[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653180":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":11,"studyPopulation":87,"armGroups":88,"interventions":101,"overallOfficials":11,"centralContacts":115,"locations":121,"responsibleParty":394,"collaborators":11,"id":396,"slug":397,"hasResults":398,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":11,"eligibilityCriteria":402,"healthyVolunteers":398,"sex":403,"minAge":404,"maxAge":405,"enrollmentInfo":406,"targetDuration":11,"studyType":409,"phases":11,"briefSummary":410,"conditions":411,"keywords":414,"overallStatus":124,"whyStopped":11,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":427},{"fullName":5,"class":6},"Vantive Health LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Patient survival rates",null,"6, 12, and 24 months",[14,18,21,24,26,28,31,33,35,37,39,42],{"measure":15,"description":16,"timeFrame":17},"Quality of Life Scores (EQ-5D-5L)","Change in quality of life scores measured using the EuroQol Five Dimensions (EQ-5D-5L) scales","6, 12 and 24 months",{"measure":19,"description":20,"timeFrame":12},"Quality of Life Scores (KDQOL-36)","Change in quality of life scores measured using the Kidney Disease Quality of Life-36 (KDQOL-36)",{"measure":22,"description":23,"timeFrame":12},"Social Reintegration","Social functioning and reintegration assessed using the Work and Social Adjustment Scale (WSAS)",{"measure":22,"description":25,"timeFrame":17},"Social functioning and reintegration assessed using the EQ-5D-5L",{"measure":22,"description":27,"timeFrame":17},"Social functioning and reintegration assessed using supplementary questionnaires",{"measure":29,"description":30,"timeFrame":12},"Healthcare Resource Utilization (Direct Medical Costs)","Assessment of healthcare resource utilization including hospitalization rate",{"measure":29,"description":32,"timeFrame":12},"Assessment of healthcare resource utilization including number of hospitalizations",{"measure":29,"description":34,"timeFrame":12},"Assessment of healthcare resource utilization including length of hospital stay",{"measure":29,"description":36,"timeFrame":12},"Assessment of healthcare resource utilization including outpatient and emergency visits",{"measure":29,"description":38,"timeFrame":12},"Assessment of healthcare resource utilization including total hospitalization costs",{"measure":40,"description":41,"timeFrame":12},"Healthcare workforce utilization","Time and resource utilization by healthcare providers per patient including remote communication collected via healthcare staff questionnaire",{"measure":43,"description":44,"timeFrame":12},"Healthcare Resource Utilization (Direct Non-Medical Costs and Indirect Costs)","Costs related to non-medical expenditures and productivity loss collected via patient questionnaires",[46,50,53,56,60,63,65,67,69,71,74,77,79,81],{"measure":47,"description":48,"timeFrame":49},"Incidence of infection-related complications","Infection related complications including but not limited to peritonitis, pulmonary infections, peritoneal dialysis catheter-related infections, hemodialysis catheter-related infections, and urinary tract infections.","1, 3, 6, 12, 18, and 24 months",{"measure":51,"description":52,"timeFrame":49},"Incidence of cardiovascular and cerebrovascular events","Cardiovascular events include but are not limited to acute myocardial infarction, angina, sudden cardiac death, heart failure, arrhythmia and other ischemic heart diseases. Cerebrovascular events include but are not limited to stroke, cerebral hemorrhage, and peripheral arterial disease.",{"measure":54,"description":55,"timeFrame":49},"Incidence of dialysis access-related complications","dialysis access-related complications including access-related infections and dysfunction for both PD and HD: Peritoneal dialysis catheter-related infections, Peritoneal dialysis catheter dysfunction, Hemodialysis access-related infections and Hemodialysis access dysfunction",{"measure":57,"description":58,"timeFrame":59},"Change from baseline in 24-hour urine output","For PD patients, 24-hour urine volume data is collected during dialysis adequacy assessment. For HD patients, 24-hour urine volume is the average volume over two consecutive days (a dialysis day and a non-dialysis day).","3, 12, and 24 months",{"measure":61,"description":62,"timeFrame":12},"Dialysis quality control indicators","The rate of achieving the standard for small molecule solute clearance",{"measure":61,"description":64,"timeFrame":12},"Hypertension control rate: The proportion of maintenance HD or PD patients meeting the blood pressure control targets during the assessment period",{"measure":61,"description":66,"timeFrame":12},"Renal anemia control rate: The proportion of maintenance HD or PD patients with hemoglobin (Hb) levels ≥ 110 g\u002FL during the assessment period",{"measure":61,"description":68,"timeFrame":12},"CKD-Mineral and Bone Disorder (CKD-MBD) indicators control rate: The proportion of maintenance HD or PD patients meeting the control standards for CKD-MBD indicators during the assessment period",{"measure":61,"description":70,"timeFrame":12},"Serum albumin control rate: The proportion of maintenance HD or PD patients with serum albumin levels ≥ 35 g\u002FL during the assessment period",{"measure":72,"description":73,"timeFrame":12},"Proportion of patients transferred to HD","Transferred to HD is defined as transfer from PD to HD for ≥ 30 consecutive days",{"measure":75,"description":76,"timeFrame":59},"Ultrafiltration volume and solute clearance","Collection of data from dialysis adequacy assessment including 24-hour ultrafiltration volume",{"measure":75,"description":78,"timeFrame":59},"Collection of data from dialysis adequacy assessment including weekly residual renal Kt\u002FV, weekly dialysis Kt\u002FV, and weekly total Kt\u002FV",{"measure":75,"description":80,"timeFrame":59},"Collection of data from dialysis adequacy assessment including weekly residual renal creatinine clearance (Ccr), weekly dialysis Ccr, and weekly total Ccr.",{"measure":82,"description":83,"timeFrame":49},"Change from baseline in blood pressure","Office blood pressure (OBP), defined as blood pressure (systolic and diastolic) measured in a healthcare setting by a physician, nurse, or other trained professional using a validated sphygmomanometer.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":85,"timePerspective":86,"maskingInfo":11},"COHORT","PROSPECTIVE","This study plans to screen Chinese patients receiving remote patient monitoring-automated peritoneal dialysis (RPM-APD), manual peritoneal dialysis (manual PD), or maintenance hemodialysis (HD). Each patient must meet all inclusion criteria and none of the exclusion criteria for this study. No exceptions are permitted under any circumstances.",[89,93,97],{"label":90,"type":11,"description":11,"interventionNames":91},"RPM-APD cohort",[92],"Device: Remote patient monitoring-automated peritoneal (RPM-APD)",{"label":94,"type":11,"description":11,"interventionNames":95},"Manual PD cohort",[96],"Device: Manual peritoneal dialysis (PD) cohort",{"label":98,"type":11,"description":11,"interventionNames":99},"HD cohort",[100],"Device: Maintenance hemodialysis (HD)",[102,107,111],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":11},"DEVICE","Remote patient monitoring-automated peritoneal (RPM-APD)","RPM-APD refers to peritoneal dialysis performed at home using an APD cycler, with the prescription, treatment process, monitoring, and management conducted via a remote management system.",[90],{"type":103,"name":108,"description":109,"armGroupLabels":110,"otherNames":11},"Manual peritoneal dialysis (PD) cohort","Manual PD refers to home-based dialysis exchange therapy performed by the patient\u002Fcaregiver according to the physician's prescription without the use of automated equipment.",[94],{"type":103,"name":112,"description":113,"armGroupLabels":114,"otherNames":11},"Maintenance hemodialysis (HD)","Maintenance HD refers to conventional hemodialysis therapy performed by professional staff in a dialysis center\u002Fhemopurification unit, initiated after the induction dialysis period.",[98],[116],{"name":117,"role":118,"phone":119,"phoneExt":11,"email":120},"Global CORP Clinical Trials Disclosure","CONTACT","+1 2249484283","Global.CORP.ClinicalTrialsDisclosure@vantive.com",[122,140,151,161,171,185,199,213,227,241,255,269,283,297,311,325,339,352,366,380],{"facility":123,"status":124,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":136},"China-Japan Friendship Hospital","RECRUITING","Beijing","Beijing Municipality","100029","China","CN",{"type":131,"coordinates":132},"Point",[133,134],116.39723,39.9075,{"lat":134,"lon":133},[137],{"name":138,"role":118,"phone":11,"phoneExt":11,"email":139},"Wenge Li","wenge_lee2002@126.com",{"facility":141,"status":142,"city":125,"state":126,"zip":143,"country":128,"countryCode":129,"cosmosGeoPoint":144,"geoPoint":146,"contacts":147},"Peking University First Hospital","NOT_YET_RECRUITING","100034",{"type":131,"coordinates":145},[133,134],{"lat":134,"lon":133},[148],{"name":149,"role":118,"phone":11,"phoneExt":11,"email":150},"Jie Dong","jie.dong@bjmu.edu.cn",{"facility":152,"status":142,"city":125,"state":126,"zip":153,"country":128,"countryCode":129,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"Beijing Haidian Hospital","100080",{"type":131,"coordinates":155},[133,134],{"lat":134,"lon":133},[158],{"name":159,"role":118,"phone":11,"phoneExt":11,"email":160},"Gang Fu","fugang126@126.com",{"facility":162,"status":142,"city":125,"state":126,"zip":163,"country":128,"countryCode":129,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},"Peking University Third Hospital","100191",{"type":131,"coordinates":165},[133,134],{"lat":134,"lon":133},[168],{"name":169,"role":118,"phone":11,"phoneExt":11,"email":170},"Wen Tang","tangwen@126.com",{"facility":172,"status":142,"city":173,"state":174,"zip":175,"country":128,"countryCode":129,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"The Second Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality","400010",{"type":131,"coordinates":177},[178,179],106.55771,29.56026,{"lat":179,"lon":178},[182],{"name":183,"role":118,"phone":11,"phoneExt":11,"email":184},"Xiaohui Liao","1263201771@qq.com",{"facility":186,"status":142,"city":187,"state":188,"zip":189,"country":128,"countryCode":129,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Guangdong Provincial Hospital of Traditional Chinese Medicine","Guangzhou","Guangdong","510120",{"type":131,"coordinates":191},[192,193],113.25,23.11667,{"lat":193,"lon":192},[196],{"name":197,"role":118,"phone":11,"phoneExt":11,"email":198},"Xusheng Liu","liuxu801@126.com",{"facility":200,"status":142,"city":201,"state":202,"zip":203,"country":128,"countryCode":129,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Hebei Medical University Third Hospital","Shijiazhuang","Hebei","050051",{"type":131,"coordinates":205},[206,207],114.47861,38.04139,{"lat":207,"lon":206},[210],{"name":211,"role":118,"phone":11,"phoneExt":11,"email":212},"Yanqing Chi","lilychi@sina.com",{"facility":214,"status":142,"city":215,"state":216,"zip":217,"country":128,"countryCode":129,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"The Second Affiliated Hospital of Harbin Medical University","Harbin","Heilongjiang","150001",{"type":131,"coordinates":219},[220,221],126.65,45.75,{"lat":221,"lon":220},[224],{"name":225,"role":118,"phone":11,"phoneExt":11,"email":226},"Xuanyi Du","dxy_shennei@126.com",{"facility":228,"status":142,"city":229,"state":230,"zip":231,"country":128,"countryCode":129,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Henan Provincial People's Hospital","Zhengzhou","Henan","450003",{"type":131,"coordinates":233},[234,235],113.64861,34.75778,{"lat":235,"lon":234},[238],{"name":239,"role":118,"phone":11,"phoneExt":11,"email":240},"Fengmin Shao","fengminshao@126.com",{"facility":242,"status":142,"city":243,"state":244,"zip":245,"country":128,"countryCode":129,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","430071",{"type":131,"coordinates":247},[248,249],114.26667,30.58333,{"lat":249,"lon":248},[252],{"name":253,"role":118,"phone":11,"phoneExt":11,"email":254},"Huiming Wang","736238012@qq.com",{"facility":256,"status":142,"city":257,"state":258,"zip":259,"country":128,"countryCode":129,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"The Third Xiangya Hospital of Central South University","Changsha","Hunan","410013",{"type":131,"coordinates":261},[262,263],112.97087,28.19874,{"lat":263,"lon":262},[266],{"name":267,"role":118,"phone":11,"phoneExt":11,"email":268},"Hao Zhang","Zhanghaoliaoqing@163.com",{"facility":270,"status":142,"city":271,"state":272,"zip":273,"country":128,"countryCode":129,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"The First Affiliated Hospital of Baotou Medical College","Baotou","Inner Mongolia","014010",{"type":131,"coordinates":275},[276,277],109.84389,40.6516,{"lat":277,"lon":276},[280],{"name":281,"role":118,"phone":11,"phoneExt":11,"email":282},"Lei Nan","nanlei566@163.com",{"facility":284,"status":142,"city":285,"state":286,"zip":287,"country":128,"countryCode":129,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Wuxi People's Hospital","Wuxi","Jiangsu","214023",{"type":131,"coordinates":289},[290,291],120.28857,31.56887,{"lat":291,"lon":290},[294],{"name":295,"role":118,"phone":11,"phoneExt":11,"email":296},"Liang Wang","wangliang_wuxi@126.com",{"facility":298,"status":142,"city":299,"state":300,"zip":301,"country":128,"countryCode":129,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"The Second Norman Bethune Hospital of Jilin University","Changchun","Jilin","130041",{"type":131,"coordinates":303},[304,305],125.32278,43.88,{"lat":305,"lon":304},[308],{"name":309,"role":118,"phone":11,"phoneExt":11,"email":310},"Wenpeng Cui","wenpengcui@163.com",{"facility":312,"status":142,"city":313,"state":314,"zip":315,"country":128,"countryCode":129,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an","Shaanxi","710061",{"type":131,"coordinates":317},[318,319],108.92861,34.25833,{"lat":319,"lon":318},[322],{"name":323,"role":118,"phone":11,"phoneExt":11,"email":324},"Jing Lv","drlvjing@163.com",{"facility":326,"status":142,"city":327,"state":328,"zip":329,"country":128,"countryCode":129,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"The Affiliated Hospital of Qingdao University","Qingdao","Shandong","266555",{"type":131,"coordinates":331},[332,333],120.38042,36.06488,{"lat":333,"lon":332},[336],{"name":337,"role":118,"phone":11,"phoneExt":11,"email":338},"Guangqun Xing","gqx99monash@163.com",{"facility":340,"status":142,"city":341,"state":328,"zip":342,"country":128,"countryCode":129,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Yantai Yuhuangding Hospital","Yantai","264000",{"type":131,"coordinates":344},[345,346],121.44081,37.47649,{"lat":346,"lon":345},[349],{"name":350,"role":118,"phone":11,"phoneExt":11,"email":351},"Peng Li","yhdgcplipeng@163.com",{"facility":353,"status":142,"city":354,"state":355,"zip":356,"country":128,"countryCode":129,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Shanghai Sixth People's Hospital","Shanghai","Shanghai Municipality","200233",{"type":131,"coordinates":358},[359,360],121.45806,31.22222,{"lat":360,"lon":359},[363],{"name":364,"role":118,"phone":11,"phoneExt":11,"email":365},"Niansong Wang","wangniansong2012@163.com",{"facility":367,"status":142,"city":368,"state":369,"zip":370,"country":128,"countryCode":129,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Tianjin First Central Hospital","Tianjin","Tianjin Municipality","300190",{"type":131,"coordinates":372},[373,374],117.17667,39.14222,{"lat":374,"lon":373},[377],{"name":378,"role":118,"phone":11,"phoneExt":11,"email":379},"Wenxiu Chang","changwx@sina.com",{"facility":381,"status":142,"city":382,"state":383,"zip":384,"country":128,"countryCode":129,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"Hangzhou Hospital of Traditional Chinese Medicine","Hangzhou","Zhejiang","310007",{"type":131,"coordinates":386},[387,388],120.16142,30.29365,{"lat":388,"lon":387},[391],{"name":392,"role":118,"phone":11,"phoneExt":11,"email":393},"Mengli Tong","1994185637@qq.com",{"type":395,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100653180","clinical-effectiveness-and-resource-use-in-end-stage-renal-disease-patients-remote-patient-monitoring-across-dialysis-modalities-100653180",false,"NCT07781124","Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities","Clinical Effectiveness and Healthcare Resource Utilization in Patients With End-Stage Renal Disease Receiving Remote Patient Monitoring-Automated Peritoneal Dialysis, Manual Peritoneal Dialysis, or Hemodialysis: A Multicenter, Prospective, Observational Real-World Study","Inclusion Criteria:\n\n* Aged ≥ 18 years and \\\u003C 80 years.\n* Diagnosed with ESRD and planned to initiate RPM-APD \u002F manual PD \u002F HD as maintenance dialysis within 3 months after signing the ICF.\n* Able to continue long-term follow-up and treatment at the study site after enrollment.\n* Voluntarily sign the ICF and are able to complete study visits and questionnaires as required by the Investigator or have a caregiver to assist in completing study-related procedures.\n\nExclusion Criteria:\n\n* Diagnosed with acute kidney injury (AKI).\n* Received dialysis therapy for more than 1 month.\n* History of kidney transplantation.\n* Presence of other severe diseases, such as malignancies with active or residual lesions despite treatment, systemic infections, decompensated liver cirrhosis, severe lactic acidosis, etc.\n* Patients with HIV infection or syphilis infection.\n* Presence of psychiatric disorders or inability to cooperate.\n* Pregnant or breastfeeding women, as well as women of childbearing potential unwilling to use effective contraception during the study period.\n* Currently participating in another interventional study or having participated in another interventional study within 1 month prior to enrollment.\n* Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.","ALL","18 Years","79 Years",{"count":407,"type":408},750,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, observational real-world study designed to evaluate clinical effectiveness, quality of life, and healthcare resource utilization in patients with end-stage renal disease (ESRD) initiating dialysis therapy in China.\n\nParticipants will be grouped according to the dialysis modality selected through routine clinical practice and shared decision-making with their treating physicians: remote patient monitoring-assisted automated peritoneal dialysis (RPM-APD), manual peritoneal dialysis (PD), or maintenance hemodialysis (HD). No study-specific interventions will be assigned.\n\nThe study will compare outcomes across these cohorts, including quality of life, social reintegration, clinical outcomes (e.g., complications and survival), and healthcare resource utilization. Propensity score matching will be applied to adjust for baseline differences between cohorts.",[412,413],"End Stage Renal Disease (ESRD)","Chronic Kidney Disease (CKD)",[415,416,417],"RPM-APD","Manual PD","Maintenance HD","2026-08-18",{"date":420,"type":421},"2026-08-24","ACTUAL",{"date":423,"type":421},"2026-06-17",{"date":425,"type":408},"2029-06-30",{"name":5,"class":6},20]