[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641194":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HAHD Group","EXPERIMENTAL","Participants assigned to this group will receive a combination of hemodialysis (HD) and hemoadsorption (HA) therapy.",[13],"Device: pHA130 Hemoadsorption Cartridge",{"label":15,"type":16,"description":17,"interventionNames":18},"HD Group","ACTIVE_COMPARATOR","Participants assigned to this group will receive standard maintenance hemodialysis therapy.",[19],"Device: High-flux Hemodialyzer",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","pHA130 Hemoadsorption Cartridge","Following a 4-week run-in period,patients receive High-flux hemodialysis (HD) twice a week and combined HAHD once a week. During the HAHD session, the pHA130 hemoadsorption cartridge is placed in series with a high-flux dialyzer. Each treatment session lasts for 4 hours.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"High-flux Hemodialyzer","Patients receive conventional high-flux hemodialysis (HD) three times a week. Each treatment session lasts for 4 hours.",[15],[32],{"name":33,"affiliation":5,"role":34},"Wenge Li, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Jian Lu, PhD","CONTACT","+8619834515101","lujiandr@163.com",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":26},"Shimin Jiang, PhD",[44],{"facility":5,"status":45,"city":46,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":26,"phoneExt":26,"email":26},"Jian Lu",{"type":34,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Wenge Li, MD, PhD","Professor",[62],{"name":63,"class":6},"Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine","100641194","efficacy-of-pha130-hemoadsorption-on-protein-bound-uremic-toxins-and-quality-of-life-in-kidney-failure-100641194",false,"NCT07656168","Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure","A Prospective, Multicenter, Randomized Controlled Trial of HAHD With pHA130 Cartridge vs. Conventional High-Flux HD for Clearance of Protein-Bound Uremic Toxins and Quality of Life Improvement in Kidney Failure.","PHOENIX","Inclusion Criteria:\n\n* Age \\> 18 years.\n* On maintenance hemodialysis for \\> 3 months.\n* Receiving hemodialysis 3 times per week, 4 hours per session.\n* Standard Kt\u002FV ≥ 1.2.\n* Voluntarily participates and provides written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to the dialyzer or hemoperfusion device.\n* Platelet count \\\u003C 60×10⁹\u002FL.\n* Serum albumin \\\u003C 30 g\u002FL.\n* 24-hour urine output \\> 200 ml.\n* Inability to achieve a blood flow rate ≥ 200 ml\u002Fmin.\n* Coagulation disorders, severe bleeding tendency, or active bleeding.\n* Pre-dialysis systolic blood pressure \\\u003C 90 mmHg or diastolic blood pressure \\\u003C 60 mmHg.\n* Active malignancy.\n* Active infection, or severe, critical illness of cardiac, pulmonary, hepatic, or nervous systems.\n* Planned living-donor kidney transplant within the next 6 months.\n* Current participation in another interventional clinical study, or participation within the past 3 months in an interventional study that may interfere with the present study (e.g., fecal microbiota transplantation); or use of intestinal microecological regulators such as probiotics.\n* History of unstable angina, myocardial infarction, malignant arrhythmia, cardiac or peripheral vascular surgery, or cerebrovascular accident within the past 8 weeks.","ALL","18 Years",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"NA","Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). The accumulation of these toxins is associated with adverse long-term outcomes.\n\nThis study evaluates the efficacy and safety of the pHA130 hemoadsorption cartridge, which utilizes a modified resin for enhanced PBUT adsorption, when combined with hemodialysis (HAHD). This is a prospective, open-label, multi-center, randomized controlled trial involving 100 MHD patients. Participants will be randomized 1:1 to either the HAHD group (receiving one HAHD session using the pHA130 cartridge and two standard HD sessions weekly) or the Control group (receiving three standard HD sessions weekly).\n\nThe primary objective is to assess the reduction in serum indoxyl sulfate (IS) and p-cresol sulfate (PCS) levels from baseline to 12 months. Secondary objectives include evaluating changes in quality of life (KDQoL-SF, MMSE), the progression of coronary artery calcification (CAC), the incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety profiles. This trial aims to determine if integrating long-term HAHD therapy can optimize blood purification strategies for the MHD population.",[82,83],"ESRD (End-Stage Renal Disease)","Maintenance Hemodialysis",[85,86,87,88,89,90],"Hemoadsorption","Protein-Bound Uremic Toxins","Indoxyl Sulfate","p-Cresyl Sulfate","Cardiovascular Events","Quality of Life","2026-06-22",{"date":93,"type":94},"2026-06-25","ACTUAL",{"date":96,"type":94},"2026-06-01",{"date":98,"type":76},"2028-08",{"name":5,"class":6},1]