[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412703":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":434,"collaborators":436,"id":440,"slug":26,"hasResults":441,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":441,"sex":447,"minAge":448,"maxAge":26,"enrollmentInfo":449,"targetDuration":26,"studyType":452,"phases":453,"briefSummary":455,"conditions":456,"keywords":460,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},{"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",[42,59,74,88,102,116,130,144,158,172,185,199,213,226,236,250,264,275,288,299,313,327,341,354,368,379,393,407,420],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"CHU d'Angers","NOT_YET_RECRUITING","Angers","49933","France",{"type":49,"coordinates":50},"Point",[51,52],-0.55202,47.47156,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":26,"email":58},"Anne-Sophie Garnier, Dr","02 41 35 50 63","annesophie.garnier@chu-angers.fr",{"facility":60,"status":61,"city":62,"state":26,"zip":63,"country":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"CHU d'Arras","RECRUITING","Arras","62022",{"type":49,"coordinates":65},[66,67],2.78186,50.29301,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":72,"phoneExt":26,"email":73},"Amr EKHLAS, Dr","03 21 21 14 40","amr.ekhlas@gh-artoisternois.fr",{"facility":75,"status":44,"city":76,"state":26,"zip":77,"country":47,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"CHU d'Auxerre","Auxerre","89011",{"type":49,"coordinates":79},[80,81],3.57033,47.7996,{"lat":81,"lon":80},[84],{"name":85,"role":37,"phone":86,"phoneExt":26,"email":87},"Rachid Bourouma, Dr","03 86 48 47 16","rbourouma@ch-auxerre.fr",{"facility":89,"status":61,"city":90,"state":26,"zip":91,"country":47,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"CHU de Besançon, Hôpital Jean Minjoz","Besançon","25000",{"type":49,"coordinates":93},[94,95],6.01815,47.24878,{"lat":95,"lon":94},[98],{"name":99,"role":37,"phone":100,"phoneExt":26,"email":101},"Thomas CREPIN, Dr","03 81 21 82 56","tcrepin@chu-besancon.fr",{"facility":103,"status":61,"city":104,"state":26,"zip":105,"country":47,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"CH de Béthune","Béthune","62408",{"type":49,"coordinates":107},[108,109],2.64003,50.52965,{"lat":109,"lon":108},[112],{"name":113,"role":37,"phone":114,"phoneExt":26,"email":115},"Anderson RATSIMBAZAFY, Dr","03 21 64 43 44","anderson.ratsimbazafy@ch-bethune.fr",{"facility":117,"status":61,"city":118,"state":26,"zip":119,"country":47,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"CH de Boulogne sur Mer","Boulogne-sur-Mer","62321",{"type":49,"coordinates":121},[122,123],1.61373,50.72485,{"lat":123,"lon":122},[126],{"name":127,"role":37,"phone":128,"phoneExt":26,"email":129},"Vincent Delattre, Dr","03 21 99 88 01","v.delattre@ch-boulogne.fr",{"facility":131,"status":44,"city":132,"state":26,"zip":133,"country":47,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"CHU de Bordeaux","Bourdeaux","33076",{"type":49,"coordinates":135},[136,137],5.13611,44.58582,{"lat":137,"lon":136},[140],{"name":141,"role":37,"phone":142,"phoneExt":26,"email":143},"M Yahsou Delmas, Dr","05 56 79 58 31","yahsou.delmas@chu-bordeaux.fr",{"facility":145,"status":44,"city":146,"state":26,"zip":147,"country":47,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"CHRU de Brest","Brest","29609",{"type":49,"coordinates":149},[150,151],-4.48628,48.39029,{"lat":151,"lon":150},[154],{"name":155,"role":37,"phone":156,"phoneExt":26,"email":157},"Isabelle SEGALEN, Dr","02 98 34 25 33","isabelle.segalen@chu-brest.fr",{"facility":159,"status":44,"city":160,"state":26,"zip":161,"country":47,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"CHU de Caen","Caen","14033",{"type":49,"coordinates":163},[164,165],-0.35912,49.18585,{"lat":165,"lon":164},[168],{"name":169,"role":37,"phone":170,"phoneExt":26,"email":171},"Patrick Henri, Dr","02 31 27 23 43","henri-p@chu-caen.fr",{"facility":173,"status":61,"city":174,"state":26,"zip":175,"country":47,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Hôpital Nord Michallon, CHU de Grenoble","Grenoble","38043",{"type":49,"coordinates":177},[178,179],5.71479,45.17869,{"lat":179,"lon":178},[182],{"name":183,"role":37,"phone":26,"phoneExt":26,"email":184},"Lionel ROSTAING, Pr","lrostaing@chu-grenoble.fr",{"facility":186,"status":61,"city":187,"state":26,"zip":188,"country":47,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Centre ECHO Laval","Laval","53015",{"type":49,"coordinates":190},[191,192],-0.77019,48.07247,{"lat":192,"lon":191},[195],{"name":196,"role":37,"phone":197,"phoneExt":26,"email":198},"Wael EL HAGGAN, Dr","02 43 66 39 52","welhagga@echo-sante.com",{"facility":200,"status":61,"city":201,"state":26,"zip":202,"country":47,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Centre ECHO Le Mans","Le Mans","72000",{"type":49,"coordinates":204},[205,206],0.20251,48.0021,{"lat":206,"lon":205},[209],{"name":210,"role":37,"phone":211,"phoneExt":26,"email":212},"Guillaume SERET, Dr","02 43 78 38 79","gseret@echo-sante.com",{"facility":214,"status":61,"city":215,"state":26,"zip":216,"country":47,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Hôpital Privé La Louvière","Lille","59000",{"type":49,"coordinates":218},[219,220],3.05512,50.63391,{"lat":220,"lon":219},[223],{"name":224,"role":37,"phone":225,"phoneExt":26,"email":26},"Laurence VRIGNEAUD, Dr","03 20 15 71 31",{"facility":227,"status":61,"city":215,"state":26,"zip":26,"country":47,"cosmosGeoPoint":228,"geoPoint":230,"contacts":231},"Hop Claude Huriez Chu Lille",{"type":49,"coordinates":229},[219,220],{"lat":220,"lon":219},[232],{"name":233,"role":37,"phone":234,"phoneExt":26,"email":235},"Arnaud Lionet, Dr","03 20 44 50 00","arnaud.lionet@chu-lille.fr",{"facility":237,"status":61,"city":238,"state":26,"zip":239,"country":47,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"CHR de Limoges","Limoges","87042",{"type":49,"coordinates":241},[242,243],1.24759,45.83362,{"lat":243,"lon":242},[246],{"name":247,"role":37,"phone":248,"phoneExt":26,"email":249},"Zhour El Ouafi, Dr","06 80 26 75 81","zhour.elouafi@chu-limoges.fr",{"facility":251,"status":44,"city":252,"state":26,"zip":253,"country":47,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Hôpital Lyon Sud","Lyon","69495",{"type":49,"coordinates":255},[256,257],4.84789,45.74906,{"lat":257,"lon":256},[260],{"name":261,"role":37,"phone":262,"phoneExt":26,"email":263},"Caroline PELLETIER, Dr","04 72 11 01 57","caroline.pelletier02@chu-lyon.fr",{"facility":265,"status":44,"city":252,"state":26,"zip":266,"country":47,"cosmosGeoPoint":267,"geoPoint":269,"contacts":270},"Hôpital Saint Joseph Saint Luc","69635",{"type":49,"coordinates":268},[256,257],{"lat":257,"lon":256},[271],{"name":272,"role":37,"phone":273,"phoneExt":26,"email":274},"Cécile CHAUVET, Dr","04 78 61 85 74","cchauvet@saintjosephsaintluc.fr",{"facility":276,"status":44,"city":277,"state":26,"zip":278,"country":47,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Institut Phocéen de Néphrologie - Clinique Bouchard","Marseille","13006",{"type":49,"coordinates":280},[281,282],5.38107,43.29695,{"lat":282,"lon":281},[285],{"name":286,"role":37,"phone":287,"phoneExt":26,"email":26},"Stanislas Bataille, Dr","04 91 15 94 10",{"facility":289,"status":61,"city":277,"state":26,"zip":290,"country":47,"cosmosGeoPoint":291,"geoPoint":293,"contacts":294},"Hôpital de la Conception, AP-HM","13385",{"type":49,"coordinates":292},[281,282],{"lat":282,"lon":281},[295],{"name":296,"role":37,"phone":297,"phoneExt":26,"email":298},"Maxence TAILLIAR, Dr","04 91 38 30 43","Maxence.Tailliar@ap-hm.fr",{"facility":300,"status":61,"city":301,"state":26,"zip":302,"country":47,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"CHU de Montpellier","Montpellier","34295",{"type":49,"coordinates":304},[305,306],3.87635,43.61093,{"lat":306,"lon":305},[309],{"name":310,"role":37,"phone":311,"phoneExt":26,"email":312},"Jean-Emmanuel Serre, Dr","04 67 33 84 76","je-serre@chu-montpellier.fr",{"facility":314,"status":61,"city":315,"state":26,"zip":316,"country":47,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"CHU de Nantes","Nantes","44093",{"type":49,"coordinates":318},[319,320],-1.55336,47.21725,{"lat":320,"lon":319},[323],{"name":324,"role":37,"phone":325,"phoneExt":26,"email":326},"Agnès CHAPELET DEBOUT, Dr","02 40 08 74 08","agnes.chapelet@chu-nantes.fr",{"facility":328,"status":44,"city":329,"state":26,"zip":330,"country":47,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"CH de Niort","Niort","79000",{"type":49,"coordinates":332},[333,334],-0.45877,46.32313,{"lat":334,"lon":333},[337],{"name":338,"role":37,"phone":339,"phoneExt":26,"email":340},"Eric Moumas, Dr","05 49 78 33 32","eric.moumas@ch-niort.fr",{"facility":342,"status":61,"city":343,"state":26,"zip":344,"country":47,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"CHU de Reims","Reims","51092",{"type":49,"coordinates":346},[347,348],4.02853,49.26526,{"lat":348,"lon":347},[351],{"name":352,"role":37,"phone":26,"phoneExt":26,"email":353},"Alain WINCKEL, Dr","awynckel@chu-reims.fr",{"facility":355,"status":61,"city":356,"state":26,"zip":357,"country":47,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"CHU de Toulouse","Toulouse","31059",{"type":49,"coordinates":359},[360,361],1.44367,43.60426,{"lat":361,"lon":360},[364],{"name":365,"role":37,"phone":366,"phoneExt":26,"email":367},"Olivier Cointault, Dr","05 61 32 25 84","cointault.o@chu-toulouse.fr",{"facility":369,"status":44,"city":356,"state":26,"zip":370,"country":47,"cosmosGeoPoint":371,"geoPoint":373,"contacts":374},"Clinique Saint Exupéry","31400",{"type":49,"coordinates":372},[360,361],{"lat":361,"lon":360},[375],{"name":376,"role":37,"phone":377,"phoneExt":26,"email":378},"Damien GUINAULT","05 61 17 32 14","damien.guinault@clinique-saint-exupery.com",{"facility":380,"status":61,"city":381,"state":26,"zip":382,"country":47,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"CH de Valenciennes","Valenciennes","59300",{"type":49,"coordinates":384},[385,386],3.52506,50.35909,{"lat":386,"lon":385},[389],{"name":390,"role":37,"phone":391,"phoneExt":26,"email":392},"Cyrille VANDENBUSSCHE, Dr","03 27 14 30 89","vandenbussche-c@ch-valenciennes.fr",{"facility":394,"status":44,"city":395,"state":26,"zip":396,"country":47,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"CHRU de Nancy Brabois","Vandœuvre-lès-Nancy","54500",{"type":49,"coordinates":398},[399,400],6.17114,48.66115,{"lat":400,"lon":399},[403],{"name":404,"role":37,"phone":405,"phoneExt":26,"email":406},"Asma Alla, Dr","03 83 15 31 64","a.alla@chru-nancy.fr",{"facility":408,"status":44,"city":409,"state":26,"zip":410,"country":47,"cosmosGeoPoint":411,"geoPoint":415,"contacts":416},"Centre Hospitalier Bretagne Atlantique","Vannes","56017",{"type":49,"coordinates":412},[413,414],-2.76205,47.65688,{"lat":414,"lon":413},[417],{"name":418,"role":37,"phone":26,"phoneExt":26,"email":419},"Hugoline BOULAY, Dr","hugoline.boulaycorson@ch-bretagne-atlantique.fr",{"facility":421,"status":44,"city":422,"state":26,"zip":423,"country":47,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"CH de Vichy","Vichy","03200",{"type":49,"coordinates":425},[426,427],3.42577,46.12709,{"lat":427,"lon":426},[430],{"name":431,"role":37,"phone":432,"phoneExt":26,"email":433},"Julie Albaret, Dr","04 70 97 33 56","julie.albaret@ch-vichy.fr",{"type":435,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[437],{"name":438,"class":439},"Direction Générale de l'Offre de Soins","OTHER_GOV","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":450,"type":451},138,"ESTIMATED","INTERVENTIONAL",[454],"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.",[457,458,459],"Metabolic Disorder","End Stage Renal Disease","Rare Diseases",[461,462,463,464],"Calciphylaxis","Rheopheresis","Hemodialysis","Chronic kidney disease","2026-02-09",{"date":467,"type":468},"2026-02-12","ACTUAL",{"date":470,"type":468},"2023-03-07",{"date":472,"type":451},"2027-05",{"name":5,"class":6},29]