[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412703":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":435,"collaborators":437,"id":441,"slug":442,"hasResults":443,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":443,"sex":449,"minAge":450,"maxAge":26,"enrollmentInfo":451,"targetDuration":26,"studyType":454,"phases":455,"briefSummary":457,"conditions":458,"keywords":462,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rheopheresis group","EXPERIMENTAL","In addition to the standards of care, the experimental group will carry out the rheopheresis in two stages:\n\n* Stage 1: induction treatment: 3 apheresis sessions during the first week (w0; i.e. between D1 and D7) and then 2 apheresis sessions each week for 3 weeks (from w1 to w3; i.e. between D8 and D28) ;\n* Step 2: maintenance treatment with 1 apheresis session per week until the 11th week (i.e. between D29 and D84).",[13],"Procedure: Rheopheresis procedure",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham-apheresis group","SHAM_COMPARATOR","In addition to the standards of care, the comparator group will carry out Sham-apheresis sessions according to the same scheme as the rheopheresis sessions of the experimental group.",[19],"Procedure: Sham-apheresis",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Rheopheresis procedure","rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham-apheresis","Sham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient.",[15],[32],{"name":33,"affiliation":5,"role":34},"Arnaud Lionet, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","0320445000","+33","arnaud.lionet@chru-lille.fr",[42,60,75,89,103,117,131,145,159,173,186,200,214,227,237,251,265,276,289,300,314,328,342,355,369,380,394,408,421],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"CHU d'Angers","NOT_YET_RECRUITING","Angers","49933","France","FR",{"type":50,"coordinates":51},"Point",[52,53],-0.55202,47.47156,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":26,"email":59},"Anne-Sophie Garnier, Dr","02 41 35 50 63","annesophie.garnier@chu-angers.fr",{"facility":61,"status":62,"city":63,"state":26,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"CHU d'Arras","RECRUITING","Arras","62022",{"type":50,"coordinates":66},[67,68],2.78186,50.29301,{"lat":68,"lon":67},[71],{"name":72,"role":37,"phone":73,"phoneExt":26,"email":74},"Amr EKHLAS, Dr","03 21 21 14 40","amr.ekhlas@gh-artoisternois.fr",{"facility":76,"status":44,"city":77,"state":26,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU d'Auxerre","Auxerre","89011",{"type":50,"coordinates":80},[81,82],3.57033,47.7996,{"lat":82,"lon":81},[85],{"name":86,"role":37,"phone":87,"phoneExt":26,"email":88},"Rachid Bourouma, Dr","03 86 48 47 16","rbourouma@ch-auxerre.fr",{"facility":90,"status":62,"city":91,"state":26,"zip":92,"country":47,"countryCode":48,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"CHU de Besançon, Hôpital Jean Minjoz","Besançon","25000",{"type":50,"coordinates":94},[95,96],6.01815,47.24878,{"lat":96,"lon":95},[99],{"name":100,"role":37,"phone":101,"phoneExt":26,"email":102},"Thomas CREPIN, Dr","03 81 21 82 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Bordeaux","Bourdeaux","33076",{"type":50,"coordinates":136},[137,138],5.13611,44.58582,{"lat":138,"lon":137},[141],{"name":142,"role":37,"phone":143,"phoneExt":26,"email":144},"M Yahsou Delmas, Dr","05 56 79 58 31","yahsou.delmas@chu-bordeaux.fr",{"facility":146,"status":44,"city":147,"state":26,"zip":148,"country":47,"countryCode":48,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"CHRU de Brest","Brest","29609",{"type":50,"coordinates":150},[151,152],-4.48628,48.39029,{"lat":152,"lon":151},[155],{"name":156,"role":37,"phone":157,"phoneExt":26,"email":158},"Isabelle SEGALEN, Dr","02 98 34 25 33","isabelle.segalen@chu-brest.fr",{"facility":160,"status":44,"city":161,"state":26,"zip":162,"country":47,"countryCode":48,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"CHU de Caen","Caen","14033",{"type":50,"coordinates":164},[165,166],-0.35912,49.18585,{"lat":166,"lon":165},[169],{"name":170,"role":37,"phone":171,"phoneExt":26,"email":172},"Patrick Henri, Dr","02 31 27 23 43","henri-p@chu-caen.fr",{"facility":174,"status":62,"city":175,"state":26,"zip":176,"country":47,"countryCode":48,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Hôpital Nord Michallon, CHU de Grenoble","Grenoble","38043",{"type":50,"coordinates":178},[179,180],5.71479,45.17869,{"lat":180,"lon":179},[183],{"name":184,"role":37,"phone":26,"phoneExt":26,"email":185},"Lionel ROSTAING, Pr","lrostaing@chu-grenoble.fr",{"facility":187,"status":62,"city":188,"state":26,"zip":189,"country":47,"countryCode":48,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Centre ECHO Laval","Laval","53015",{"type":50,"coordinates":191},[192,193],-0.77019,48.07247,{"lat":193,"lon":192},[196],{"name":197,"role":37,"phone":198,"phoneExt":26,"email":199},"Wael EL HAGGAN, Dr","02 43 66 39 52","welhagga@echo-sante.com",{"facility":201,"status":62,"city":202,"state":26,"zip":203,"country":47,"countryCode":48,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Centre ECHO Le Mans","Le Mans","72000",{"type":50,"coordinates":205},[206,207],0.20251,48.0021,{"lat":207,"lon":206},[210],{"name":211,"role":37,"phone":212,"phoneExt":26,"email":213},"Guillaume SERET, Dr","02 43 78 38 79","gseret@echo-sante.com",{"facility":215,"status":62,"city":216,"state":26,"zip":217,"country":47,"countryCode":48,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Hôpital Privé La Louvière","Lille","59000",{"type":50,"coordinates":219},[220,221],3.05512,50.63391,{"lat":221,"lon":220},[224],{"name":225,"role":37,"phone":226,"phoneExt":26,"email":26},"Laurence VRIGNEAUD, Dr","03 20 15 71 31",{"facility":228,"status":62,"city":216,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"Hop Claude Huriez Chu Lille",{"type":50,"coordinates":230},[220,221],{"lat":221,"lon":220},[233],{"name":234,"role":37,"phone":235,"phoneExt":26,"email":236},"Arnaud Lionet, Dr","03 20 44 50 00","arnaud.lionet@chu-lille.fr",{"facility":238,"status":62,"city":239,"state":26,"zip":240,"country":47,"countryCode":48,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"CHR de Limoges","Limoges","87042",{"type":50,"coordinates":242},[243,244],1.24759,45.83362,{"lat":244,"lon":243},[247],{"name":248,"role":37,"phone":249,"phoneExt":26,"email":250},"Zhour El Ouafi, Dr","06 80 26 75 81","zhour.elouafi@chu-limoges.fr",{"facility":252,"status":44,"city":253,"state":26,"zip":254,"country":47,"countryCode":48,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Hôpital Lyon Sud","Lyon","69495",{"type":50,"coordinates":256},[257,258],4.84789,45.74906,{"lat":258,"lon":257},[261],{"name":262,"role":37,"phone":263,"phoneExt":26,"email":264},"Caroline PELLETIER, Dr","04 72 11 01 57","caroline.pelletier02@chu-lyon.fr",{"facility":266,"status":44,"city":253,"state":26,"zip":267,"country":47,"countryCode":48,"cosmosGeoPoint":268,"geoPoint":270,"contacts":271},"Hôpital Saint Joseph Saint Luc","69635",{"type":50,"coordinates":269},[257,258],{"lat":258,"lon":257},[272],{"name":273,"role":37,"phone":274,"phoneExt":26,"email":275},"Cécile CHAUVET, Dr","04 78 61 85 74","cchauvet@saintjosephsaintluc.fr",{"facility":277,"status":44,"city":278,"state":26,"zip":279,"country":47,"countryCode":48,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Institut Phocéen de Néphrologie - Clinique Bouchard","Marseille","13006",{"type":50,"coordinates":281},[282,283],5.38107,43.29695,{"lat":283,"lon":282},[286],{"name":287,"role":37,"phone":288,"phoneExt":26,"email":26},"Stanislas Bataille, Dr","04 91 15 94 10",{"facility":290,"status":62,"city":278,"state":26,"zip":291,"country":47,"countryCode":48,"cosmosGeoPoint":292,"geoPoint":294,"contacts":295},"Hôpital de la Conception, AP-HM","13385",{"type":50,"coordinates":293},[282,283],{"lat":283,"lon":282},[296],{"name":297,"role":37,"phone":298,"phoneExt":26,"email":299},"Maxence TAILLIAR, Dr","04 91 38 30 43","Maxence.Tailliar@ap-hm.fr",{"facility":301,"status":62,"city":302,"state":26,"zip":303,"country":47,"countryCode":48,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"CHU de Montpellier","Montpellier","34295",{"type":50,"coordinates":305},[306,307],3.87635,43.61093,{"lat":307,"lon":306},[310],{"name":311,"role":37,"phone":312,"phoneExt":26,"email":313},"Jean-Emmanuel Serre, Dr","04 67 33 84 76","je-serre@chu-montpellier.fr",{"facility":315,"status":62,"city":316,"state":26,"zip":317,"country":47,"countryCode":48,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"CHU de Nantes","Nantes","44093",{"type":50,"coordinates":319},[320,321],-1.55336,47.21725,{"lat":321,"lon":320},[324],{"name":325,"role":37,"phone":326,"phoneExt":26,"email":327},"Agnès CHAPELET DEBOUT, Dr","02 40 08 74 08","agnes.chapelet@chu-nantes.fr",{"facility":329,"status":44,"city":330,"state":26,"zip":331,"country":47,"countryCode":48,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"CH de Niort","Niort","79000",{"type":50,"coordinates":333},[334,335],-0.45877,46.32313,{"lat":335,"lon":334},[338],{"name":339,"role":37,"phone":340,"phoneExt":26,"email":341},"Eric Moumas, Dr","05 49 78 33 32","eric.moumas@ch-niort.fr",{"facility":343,"status":62,"city":344,"state":26,"zip":345,"country":47,"countryCode":48,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"CHU de Reims","Reims","51092",{"type":50,"coordinates":347},[348,349],4.02853,49.26526,{"lat":349,"lon":348},[352],{"name":353,"role":37,"phone":26,"phoneExt":26,"email":354},"Alain WINCKEL, Dr","awynckel@chu-reims.fr",{"facility":356,"status":62,"city":357,"state":26,"zip":358,"country":47,"countryCode":48,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"CHU de Toulouse","Toulouse","31059",{"type":50,"coordinates":360},[361,362],1.44367,43.60426,{"lat":362,"lon":361},[365],{"name":366,"role":37,"phone":367,"phoneExt":26,"email":368},"Olivier Cointault, Dr","05 61 32 25 84","cointault.o@chu-toulouse.fr",{"facility":370,"status":44,"city":357,"state":26,"zip":371,"country":47,"countryCode":48,"cosmosGeoPoint":372,"geoPoint":374,"contacts":375},"Clinique Saint Exupéry","31400",{"type":50,"coordinates":373},[361,362],{"lat":362,"lon":361},[376],{"name":377,"role":37,"phone":378,"phoneExt":26,"email":379},"Damien GUINAULT","05 61 17 32 14","damien.guinault@clinique-saint-exupery.com",{"facility":381,"status":62,"city":382,"state":26,"zip":383,"country":47,"countryCode":48,"cosmosGeoPoint":384,"geoPoint":388,"contacts":389},"CH de Valenciennes","Valenciennes","59300",{"type":50,"coordinates":385},[386,387],3.52506,50.35909,{"lat":387,"lon":386},[390],{"name":391,"role":37,"phone":392,"phoneExt":26,"email":393},"Cyrille VANDENBUSSCHE, Dr","03 27 14 30 89","vandenbussche-c@ch-valenciennes.fr",{"facility":395,"status":44,"city":396,"state":26,"zip":397,"country":47,"countryCode":48,"cosmosGeoPoint":398,"geoPoint":402,"contacts":403},"CHRU de Nancy Brabois","Vandœuvre-lès-Nancy","54500",{"type":50,"coordinates":399},[400,401],6.17114,48.66115,{"lat":401,"lon":400},[404],{"name":405,"role":37,"phone":406,"phoneExt":26,"email":407},"Asma Alla, Dr","03 83 15 31 64","a.alla@chru-nancy.fr",{"facility":409,"status":44,"city":410,"state":26,"zip":411,"country":47,"countryCode":48,"cosmosGeoPoint":412,"geoPoint":416,"contacts":417},"Centre Hospitalier Bretagne Atlantique","Vannes","56017",{"type":50,"coordinates":413},[414,415],-2.76205,47.65688,{"lat":415,"lon":414},[418],{"name":419,"role":37,"phone":26,"phoneExt":26,"email":420},"Hugoline BOULAY, Dr","hugoline.boulaycorson@ch-bretagne-atlantique.fr",{"facility":422,"status":44,"city":423,"state":26,"zip":424,"country":47,"countryCode":48,"cosmosGeoPoint":425,"geoPoint":429,"contacts":430},"CH de Vichy","Vichy","03200",{"type":50,"coordinates":426},[427,428],3.42577,46.12709,{"lat":428,"lon":427},[431],{"name":432,"role":37,"phone":433,"phoneExt":26,"email":434},"Julie Albaret, Dr","04 70 97 33 56","julie.albaret@ch-vichy.fr",{"type":436,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[438],{"name":439,"class":440},"Direction Générale de l'Offre de Soins","OTHER_GOV","100412703","rheopheresis-as-adjuvant-treatment-of-calciphylaxis-100412703",false,"NCT04654000","Rheopheresis as Adjuvant Treatment of Calciphylaxis","Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial","RHEO-CAL","Inclusion Criteria:\n\n* Calciphylaxis with at least one ulcerated or necrotizing lesion\n* End stage renal disease requiring hemodialysis\n* Weight superior to 30kg\n* Subject affiliated to or beneficiary of a social security system\n* Subject having signed written informed consent\n\nA patient with progressing calciphylaxis to ulcerate or necrosis despite conventional treatment may also be included.\n\nExclusion Criteria:\n\n* KARNOFSKY Performance Status Scale inferior to 30%\n* Life expectancy (independently of calciphylaxis) estimated \\\u003C 6 months according to a referring physician expert in hemodialysis\n* Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy)\n* Common variable immunodeficiency\n* Albumin allergy\n* Contra-indication to stop anti-vitamin K treatment\n* Severe cognitive or psychiatric disorders, patients unable to give an informed consent or unwilling to participate in the study\n* Pregnancy or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations.","ALL","18 Years",{"count":452,"type":453},138,"ESTIMATED","INTERVENTIONAL",[456],"NA","The investigators propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.",[459,460,461],"Metabolic Disorder","End Stage Renal Disease","Rare Diseases",[463,464,465,466],"Calciphylaxis","Rheopheresis","Hemodialysis","Chronic kidney disease","2026-02-09",{"date":469,"type":470},"2026-02-12","ACTUAL",{"date":472,"type":470},"2023-03-07",{"date":474,"type":453},"2027-05",{"name":5,"class":6},29]