[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100201063":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":407,"collaborators":10,"id":410,"slug":411,"hasResults":412,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":10,"eligibilityCriteria":415,"healthyVolunteers":416,"sex":417,"minAge":418,"maxAge":419,"enrollmentInfo":420,"targetDuration":423,"studyType":424,"phases":10,"briefSummary":425,"conditions":426,"keywords":431,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":445},{"fullName":5,"class":6},"Heidelberg University","OTHER",[8,12,17,21],{"label":9,"type":10,"description":11,"interventionNames":10},"Control",null,"'Biopsy sampling': Peritoneal biopsies without kidney disease, i.e. diseases not related to the kidney and not affecting the peritoneum. This group is accomplished.",{"label":13,"type":10,"description":14,"interventionNames":15},"chronic kidney disease","Samples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion)",[16],"Procedure: biopsy sampling",{"label":18,"type":10,"description":19,"interventionNames":20},"Peritoneal dialysis","Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.",[16],{"label":22,"type":10,"description":23,"interventionNames":24},"Post PD and with functioning graft","Samples will also be collected and analysed from patients with renal transplantation after PD at time of and tenckhoff catheter removal several weeks after Tx or other intercurrent abdominal surgery.",[16],[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"PROCEDURE","biopsy sampling","Two parietal peritoneal samples, each 1 cm² x 0.3 cm in depth and three omental tissue samples, each 1 cm² in size will be obtained.\n\nBiopsy sampling will be performed in all groups. This is an observational not an interventional trial.",[18,22,13],[32],{"name":33,"affiliation":34,"role":35},"Claus P Schmitt, MD","University of Heidelberg, Center for Pediatric and Adolescent Medicine","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Claus P Schmitt, Prof","CONTACT","+49 6221 56","39313","claus.peter.schmitt@med.uni-heidelberg.de",[44,58,75,85,102,119,135,152,166,183,191,205,219,236,250,266,277,291,300,317,328,344,361,372,383,398],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":10},"University of Alabama at Birmingham","ACTIVE_NOT_RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-86.80249,33.52066,{"lat":56,"lon":55},{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":50,"countryCode":51,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Children's Mercy Hospital","RECRUITING","Kansas City","Missouri","64108",{"type":53,"coordinates":65},[66,67],-94.57857,39.09973,{"lat":67,"lon":66},[70,74],{"name":71,"role":39,"phone":72,"phoneExt":10,"email":73},"Bradley A. Warady, MD","+1 8162343010","bwarady@cmh.edu",{"name":71,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":76,"status":46,"city":77,"state":78,"zip":79,"country":50,"countryCode":51,"cosmosGeoPoint":80,"geoPoint":84,"contacts":10},"The Children´s Hospital of Philadelphia","Narberth","Pennsylvania","19104",{"type":53,"coordinates":81},[82,83],-75.26046,40.00845,{"lat":83,"lon":82},{"facility":86,"status":60,"city":87,"state":10,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Department of Pediatrics, Medical University Vienna","Vienna","1090","Austria","AT",{"type":53,"coordinates":92},[93,94],16.37208,48.20849,{"lat":94,"lon":93},[97,101],{"name":98,"role":39,"phone":99,"phoneExt":10,"email":100},"Klaus Arbeiter, MD","+43 1404003257","klaus.arbeiter@meduniwien.ac.at",{"name":98,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":103,"status":60,"city":104,"state":10,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"UZ Ghent","Ghent","9890","Belgium","BE",{"type":53,"coordinates":109},[110,111],3.71667,51.05,{"lat":111,"lon":110},[114,118],{"name":115,"role":39,"phone":116,"phoneExt":10,"email":117},"Johan Van de Walle, MD","+32 93322483","Johan.VandeWalle@uzgent.be",{"name":115,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":120,"status":60,"city":121,"state":10,"zip":122,"country":123,"countryCode":10,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"University Children's Hospital","Prague","15006","Czechia",{"type":53,"coordinates":125},[126,127],14.42076,50.08804,{"lat":127,"lon":126},[130,134],{"name":131,"role":39,"phone":132,"phoneExt":10,"email":133},"Karel Vondrak, MD","+42 0224432078","8080@seznam.cz",{"name":131,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":136,"status":60,"city":137,"state":10,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant","Lyon","69677","France","FR",{"type":53,"coordinates":142},[143,144],4.84789,45.74906,{"lat":144,"lon":143},[147,151],{"name":148,"role":39,"phone":149,"phoneExt":10,"email":150},"Bruno Ranchin, MD","+33 427856129","bruno.ranchin@chu-lyon.fr",{"name":148,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":120,"status":60,"city":153,"state":10,"zip":154,"country":139,"countryCode":140,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Strasbourg","67098",{"type":53,"coordinates":156},[157,158],7.74553,48.58392,{"lat":158,"lon":157},[161,165],{"name":162,"role":39,"phone":163,"phoneExt":10,"email":164},"Ariane Zaloszyc, MD","+333388127742","ariane.zaloszyc@chru-strasbourg.fr",{"name":162,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":167,"status":60,"city":168,"state":169,"zip":170,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Department of Medicine I (Nephrology), University of Heidelberg","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":53,"coordinates":174},[175,176],8.69079,49.40768,{"lat":176,"lon":175},[179],{"name":180,"role":39,"phone":181,"phoneExt":10,"email":182},"Katrin Klein, MD","+49 62215639776","katrin.klein@med.uni-heidelberg.de",{"facility":120,"status":46,"city":184,"state":10,"zip":185,"country":171,"countryCode":172,"cosmosGeoPoint":186,"geoPoint":190,"contacts":10},"Berlin","10117",{"type":53,"coordinates":187},[188,189],13.41053,52.52437,{"lat":189,"lon":188},{"facility":120,"status":60,"city":192,"state":10,"zip":193,"country":171,"countryCode":172,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Cologne","50931",{"type":53,"coordinates":195},[196,197],6.95,50.93333,{"lat":197,"lon":196},[200,204],{"name":201,"role":39,"phone":202,"phoneExt":10,"email":203},"Christina Taylan, MD","+49 2214784391","christina.taylan@uk-koeln.de",{"name":201,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":120,"status":60,"city":206,"state":10,"zip":207,"country":171,"countryCode":172,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Essen","45122",{"type":53,"coordinates":209},[210,211],7.01228,51.45657,{"lat":211,"lon":210},[214,218],{"name":215,"role":39,"phone":216,"phoneExt":10,"email":217},"Rainer Büscher, MD","+49 201 723-2738","Rainer.Buescher@uk-essen.de",{"name":215,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":220,"status":60,"city":221,"state":10,"zip":222,"country":171,"countryCode":172,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"UKE, University Children´s Hospital","Hamburg","20251",{"type":53,"coordinates":224},[225,226],9.99302,53.55073,{"lat":226,"lon":225},[229,233],{"name":230,"role":39,"phone":231,"phoneExt":10,"email":232},"Jun Oh, MD","+49 40 7410 0","j.oh@uke.de",{"name":234,"role":235,"phone":10,"phoneExt":10,"email":10},"Christian Brix, MD","SUB_INVESTIGATOR",{"facility":237,"status":60,"city":238,"state":10,"zip":239,"country":171,"countryCode":172,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg","Marburg","35043",{"type":53,"coordinates":241},[242,243],8.77069,50.80904,{"lat":243,"lon":242},[246],{"name":247,"role":39,"phone":248,"phoneExt":10,"email":249},"Günter Klaus, Prof","+49 64215862254","Guenter.Klaus@kfh-dialyse.de",{"facility":120,"status":60,"city":251,"state":10,"zip":252,"country":253,"countryCode":254,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Budapest","1083","Hungary","HU",{"type":53,"coordinates":256},[257,258],19.04045,47.49835,{"lat":258,"lon":257},[261,265],{"name":262,"role":39,"phone":263,"phoneExt":10,"email":264},"Peter Sallay, MD","+36 13343186","sallay.peter@med.semmelweis-univ.hu",{"name":262,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":267,"status":46,"city":268,"state":10,"zip":269,"country":270,"countryCode":271,"cosmosGeoPoint":272,"geoPoint":276,"contacts":10},"University Children'Hospital","Genova","16147","Italy","IT",{"type":53,"coordinates":273},[274,275],11.87211,45.21604,{"lat":275,"lon":274},{"facility":120,"status":60,"city":278,"state":10,"zip":279,"country":270,"countryCode":271,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Milan","20122",{"type":53,"coordinates":281},[282,283],12.59836,42.78235,{"lat":283,"lon":282},[286,290],{"name":287,"role":39,"phone":288,"phoneExt":10,"email":289},"Sara Testa, MD","+39 0257992471","saratesta@tiscali.it",{"name":287,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":292,"status":46,"city":293,"state":10,"zip":294,"country":270,"countryCode":271,"cosmosGeoPoint":295,"geoPoint":299,"contacts":10},"Pediatric Nephrology, Dialysis and Transplant Unit","Padova","35128",{"type":53,"coordinates":296},[297,298],11.14261,44.38225,{"lat":298,"lon":297},{"facility":301,"status":60,"city":302,"state":10,"zip":303,"country":304,"countryCode":305,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"University children's Hospital","Vilnius","08406","Lithuania","LT",{"type":53,"coordinates":307},[308,309],25.2798,54.68916,{"lat":309,"lon":308},[312,316],{"name":313,"role":39,"phone":314,"phoneExt":10,"email":315},"Rimante Cerkauskiene, MD","+37 052720427","rimantec@yahoo.com",{"name":313,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":318,"status":46,"city":319,"state":10,"zip":320,"country":321,"countryCode":322,"cosmosGeoPoint":323,"geoPoint":327,"contacts":10},"Paediatric CAPD unit, Kuala Lumpur Hospital","Kuala Lumpur","50586","Malaysia","MY",{"type":53,"coordinates":324},[325,326],101.68653,3.1412,{"lat":326,"lon":325},{"facility":329,"status":60,"city":330,"state":10,"zip":331,"country":332,"countryCode":333,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"Krakow, Jagiellonian University Medical College","Krakow","30663","Poland","PL",{"type":53,"coordinates":335},[336,337],19.93658,50.06143,{"lat":337,"lon":336},[340],{"name":341,"role":39,"phone":342,"phoneExt":10,"email":343},"Dorota Drozdz, MD","+48 12 658 11 59","dadrozdz@cm-uj.krakow.pl",{"facility":345,"status":60,"city":346,"state":10,"zip":347,"country":348,"countryCode":349,"cosmosGeoPoint":350,"geoPoint":354,"contacts":355},"Hospital Universitario Materno-Infantil Vall d' Hebron","Barcelona","08035","Spain","ES",{"type":53,"coordinates":351},[352,353],2.15899,41.38879,{"lat":353,"lon":352},[356,360],{"name":357,"role":39,"phone":358,"phoneExt":10,"email":359},"Gema Ariceta, MD","+34 934893082","gariceta@vhebron.net",{"name":357,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":362,"status":46,"city":363,"state":10,"zip":364,"country":365,"countryCode":366,"cosmosGeoPoint":367,"geoPoint":371,"contacts":10},"Karolinska University Hospital","Stockholm","17176","Sweden","SE",{"type":53,"coordinates":368},[369,370],18.06871,59.32938,{"lat":370,"lon":369},{"facility":373,"status":46,"city":374,"state":10,"zip":375,"country":376,"countryCode":377,"cosmosGeoPoint":378,"geoPoint":382,"contacts":10},"Children's Hospital, Inselspital, Bern University Hospital and University of Bern","Bern","3010","Switzerland","CH",{"type":53,"coordinates":379},[380,381],7.44744,46.94809,{"lat":381,"lon":380},{"facility":120,"status":60,"city":384,"state":10,"zip":385,"country":386,"countryCode":10,"cosmosGeoPoint":387,"geoPoint":391,"contacts":392},"Adana","01330","Turkey (Türkiye)",{"type":53,"coordinates":388},[389,390],35.32531,36.98615,{"lat":390,"lon":389},[393,397],{"name":394,"role":39,"phone":395,"phoneExt":10,"email":396},"Aysun K Bayazit, MD","+90 3223386935","ayskar@cu.edu.tr",{"name":394,"role":35,"phone":10,"phoneExt":10,"email":10},{"facility":399,"status":46,"city":400,"state":10,"zip":401,"country":386,"countryCode":10,"cosmosGeoPoint":402,"geoPoint":406,"contacts":10},"Cerrahpasa School of Medicine","Istanbul","34303",{"type":53,"coordinates":403},[404,405],28.94966,41.01384,{"lat":405,"lon":404},{"type":35,"investigatorFullName":408,"investigatorTitle":409,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Claus Peter Schmitt","MD","100201063","international-pediatric-peritoneal-biobank-100201063",false,"NCT01893710","International (Pediatric) Peritoneal Biobank","Inclusion Criteria\n\n* Age 0 to 90 years\n* CKD 5D, peritoneal dialysis and\n* Patients with normal renal function and elective abdominal surgery due to limited abdominal pathology (such as hernia repair, gallstones….)\n* Patients post PD and post Tx\n* Oral and written consent\n* Ability to consent of the adult patient and of the parents and legal guardian of patients not yet of legal age, respectively\n\nExclusion Criteria:\n\n* Abdominal adhesions, malformation and inflammation beyond PD induced changes\n* Patients with disseminated tumour disease\n* Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk\n* Pregnancy\n* Preterm babies (below 37 weeks of gestational age)\n* Serum hemoglobin \\\u003C 10 g\u002Fdl in newborns and \\\u003C 8 g\u002Fdl in children and adults",true,"ALL","1 Day","90 Years",{"count":421,"type":422},500,"ESTIMATED","2 Years","OBSERVATIONAL","Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent.\n\nAn international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime.\n\n3\u002F2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.",[427,428,429,430],"Kidney Failure, Chronic","Peritoneal Dialysis Complication","Transplantation","Healthy",[432,433,434,13,435],"peritoneal dialysis","parietal peritoneum","omentum","vasculopathy","2026-04-29",{"date":438,"type":439},"2026-04-30","ACTUAL",{"date":441,"type":439},"2011-02-01",{"date":443,"type":422},"2028-12-31",{"name":5,"class":6},26]