50,"email":50},"Carla Nester",{"facility":112,"status":57,"city":113,"state":114,"zip":115,"country":61,"countryCode":62,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"University of Minnesota","Minneapolis","Minnesota","55455",{"type":64,"coordinates":117},[118,119],-93.26384,44.97997,{"lat":119,"lon":118},[122,125],{"name":123,"role":48,"phone":50,"phoneExt":50,"email":124},"Brady Wallner","walln080@umn.edu",{"name":126,"role":76,"phone":50,"phoneExt":50,"email":50},"Nattawat Klomjit",{"facility":128,"status":57,"city":129,"state":129,"zip":130,"country":61,"countryCode":62,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Col Uni Med Center New York Presby","New York","10032",{"type":64,"coordinates":132},[133,134],-74.00597,40.71427,{"lat":134,"lon":133},[137,141],{"name":138,"role":48,"phone":139,"phoneExt":50,"email":140},"Brianna Ortiz","+1 212 304 5684","bo2323@cumc.columbia.edu",{"name":142,"role":76,"phone":50,"phoneExt":50,"email":50},"Andrew S Bomback",{"facility":144,"status":57,"city":145,"state":146,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":50,"geoPoint":50,"contacts":50},"Novartis Investigative Site","CABA","Buenos Aires","C1425AGC","Argentina","AR",{"facility":144,"status":57,"city":146,"state":50,"zip":151,"country":148,"countryCode":149,"cosmosGeoPoint":152,"geoPoint":156,"contacts":50},"W3400ABH",{"type":64,"coordinates":153},[154,155],-58.37723,-34.61315,{"lat":155,"lon":154},{"facility":144,"status":57,"city":158,"state":159,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":50},"Belo Horizonte","Minas Gerais","30150-221","Brazil","BR",{"type":64,"coordinates":164},[165,166],-43.93778,-19.92083,{"lat":166,"lon":165},{"facility":144,"status":57,"city":169,"state":170,"zip":171,"country":161,"countryCode":162,"cosmosGeoPoint":172,"geoPoint":176,"contacts":50},"Recife","Pernambuco","50740-900",{"type":64,"coordinates":173},[174,175],-34.88111,-8.05389,{"lat":175,"lon":174},{"facility":144,"status":57,"city":178,"state":179,"zip":180,"country":161,"countryCode":162,"cosmosGeoPoint":181,"geoPoint":185,"contacts":50},"Porto Alegre","Rio Grande do Sul","90035-074",{"type":64,"coordinates":182},[183,184],-51.23019,-30.03283,{"lat":184,"lon":183},{"facility":144,"status":57,"city":187,"state":188,"zip":189,"country":161,"countryCode":162,"cosmosGeoPoint":190,"geoPoint":194,"contacts":50},"Botucatu","São Paulo","3880-1001",{"type":64,"coordinates":191},[192,193],-48.445,-22.88583,{"lat":193,"lon":192},{"facility":144,"status":57,"city":188,"state":188,"zip":196,"country":161,"countryCode":162,"cosmosGeoPoint":197,"geoPoint":201,"contacts":50},"04038-002",{"type":64,"coordinates":198},[199,200],-46.63611,-23.5475,{"lat":200,"lon":199},{"facility":144,"status":57,"city":203,"state":50,"zip":204,"country":161,"countryCode":162,"cosmosGeoPoint":205,"geoPoint":209,"contacts":50},"Salvador","40323-010",{"type":64,"coordinates":206},[207,208],-38.49096,-12.97563,{"lat":208,"lon":207},{"facility":144,"status":211,"city":212,"state":213,"zip":214,"country":215,"countryCode":216,"cosmosGeoPoint":217,"geoPoint":221,"contacts":50},"ACTIVE_NOT_RECRUITING","Toronto","Ontario","M5G 2C4","Canada","CA",{"type":64,"coordinates":218},[219,220],-79.39864,43.70643,{"lat":220,"lon":219},{"facility":144,"status":57,"city":223,"state":50,"zip":224,"country":225,"countryCode":226,"cosmosGeoPoint":227,"geoPoint":231,"contacts":50},"Beijing","100034","China","CN",{"type":64,"coordinates":228},[229,230],116.39723,39.9075,{"lat":230,"lon":229},{"facility":144,"status":57,"city":233,"state":50,"zip":234,"country":225,"countryCode":226,"cosmosGeoPoint":235,"geoPoint":239,"contacts":50},"Shanghai","200040",{"type":64,"coordinates":236},[237,238],121.45806,31.22222,{"lat":238,"lon":237},{"facility":144,"status":211,"city":241,"state":50,"zip":242,"country":243,"countryCode":50,"cosmosGeoPoint":244,"geoPoint":248,"contacts":50},"Prague","128 08","Czechia",{"type":64,"coordinates":245},[246,247],14.42076,50.08804,{"lat":247,"lon":246},{"facility":144,"status":57,"city":250,"state":50,"zip":251,"country":252,"countryCode":253,"cosmosGeoPoint":254,"geoPoint":258,"contacts":50},"Montpellier","34295","France","FR",{"type":64,"coordinates":255},[256,257],3.87635,43.61093,{"lat":257,"lon":256},{"facility":144,"status":57,"city":260,"state":50,"zip":261,"country":252,"countryCode":253,"cosmosGeoPoint":262,"geoPoint":266,"contacts":50},"Paris","75015",{"type":64,"coordinates":263},[264,265],2.3488,48.85341,{"lat":265,"lon":264},{"facility":144,"status":57,"city":268,"state":50,"zip":269,"country":252,"countryCode":253,"cosmosGeoPoint":270,"geoPoint":274,"contacts":50},"Toulouse","31054",{"type":64,"coordinates":271},[272,273],1.44367,43.60426,{"lat":273,"lon":272},{"facility":144,"status":211,"city":276,"state":50,"zip":277,"country":278,"countryCode":279,"cosmosGeoPoint":280,"geoPoint":284,"contacts":50},"Erlangen","91054","Germany","DE",{"type":64,"coordinates":281},[282,283],11.00783,49.59099,{"lat":283,"lon":282},{"facility":144,"status":57,"city":286,"state":50,"zip":287,"country":278,"countryCode":279,"cosmosGeoPoint":288,"geoPoint":292,"contacts":50},"Essen","45147",{"type":64,"coordinates":289},[290,291],7.01228,51.45657,{"lat":291,"lon":290},{"facility":144,"status":57,"city":294,"state":50,"zip":295,"country":278,"countryCode":279,"cosmosGeoPoint":296,"geoPoint":300,"contacts":50},"Hamburg","20246",{"type":64,"coordinates":297},[298,299],9.99302,53.55073,{"lat":299,"lon":298},{"facility":144,"status":57,"city":302,"state":50,"zip":303,"country":278,"countryCode":279,"cosmosGeoPoint":304,"geoPoint":308,"contacts":50},"Mainz","55131",{"type":64,"coordinates":305},[306,307],8.28008,49.98185,{"lat":307,"lon":306},{"facility":144,"status":57,"city":310,"state":50,"zip":311,"country":312,"countryCode":313,"cosmosGeoPoint":50,"geoPoint":50,"contacts":50},"Heraklion Crete.","715 00","Greece","GR",{"facility":144,"status":57,"city":315,"state":50,"zip":316,"country":312,"countryCode":313,"cosmosGeoPoint":317,"geoPoint":321,"contacts":50},"Thessaloniki","546 42",{"type":64,"coordinates":318},[319,320],22.93493,40.64072,{"lat":320,"lon":319},{"facility":144,"status":57,"city":323,"state":50,"zip":324,"country":325,"countryCode":326,"cosmosGeoPoint":327,"geoPoint":331,"contacts":50},"Petah Tikva","4920235","Israel","IL",{"type":64,"coordinates":328},[329,330],34.88747,32.08707,{"lat":330,"lon":329},{"facility":144,"status":57,"city":323,"state":50,"zip":333,"country":325,"countryCode":326,"cosmosGeoPoint":334,"geoPoint":336,"contacts":50},"4941492",{"type":64,"coordinates":335},[329,330],{"lat":330,"lon":329},{"facility":144,"status":57,"city":338,"state":339,"zip":340,"country":341,"countryCode":342,"cosmosGeoPoint":343,"geoPoint":347,"contacts":50},"Ranica","BG","24020","Italy","IT",{"type":64,"coordinates":344},[345,346],9.71335,45.72328,{"lat":346,"lon":345},{"facility":144,"status":57,"city":349,"state":50,"zip":350,"country":341,"countryCode":342,"cosmosGeoPoint":351,"geoPoint":355,"contacts":50},"Roma","165",{"type":64,"coordinates":352},[353,354],11.10642,44.99364,{"lat":354,"lon":353},{"facility":144,"status":211,"city":357,"state":358,"zip":359,"country":360,"countryCode":361,"cosmosGeoPoint":362,"geoPoint":366,"contacts":50},"Nagoya","Aichi-ken","4668560","Japan","JP",{"type":64,"coordinates":363},[364,365],136.90641,35.18147,{"lat":365,"lon":364},{"facility":144,"status":211,"city":368,"state":369,"zip":370,"country":360,"countryCode":361,"cosmosGeoPoint":371,"geoPoint":375,"contacts":50},"Asahikawa","Hokkaido","0788510",{"type":64,"coordinates":372},[373,374],142.36489,43.77063,{"lat":374,"lon":373},{"facility":144,"status":377,"city":378,"state":369,"zip":379,"country":360,"countryCode":361,"cosmosGeoPoint":380,"geoPoint":384,"contacts":50},"COMPLETED","Sapporo","0608543",{"type":64,"coordinates":381},[382,383],141.35,43.06667,{"lat":383,"lon":382},{"facility":144,"status":211,"city":386,"state":387,"zip":388,"country":360,"countryCode":361,"cosmosGeoPoint":389,"geoPoint":393,"contacts":50},"Takatsuki","Osaka","5691192",{"type":64,"coordinates":390},[391,392],135.61678,34.84833,{"lat":392,"lon":391},{"facility":144,"status":57,"city":395,"state":396,"zip":397,"country":360,"countryCode":361,"cosmosGeoPoint":50,"geoPoint":50,"contacts":50},"Ohtsu","Shiga","5202192",{"facility":144,"status":57,"city":399,"state":400,"zip":401,"country":360,"countryCode":361,"cosmosGeoPoint":402,"geoPoint":406,"contacts":50},"Hachiōji","Tokyo","193-0998",{"type":64,"coordinates":403},[404,405],139.32389,35.65583,{"lat":405,"lon":404},{"facility":144,"status":211,"city":408,"state":50,"zip":409,"country":360,"countryCode":361,"cosmosGeoPoint":410,"geoPoint":414,"contacts":50},"Niigata","9518520",{"type":64,"coordinates":411},[412,413],139.04125,37.92259,{"lat":413,"lon":412},{"facility":144,"status":57,"city":416,"state":417,"zip":418,"country":419,"countryCode":420,"cosmosGeoPoint":421,"geoPoint":425,"contacts":50},"Leiden","South Holland","2333 ZA","Netherlands","NL",{"type":64,"coordinates":422},[423,424],4.49306,52.15833,{"lat":424,"lon":423},{"facility":144,"status":57,"city":427,"state":428,"zip":429,"country":430,"countryCode":431,"cosmosGeoPoint":432,"geoPoint":436,"contacts":50},"Pamplona","Navarre","31008","Spain","ES",{"type":64,"coordinates":433},[434,435],-1.64323,42.81687,{"lat":435,"lon":434},{"facility":144,"status":211,"city":438,"state":50,"zip":439,"country":430,"countryCode":431,"cosmosGeoPoint":440,"geoPoint":444,"contacts":50},"Barcelona","08035",{"type":64,"coordinates":441},[442,443],2.15899,41.38879,{"lat":443,"lon":442},{"facility":144,"status":57,"city":446,"state":50,"zip":447,"country":430,"countryCode":431,"cosmosGeoPoint":448,"geoPoint":452,"contacts":50},"Madrid","28040",{"type":64,"coordinates":449},[450,451],-3.70256,40.4165,{"lat":451,"lon":450},{"facility":144,"status":57,"city":446,"state":50,"zip":454,"country":430,"countryCode":431,"cosmosGeoPoint":455,"geoPoint":457,"contacts":50},"28041",{"type":64,"coordinates":456},[450,451],{"lat":451,"lon":450},{"facility":144,"status":57,"city":459,"state":50,"zip":460,"country":430,"countryCode":431,"cosmosGeoPoint":461,"geoPoint":465,"contacts":50},"Seville","41009",{"type":64,"coordinates":462},[463,464],-5.97317,37.38283,{"lat":464,"lon":463},{"facility":144,"status":57,"city":467,"state":50,"zip":468,"country":469,"countryCode":470,"cosmosGeoPoint":471,"geoPoint":475,"contacts":50},"Bern","3010","Switzerland","CH",{"type":64,"coordinates":472},[473,474],7.44744,46.94809,{"lat":474,"lon":473},{"facility":144,"status":57,"city":477,"state":478,"zip":479,"country":480,"countryCode":50,"cosmosGeoPoint":481,"geoPoint":485,"contacts":50},"Köseköy","Kocaeli","41380","Turkey (Türkiye)",{"type":64,"coordinates":482},[483,484],30.00556,40.74012,{"lat":484,"lon":483},{"facility":144,"status":57,"city":487,"state":488,"zip":489,"country":480,"countryCode":50,"cosmosGeoPoint":490,"geoPoint":494,"contacts":50},"Kayseri","Melikgazi","38039",{"type":64,"coordinates":491},[492,493],35.48528,38.73222,{"lat":493,"lon":492},{"facility":144,"status":57,"city":496,"state":497,"zip":498,"country":480,"countryCode":50,"cosmosGeoPoint":499,"geoPoint":503,"contacts":50},"Ankara","Yenimahalle","06500",{"type":64,"coordinates":500},[501,502],32.85427,39.91987,{"lat":502,"lon":501},{"facility":144,"status":57,"city":505,"state":506,"zip":507,"country":508,"countryCode":509,"cosmosGeoPoint":510,"geoPoint":514,"contacts":50},"Newcastle upon Tyne","Tyne and Wear","NE7 7DN","United Kingdom","UK",{"type":64,"coordinates":511},[512,513],-1.61396,54.97328,{"lat":513,"lon":512},{"facility":144,"status":57,"city":516,"state":50,"zip":517,"country":508,"countryCode":509,"cosmosGeoPoint":518,"geoPoint":522,"contacts":50},"Cardiff","CF14 4XW",{"type":64,"coordinates":519},[520,521],-3.18,51.48,{"lat":521,"lon":520},{"facility":144,"status":57,"city":524,"state":50,"zip":525,"country":508,"countryCode":509,"cosmosGeoPoint":526,"geoPoint":530,"contacts":50},"London","W12 0HS",{"type":64,"coordinates":527},[528,529],-0.12574,51.50853,{"lat":529,"lon":528},{"type":532,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100359082","phase-3-long-term-efficacy-safety-and-tolerability-of-iptacopan-in-c3g-or-ic-mpgn-100359082",false,"NCT03955445","Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN","An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis","Inclusion Criteria:\n\n\\- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug\n\nExclusion Criteria:\n\n* Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.\n* History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects\n* History of HIV or any other immunodeficiency disease\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","12 Years","100 Years",{"count":544,"type":545},225,"ESTIMATED","INTERVENTIONAL",[548],"PHASE3","This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis",[551,552],"C3 Glomerulopathy","Immune-complex-membranoproliferative Glomerulonephritis",[554,555,556,557,558,559,41,37,560,561],"C3G","C3 glomerulopathy","C3GN","C3 glomerulonephritis","DDD","dense deposit disease","IC-MPGN","idiopathic immune-complex- membranoproliferative glomerulonephritis","2026-04-09",{"date":564,"type":565},"2026-04-14","ACTUAL",{"date":567,"type":565},"2019-10-03",{"date":569,"type":545},"2036-05-30",{"name":44,"class":6},50]