[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502943":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":48,"responsibleParty":196,"collaborators":198,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":26,"eligibilityCriteria":207,"healthyVolunteers":203,"sex":208,"minAge":209,"maxAge":26,"enrollmentInfo":210,"targetDuration":26,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clinically-matched Incremental Hemodialysis ( CMIHD)","EXPERIMENTAL","Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.",[13],"Device: Hemodialysis twice weekly",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Hemodialysis (CHD)","ACTIVE_COMPARATOR","Randomized group to conventional three times a week hemodialysis.",[19],"Other: Hemodialysis thrice weekly",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Hemodialysis twice weekly","Frequency and duration of hemodialysis is tailored to the patient. Adjuvant pharmacotherapy is prescribed to maintain volume, electrolyte and acid-base homeostasis ( e.g., diuretics, sodium bicarbonate and potassium binding patiromer)",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Hemodialysis thrice weekly","Conventional hemodialysis regimen",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Mariana Murea, MD","Wake Forest Health Sciences","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Peter Kotanko","Renal Research Institute",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Brenda Burciu","CONTACT","336-716-8671","Brindusa.Burciu@advocatehealth.org",{"name":46,"role":42,"phone":26,"phoneExt":26,"email":47},"Ben Bagwell","Benjamin.Bagwell@advocatehealth.org",[49,69,84,97,113,129,144,159,172,183],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Florida","RECRUITING","Jacksonville","Florida","32209","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-81.65565,30.33218,{"lat":61,"lon":60},[64,67],{"name":65,"role":42,"phone":26,"phoneExt":26,"email":66},"Alaa Awad, MD","Alaa.Awad@jax.ufl.edu",{"name":68,"role":35,"phone":26,"phoneExt":26,"email":26},"Alaa Awad",{"facility":70,"status":51,"city":71,"state":72,"zip":73,"country":55,"countryCode":56,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Emory University","Atlanta","Georgia","30322",{"type":58,"coordinates":75},[76,77],-84.38798,33.749,{"lat":77,"lon":76},[80,83],{"name":81,"role":42,"phone":26,"phoneExt":26,"email":82},"Vandana Dua Niyyar","vniyyar@emory.edu",{"name":81,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":85,"status":51,"city":86,"state":87,"zip":88,"country":55,"countryCode":56,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Johns Hopkins University School of Medicine (JHUSM)","Baltimore","Maryland","21218",{"type":58,"coordinates":90},[91,92],-76.61219,39.29038,{"lat":92,"lon":91},[95],{"name":96,"role":35,"phone":26,"phoneExt":26,"email":26},"Gautam Samir, MD",{"facility":98,"status":51,"city":99,"state":100,"zip":101,"country":55,"countryCode":56,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":58,"coordinates":103},[104,105],-71.05977,42.35843,{"lat":105,"lon":104},[108,112],{"name":109,"role":42,"phone":110,"phoneExt":26,"email":111},"Sagar Nigwekar","617-726-5050","SNIGWEKAR@mgh.harvard.edu",{"name":109,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":114,"status":51,"city":115,"state":116,"zip":117,"country":55,"countryCode":56,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"University of Mississippi Medical Center","Jackson","Mississippi","39216",{"type":58,"coordinates":119},[120,121],-90.18481,32.29876,{"lat":121,"lon":120},[124,128],{"name":125,"role":42,"phone":126,"phoneExt":26,"email":127},"Neville Dossabhoy, MD","601-984-5670","ndossabhoy@umc.edu",{"name":125,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":130,"status":51,"city":131,"state":131,"zip":132,"country":55,"countryCode":56,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Renal Research Institute (RRI)","New York","10065",{"type":58,"coordinates":134},[135,136],-74.00597,40.71427,{"lat":136,"lon":135},[139,143],{"name":140,"role":42,"phone":141,"phoneExt":26,"email":142},"Rasha Hussein, MD","212-331-1710","rasha.hussein@rriny.com",{"name":140,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":145,"status":51,"city":146,"state":131,"zip":147,"country":55,"countryCode":56,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Northwell Health","Queens","11427",{"type":58,"coordinates":149},[150,151],-73.83652,40.68149,{"lat":151,"lon":150},[154,158],{"name":155,"role":42,"phone":156,"phoneExt":26,"email":157},"Steven Fishbane","516-465-8200","Sfishbane@northwell.edu",{"name":155,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":160,"status":51,"city":161,"state":162,"zip":163,"country":55,"countryCode":56,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"University of North Carolina Chapel Hill","Chapel Hill","North Carolina","27599",{"type":58,"coordinates":165},[166,167],-79.05584,35.9132,{"lat":167,"lon":166},[170],{"name":171,"role":35,"phone":26,"phoneExt":26,"email":26},"Jennifer Flythe, MD",{"facility":173,"status":51,"city":174,"state":162,"zip":175,"country":55,"countryCode":56,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Atrium Health Wake Forest Baptist","Winston-Salem","27157",{"type":58,"coordinates":177},[178,179],-80.24422,36.09986,{"lat":179,"lon":178},[182],{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":184,"status":51,"city":185,"state":186,"zip":187,"country":55,"countryCode":56,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University of Virginia (UVA)","Charlottesville","Virginia","22904",{"type":58,"coordinates":189},[190,191],-78.47668,38.02931,{"lat":191,"lon":190},[194],{"name":195,"role":35,"phone":26,"phoneExt":26,"email":26},"Emaad Abdel-Rahman, MD",{"type":197,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[199],{"name":200,"class":6},"Patient-Centered Outcomes Research Institute","100502943","incremental-hemodialysis-the-twoplus-trial-100502943",false,"NCT05828823","Incremental Hemodialysis: The TwoPlus Trial","Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis","Patient eligibility Criteria:\n\nInclusion Criteria:\n\n* Clinical Inclusion Criteria:\n* Age ≥ 18 years\n* Incident kidney dysfunction requiring dialysis (KDRD) started on maintenance, in-center hemodialysis (HD), or anticipated to be started on maintenance, in-center HD within the next 12 weeks\n* Has received ≤36 sessions of intermittent HD (i.e., on HD for ≤12 weeks) at the time patient is approached for potential study participation\n\nResidual Kidney Function Inclusion Criteria:\n\n* Kidney urea clearance \\\u003C2.0 mL\u002Fmin\n* Urine volume# of ≥500 mL\u002F24 h\n\nExclusion Criteria:\n\n* Pre-HD serum K ≥5.8 mEq\u002FL, Na ≤125 mEq\u002FL, or bicarbonate level ≤17 mEq\u002FL\n* Requirement or anticipated requirement of high-volume ultrafiltration\n* Unable or unwilling to follow the study protocol for any reason\n* Known pregnancy or planning to attempt to become pregnant or lactating women\n* Estimated survival or dialysis modality change or center transfer \\\u003C6 months\n\nCaregiver Eligibility Criteria:\n\n* be at least 18 years old\n* be the main caregiver (at patient's choice)\n* be a close relative of the patient (spouse, child, sibling, parent, grandchild)\n* have no known psychiatric and neurologic disorders (through direct inquiry from the person)\n* not be a member of the medical or healthcare team\n* not be the caregiver for another patient with chronic illness\n* not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)","ALL","18 Years",{"count":211,"type":212},350,"ESTIMATED","INTERVENTIONAL",[215],"NA","This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function.\n\nThe study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.",[218],"End-Stage Kidney Disease",[220,221],"Hemodialysis","Clinically-Matched Incremental Hemodialysis","2026-05-20",{"date":224,"type":225},"2026-05-22","ACTUAL",{"date":227,"type":225},"2024-02-26",{"date":229,"type":212},"2031-01",{"name":5,"class":6},10]