[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100362076":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":43,"locations":49,"responsibleParty":505,"collaborators":47,"id":507,"slug":508,"hasResults":509,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":509,"sex":515,"minAge":516,"maxAge":47,"enrollmentInfo":517,"targetDuration":47,"studyType":520,"phases":521,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":67,"whyStopped":47,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":538},{"fullName":5,"class":6},"Iperboreal Pharma Srl","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"XyloCore peritoneal dialysis solution","EXPERIMENTAL","Patients will receive 1, 2 or 3 daily (short-dwell) exchanges with XyloCore of an osmotic strength comparable to their pre-randomization prescription of glucose peritoneal dialysis solution (XyloCore Low, Medium and High Strenght have an osmotic strength comparable to Physioneal, Fixioneal or Dianeal 1.36%, 2.27%, 3.86% glucose, respectively, and Balance, Bicavera, Bicanova or Equibalance with 1.5%, 2.5%, 4.25% glucose, respectively). All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.",[13],"Drug: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght",{"label":15,"type":16,"description":17,"interventionNames":18},"Glucose peritoneal dialysis solution","ACTIVE_COMPARATOR","Patients randomized to glucose solution will continue the 1, 2 or 3 daily (short-dwell) exchanges of Physioneal 40 or 35, Fixioneal 40 or 35 or Dianeal (1.36%, 2.27%, 3.86% glucose), Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.5%, 4.25% glucose) with the same osmotic strength of their pre-randomization prescription. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.",[19],"Drug: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght","XyloCore Low Strenght: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore Medium Strenght: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore High Strenght: 2.0% Xylitol, 1.5% Glucose, and 0.02% L-carnitine",[9],[27],"XyloCore 0.7 or 1.5 or 2.0",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution","Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium have 1.36%, 2.27% or 3.86% glucose; Balance, Bicavera, Bicanova or Equibalance have 1.25%, 2.3%, 4.5% glucose.",[15],[33],"Physioneal 40 or 35, Fixioneal 40 or 35, Dianeal, Balance, Bicavera, Bicanova, Equibalance",[35,39],{"name":36,"affiliation":37,"role":38},"Arduino Arduini, MD","Iperboreal Pharma","STUDY_DIRECTOR",{"name":40,"affiliation":41,"role":42},"Werner Kleophas, MD","DaVita Deutschland AG","STUDY_CHAIR",[44],{"name":36,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","+39.333.6409595",null,"a.arduini@iperboreal.com",[50,65,77,88,101,114,125,136,147,159,170,181,192,200,211,222,230,241,252,263,274,285,296,307,320,331,342,353,364,372,380,391,404,415,428,439,450,461,472,483,494],{"facility":51,"status":52,"city":53,"state":47,"zip":47,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Aalborg University","NOT_YET_RECRUITING","Aalborg","Denmark","DK",{"type":57,"coordinates":58},"Point",[59,60],9.9187,57.048,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":47,"phoneExt":47,"email":47},"Hanna Sofia Svensson, MD",{"facility":66,"status":67,"city":68,"state":47,"zip":47,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Aarhus University Hospital","RECRUITING","Aarhus",{"type":57,"coordinates":70},[71,72],10.21076,56.15674,{"lat":72,"lon":71},[75],{"name":76,"role":45,"phone":47,"phoneExt":47,"email":47},"Johan Povlsen, MD",{"facility":78,"status":67,"city":79,"state":47,"zip":47,"country":54,"countryCode":55,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Zealand University Hospital","Roskilde",{"type":57,"coordinates":81},[82,83],12.08035,55.64152,{"lat":83,"lon":82},[86],{"name":87,"role":45,"phone":47,"phoneExt":47,"email":47},"Kirstine Møller Gliese, MD",{"facility":89,"status":67,"city":90,"state":47,"zip":47,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Dialysis Center DaVita","Düsseldorf","Germany","DE",{"type":57,"coordinates":94},[95,96],6.77927,51.22319,{"lat":96,"lon":95},[99],{"name":100,"role":45,"phone":47,"phoneExt":47,"email":47},"Thilo Krueger, MD",{"facility":102,"status":67,"city":103,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Ospedale Madonna del Soccorso","Ascoli Piceno","Italy","IT",{"type":57,"coordinates":107},[108,109],13.57395,42.85351,{"lat":109,"lon":108},[112],{"name":113,"role":45,"phone":47,"phoneExt":47,"email":47},"Matthias Zeiler, MD",{"facility":115,"status":52,"city":116,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Ospedale Santa Maria Annunziata","Bagno a Ripoli",{"type":57,"coordinates":118},[119,120],11.32252,43.75115,{"lat":120,"lon":119},[123],{"name":124,"role":45,"phone":47,"phoneExt":47,"email":47},"Rossella Cannavò, MD",{"facility":126,"status":67,"city":127,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Azienda Universitaria Ospedaliera di Bari","Bari",{"type":57,"coordinates":129},[130,131],16.86982,41.12066,{"lat":131,"lon":130},[134],{"name":135,"role":45,"phone":47,"phoneExt":47,"email":47},"Loreto Gesualdo, MD",{"facility":137,"status":52,"city":138,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"ASST Spedali Civili di Brescia","Brescia",{"type":57,"coordinates":140},[141,142],10.21472,45.53558,{"lat":142,"lon":141},[145],{"name":146,"role":45,"phone":47,"phoneExt":47,"email":47},"Federico Alberici, MD",{"facility":148,"status":67,"city":149,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Ospedale SS. Annunziata","Chieti",{"type":57,"coordinates":151},[152,153],14.16494,42.34827,{"lat":153,"lon":152},[156],{"name":157,"role":45,"phone":47,"phoneExt":47,"email":158},"Mario Bonomini, MD","mario.bonomini@unich.it",{"facility":160,"status":52,"city":161,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"IRCCS Policlinico San Martino","Genova",{"type":57,"coordinates":163},[164,165],11.87211,45.21604,{"lat":165,"lon":164},[168],{"name":169,"role":45,"phone":47,"phoneExt":47,"email":47},"Francesca Cappadona, MD",{"facility":171,"status":67,"city":172,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Ospedale Civile San Salvatore","L’Aquila",{"type":57,"coordinates":174},[175,176],13.39954,42.35055,{"lat":176,"lon":175},[179],{"name":180,"role":45,"phone":47,"phoneExt":47,"email":47},"Luca Piscitani, MD",{"facility":182,"status":67,"city":183,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco","Milan",{"type":57,"coordinates":185},[186,187],12.59836,42.78235,{"lat":187,"lon":186},[190],{"name":191,"role":45,"phone":47,"phoneExt":47,"email":47},"Maurizio Gallieni, MD",{"facility":193,"status":52,"city":183,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico",{"type":57,"coordinates":195},[186,187],{"lat":187,"lon":186},[198],{"name":199,"role":45,"phone":47,"phoneExt":47,"email":47},"Luca Nardelli, MD",{"facility":201,"status":67,"city":202,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Azienda Ospedaliera Universitaria di Modena","Modena",{"type":57,"coordinates":204},[205,206],10.92539,44.64783,{"lat":206,"lon":205},[209],{"name":210,"role":45,"phone":47,"phoneExt":47,"email":47},"Gabriele Donati, MD",{"facility":212,"status":67,"city":213,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"AOU Università degli studi della Campania","Naples",{"type":57,"coordinates":215},[216,217],14.26811,40.85216,{"lat":217,"lon":216},[220],{"name":221,"role":45,"phone":47,"phoneExt":47,"email":47},"Francesco Trepiccione, MD",{"facility":223,"status":67,"city":213,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":224,"geoPoint":226,"contacts":227},"Università della Campania L.Vanvitelli",{"type":57,"coordinates":225},[216,217],{"lat":217,"lon":216},[228],{"name":229,"role":45,"phone":47,"phoneExt":47,"email":47},"Silvio Borrelli, MD",{"facility":231,"status":52,"city":232,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Azienda Ospedaliera di Padova","Padova",{"type":57,"coordinates":234},[235,236],11.14261,44.38225,{"lat":236,"lon":235},[239],{"name":240,"role":45,"phone":47,"phoneExt":47,"email":47},"Anna Bass, MD",{"facility":242,"status":67,"city":243,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Ospedale AUSL \"Guglielmo da Saliceto\"","Piacenza",{"type":57,"coordinates":245},[246,247],9.69342,45.05242,{"lat":247,"lon":246},[250],{"name":251,"role":45,"phone":47,"phoneExt":47,"email":47},"Roberto Scarpioni, MD",{"facility":253,"status":52,"city":254,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Ospedale S.Eugenio","Roma",{"type":57,"coordinates":256},[257,258],11.10642,44.99364,{"lat":258,"lon":257},[261],{"name":262,"role":45,"phone":47,"phoneExt":47,"email":47},"Roberto Palumbo, MD",{"facility":264,"status":67,"city":265,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Ospedale C. e G. Mazzoni","San Benedetto del Tronto",{"type":57,"coordinates":267},[268,269],13.87676,42.9568,{"lat":269,"lon":268},[272],{"name":273,"role":45,"phone":47,"phoneExt":47,"email":47},"Matthias Zailer, MD",{"facility":275,"status":67,"city":276,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Azienda Ospedaliera Terni","Terni",{"type":57,"coordinates":278},[279,280],12.64329,42.56335,{"lat":280,"lon":279},[283],{"name":284,"role":45,"phone":47,"phoneExt":47,"email":47},"Luigi Vecchi, MD",{"facility":286,"status":67,"city":287,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Ospedale San Giovanni Bosco","Torino",{"type":57,"coordinates":289},[290,291],11.99138,44.88856,{"lat":291,"lon":290},[294],{"name":295,"role":45,"phone":47,"phoneExt":47,"email":47},"Dario Roccatello, MD",{"facility":297,"status":67,"city":298,"state":47,"zip":47,"country":104,"countryCode":105,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Azienda Ospedaliera Universitaria Integrata di Verona","Verona",{"type":57,"coordinates":300},[301,302],10.9938,45.43854,{"lat":302,"lon":301},[305],{"name":306,"role":45,"phone":47,"phoneExt":47,"email":47},"Giovanni Gambaro, MD",{"facility":308,"status":67,"city":309,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"University Hospital A Coruña Fundación Profesor Novoa Santos","A Coruña","Spain","ES",{"type":57,"coordinates":313},[314,315],-8.396,43.37135,{"lat":315,"lon":314},[318],{"name":319,"role":45,"phone":47,"phoneExt":47,"email":47},"Miguel Perez Fontan, MD",{"facility":321,"status":67,"city":322,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"Hospital U. Germans Trias i Pujol","Badalona",{"type":57,"coordinates":324},[325,326],2.24741,41.45004,{"lat":326,"lon":325},[329],{"name":330,"role":45,"phone":47,"phoneExt":47,"email":47},"Marie Troya Saborido, MD",{"facility":332,"status":67,"city":333,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"Fundaciòn Puigvert","Barcelona",{"type":57,"coordinates":335},[336,337],2.15899,41.38879,{"lat":337,"lon":336},[340],{"name":341,"role":45,"phone":47,"phoneExt":47,"email":47},"Maria Alba Herreros, MD",{"facility":343,"status":67,"city":344,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Hospital Universitario Josep Trueta","Girona",{"type":57,"coordinates":346},[347,348],2.82493,41.98311,{"lat":348,"lon":347},[351],{"name":352,"role":45,"phone":47,"phoneExt":47,"email":47},"Claudia Castillo Devia",{"facility":354,"status":67,"city":355,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Fundacion Jimenez Diaz","Madrid",{"type":57,"coordinates":357},[358,359],-3.70256,40.4165,{"lat":359,"lon":358},[362],{"name":363,"role":45,"phone":47,"phoneExt":47,"email":47},"Catalina Cleary, MD",{"facility":365,"status":52,"city":355,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":366,"geoPoint":368,"contacts":369},"Hospital Ramón y Cajal",{"type":57,"coordinates":367},[358,359],{"lat":359,"lon":358},[370],{"name":371,"role":45,"phone":47,"phoneExt":47,"email":47},"Haridian Sosa Barrios, MD",{"facility":373,"status":67,"city":355,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":374,"geoPoint":376,"contacts":377},"Hospital Universitario La Paz",{"type":57,"coordinates":375},[358,359],{"lat":359,"lon":358},[378],{"name":379,"role":45,"phone":47,"phoneExt":47,"email":47},"Maria Bajo, MD",{"facility":381,"status":67,"city":382,"state":47,"zip":47,"country":310,"countryCode":311,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"Hospital Universitario Central De Asturias","Oviedo",{"type":57,"coordinates":384},[385,386],-5.84476,43.36029,{"lat":386,"lon":385},[389],{"name":390,"role":45,"phone":47,"phoneExt":47,"email":47},"Marie Rodriguez Suarez, MD",{"facility":392,"status":67,"city":393,"state":47,"zip":47,"country":394,"countryCode":395,"cosmosGeoPoint":396,"geoPoint":400,"contacts":401},"Halland County Hospital of Halmstad","Halmstad","Sweden","SE",{"type":57,"coordinates":397},[398,399],12.85676,56.67446,{"lat":399,"lon":398},[402],{"name":403,"role":45,"phone":47,"phoneExt":47,"email":47},"Karl Bjurström, MD",{"facility":405,"status":67,"city":406,"state":47,"zip":47,"country":394,"countryCode":395,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"Karolinska University Hospital","Stockholm",{"type":57,"coordinates":408},[409,410],18.06871,59.32938,{"lat":410,"lon":409},[413],{"name":414,"role":45,"phone":47,"phoneExt":47,"email":47},"Olof Heimbürger, MD",{"facility":416,"status":67,"city":417,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":420,"geoPoint":424,"contacts":425},"Heartlands Hospital","Birmingham","United Kingdom","UK",{"type":57,"coordinates":421},[422,423],-1.89983,52.48142,{"lat":423,"lon":422},[426],{"name":427,"role":45,"phone":47,"phoneExt":47,"email":47},"Jyoti Baharani, MD",{"facility":429,"status":67,"city":430,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"St Luke's Hospital","Bradford",{"type":57,"coordinates":432},[433,434],-1.75206,53.79391,{"lat":434,"lon":433},[437],{"name":438,"role":45,"phone":47,"phoneExt":47,"email":47},"Ahsan Syed, MD",{"facility":440,"status":67,"city":441,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":442,"geoPoint":446,"contacts":447},"University Hospitals Sussex","Brighton",{"type":57,"coordinates":443},[444,445],-0.13947,50.82838,{"lat":445,"lon":444},[448],{"name":449,"role":45,"phone":47,"phoneExt":47,"email":47},"Sarah Lawman, MD",{"facility":451,"status":67,"city":452,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":453,"geoPoint":457,"contacts":458},"Kent and Canterbury Hospital","Canterbury",{"type":57,"coordinates":454},[455,456],1.07992,51.27904,{"lat":456,"lon":455},[459],{"name":460,"role":45,"phone":47,"phoneExt":47,"email":47},"Nilesh Kumar Shah, MD",{"facility":462,"status":67,"city":463,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":464,"geoPoint":468,"contacts":469},"Hammersmith Hospital","London",{"type":57,"coordinates":465},[466,467],-0.12574,51.50853,{"lat":467,"lon":466},[470],{"name":471,"role":45,"phone":47,"phoneExt":47,"email":47},"Richard Corbett, MD",{"facility":473,"status":67,"city":474,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":475,"geoPoint":479,"contacts":480},"Churchill Hospital","Oxford",{"type":57,"coordinates":476},[477,478],-1.25596,51.75222,{"lat":478,"lon":477},[481],{"name":482,"role":45,"phone":47,"phoneExt":47,"email":47},"Udaya Udayaraj, MD",{"facility":484,"status":67,"city":485,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":486,"geoPoint":490,"contacts":491},"Sheffield Kidney Institute","Sheffield",{"type":57,"coordinates":487},[488,489],-1.4659,53.38297,{"lat":489,"lon":488},[492],{"name":493,"role":45,"phone":47,"phoneExt":47,"email":47},"Martin Wilkie, MD",{"facility":495,"status":67,"city":496,"state":47,"zip":47,"country":418,"countryCode":419,"cosmosGeoPoint":497,"geoPoint":501,"contacts":502},"University Hospitals of North Midlands","Stoke-on-Trent",{"type":57,"coordinates":498},[499,500],-2.18538,53.00415,{"lat":500,"lon":499},[503],{"name":504,"role":45,"phone":47,"phoneExt":47,"email":47},"Mark Lambie, MD",{"type":506,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100362076","phase-3-efficacy-and-safety-of-xylocore-peritoneal-dialysis-solution-100362076",false,"NCT03994471","Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.","A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis","ELIXIR","INCLUSION CRITERIA:\n\n1. Age ≥18 years\n2. Diagnosed with ESRD and treated with CAPD in the last 3 months\n3. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events\n4. Have not experienced peritonitis episodes in the last 3 months\n5. In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month\n6. In treatment with 1, 2 or 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose)\n7. Kt\u002FV urea measurement \\> 1.7 per week at Baseline Visit\n8. Followed\u002Ftreated by the participating clinical Center\u002FInvestigator in the last three months\n9. Understanding the nature of the study and providing their informed consent to participation.\n\nEXCLUSION CRITERIA:\n\n1. History of drug or alcohol abuse in the six months prior to entering the protocol\n2. In treatment with androgens\n3. Clinically significant abnormal liver function test (ɣ-GT \\> 4 times the upper normal limit)\n4. Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)\n5. Expected patient's survival shorter than the trial duration\n6. History of L-Carnitine therapy or use in the month prior to entering the protocol\n7. Have used any investigational drug in the 3 months prior to entering the protocol\n8. Female patients who are pregnant or breast-feeding.\n9. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception\n10. Patients affected by Primary Hyperoxaluria as per known medical therapy\n11. Patients with serum levels of uric acid \\> 7.2 mg\u002Fdl (male and postmenopausal women) or \\> 6.0 mg\u002Fdl (premenopausal women)\n12. Patients with a major cardiovascular event in the last 3 months\n13. Patients with advanced cardiac failure (NYHA 4)\n14. Hypersensitivity to any of the constituents of the study IMPs.\n15. Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.\n16. Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.\n17. History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant AE or interfere with study assessments during the course of the trial as determined by the clinical judgment of the investigator.","ALL","18 Years",{"count":518,"type":519},170,"ESTIMATED","INTERVENTIONAL",[522],"PHASE3","Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.",[525],"End Stage Renal Disease",[527,528],"peritoneal dialysis","ESRD","2026-03-23",{"date":531,"type":532},"2026-03-24","ACTUAL",{"date":534,"type":532},"2022-12-14",{"date":536,"type":519},"2027-04-28",{"name":5,"class":6},41]