[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594238":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":10,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group",null,"Treatment regimen: Hemodialysis (HD)\u002FHemodiafiltration (HDF) combined with Hemoperfusion (HP) using the pHA130 hemoperfusion device, with HD administered twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.",[13,14],"Device: pHA130 hemoperfusion device","Device: HD\u002FHDF",{"label":16,"type":10,"description":17,"interventionNames":18},"control group 1","Control Group 1: HD\u002FHDF Treatment regimen: HD twice weekly, HDF once weekly, with each session lasting 4 hours.",[14],{"label":20,"type":10,"description":21,"interventionNames":22},"control group 2","Control Group 2: HD\u002FHDF combined with HP (HA130 hemoperfusion device) Treatment regimen: HD twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.",[14,23],"Device: HA130 hemoperfusion device",[25,30,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DEVICE","pHA130 hemoperfusion device","HP once every 2 weeks.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"HD\u002FHDF","HD twice weekly, HDF once weekly, with each session lasting 4 hours.",[16,20,9],{"type":26,"name":35,"description":28,"armGroupLabels":36,"otherNames":10},"HA130 hemoperfusion device",[20],[38],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Wei Lu","CONTACT","8602125078999","luwei03@xinhuamed.com.cn",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":10},"Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200092","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100594238","effects-of-pha-hemoperfusion-plus-hemodialysis-on-protein-bound-uremic-toxins-100594238",false,"NCT07016841","Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins","Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study","Inclusion Criteria:\n\n1. Age ≥18 years, with no restriction on gender;\n2. Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;\n3. Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.\n\nExclusion Criteria:\n\n1. Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;\n2. Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;\n3. Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;\n4. Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;\n5. Patients with a platelet count \\\u003C 60 × 10⁹\u002FL;\n6. Other conditions deemed unsuitable for enrollment in this study by the researchers.","ALL","18 Years",{"count":70,"type":71},120,"ESTIMATED","OBSERVATIONAL","This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Adults on thrice-weekly, 4-hour HD for at least three months are randomized to one of three arms: HD\u002FHDF alone; HD\u002FHDF plus biweekly pHA130 hemoperfusion; or HD\u002FHDF plus biweekly HA130 hemoperfusion. After a four-week washout, toxin levels are measured at baseline and again at Weeks 4, 12, and 24, with the primary endpoint being the reduction in IS and PCS at Week 24. Secondary endpoints include single-session toxin removal, middle-molecule clearance (β₂-microglobulin, PTH), patient-reported outcomes (itching, sleep, quality of life), and rates of hospitalization and mortality. Safety is closely monitored through adverse event reporting and consistent anticoagulation dosing. Findings will clarify the clinical value of pHA130 hemoperfusion for improving toxin clearance and guiding optimal dialysis strategies.",[75],"End Stage Renal Disease on Dialysis",[77,78],"Hemoadsorption","Hemodialysis","2025-06-10",{"date":81,"type":82},"2025-06-12","ACTUAL",{"date":84,"type":82},"2025-05-12",{"date":86,"type":71},"2026-06-30",{"name":5,"class":6},1]