[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558548":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":53,"collaborators":34,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":34,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":34,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SICO(single-dose icodextrin)","EXPERIMENTAL","Eligible participants used one icodextrin bag (single-dose icodextrin, SICO) on the first day. Icodextrin solution was left in the peritoneal cavity for a 8-hour dwell. After the icodextrin exchange, the solution was drained from the peritoneal cavity and the patients resumed dialysis using dextrose dialysate with three additional manual exchanges performed for the balance of the 24 hours since the icodextrin dwell was initiated. Patients were discharged and requested to return on days 7 and 14. Blood, urine and dialysate samples are collected at the time-points as required. Icodextrin and metabolites were analyzed and the pharmacokinetics profiles of single-dose icodextrin were provided.",[13],"Drug: Icodextrin",{"label":15,"type":10,"description":16,"interventionNames":17},"DICO(double-dose icodextrin)","Eligible participants used two icodextrin bags (double-dose icodextrin, DICO) on the first day. Each icodextrin solution was left in the peritoneal cavity for a 8-hour dwell. The double-dose icodextrin was administered in a sequential way. After the icodextrin exchange, the solution was drained from the peritoneal cavity and the patients resumed dialysis using dextrose dialysate with three additional manual exchanges performed for the balance of the 24 hours since the icodextrin dwell was initiated. Patients were discharged and requested to return on days 7 and 14. Blood, urine and dialysate samples are collected at the time-points as required. Icodextrin and metabolites were analyzed and the pharmacokinetics profiles of double-dose icodextrin were provided.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Icodextrin","Eligible participants were admitted to the hosptial ward and used one icodextrin bag (single-dose icodextrin) or two icodextrin bags (double-dose icodextrin) on the first day, depending on their choice. Each icodextrin solution was left in the peritoneal cavity for a 8-hour dwell. The double-dose icodextrin was administered in a sequential way. After the icodextrin exchange(s), the solution was drained from the peritoneal cavity and the patients resumed dialysis using dextrose dialysate with two or three additional manual exchanges performed for the balance of the 24 hours since the icodextrin dwell was initiated. Patients were discharged and requested to return on days 7 and 14. Blood, urine and dialysate samples are collected at the time-points as required. Icodextrin and metabolites were analyzed and the pharmacokinetics profiles of single- and double-dose icodextrin were provided.",[15,9],[25],"Extraneal®，Baxter Healthcare (Guangzhou) Co., Ltd.， Guangzhou，China",[27],{"name":28,"affiliation":5,"role":29},"Jie Dong, Professor","PRINCIPAL_INVESTIGATOR",[31,36],{"name":28,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","+86-13911841538",null,"jie.dong@bjmu.edu.cn",{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},"Zhikai Yang, Doctor","+86-13671248465","seapollar@126.com",[41],{"facility":5,"status":34,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":34},"Beijing","Beijing Municipality","100034","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},{"type":29,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Dong Jie","Professor","100558548","pharmacokinetics-of-single--and-double-dose-icodextrin-100558548",false,"NCT06552546","Pharmacokinetics of Single- and Double-dose Icodextrin","Pharmacokinetics of Single- and Double-dose Icodextrin in Patients on Peritoneal Dialysis","Inclusion Criteria:\n\n* Patients with end stage renal disease, receiving peritoneal dialysis for \\> 3 months, and clinically stable.\n* Suitable for 4 exchanges of manual peritoneal dialysis on the first study day.\n\nExclusion Criteria:\n\n* History of allergic reaction to icodextrin dialysis solution or corn starch;\n* With malignant tumor receiving radiotherapy and\u002For chemotherapy, active hepatitis or hepatic failure, active autoimmune disease, severe digestive malabsorption or an eating disorder, or HIV\u002FAIDS;\n* Acute systemic infection, peritonitis, catheter-related infection, cardiovascular disease, surgery, or trauma in the previous one month;\n* A high probability of receiving a kidney transplant or transferring to hemodialysis or drop-out due to socioeconomic causes within 1 months;\n* Receiving hybrid dialysis (peritoneal dialysis combined with hemodialysis);\n* Pregnant or lactating female;\n* Having used icodextrin within previous 30 days；\n* Peritoneal catheter dysfunction；\n* Not suitable for enrollment assessed by researchers, including those unable followed the study protocol, or enrolled in other intervention studies, or with other reasons considering not suitable for enrollment by researchers.","ALL","18 Years","79 Years",{"count":67,"type":68},16,"ESTIMATED","INTERVENTIONAL",[71],"NA","The study aims to provide the pharmacokinetics profiles of single- and double-dose icodextrin in patients on peritoneal dialysis (PD). It may expand the available knowledge of the clinical pharmacology of icodextrin following its intraperitoneal administration and fills the gaps in our understanding of the fate of icodextrin and the metabolic consequences of icodextrin and its metabolites.",[74],"Peritoneal Dialysis",[21,76,77],"Pharmacokinetics","Peritoneal dialysis","NOT_YET_RECRUITING","2024-08-10",{"date":81,"type":82},"2024-08-14","ACTUAL",{"date":84,"type":68},"2024-08-15",{"date":86,"type":68},"2025-03-30",{"name":5,"class":6},1]