[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659015":3},{"organization":4,"outcomesModule":7,"designInfo":155,"detailedDescription":158,"studyPopulation":158,"armGroups":162,"interventions":174,"overallOfficials":194,"centralContacts":202,"locations":209,"responsibleParty":232,"collaborators":158,"id":236,"slug":237,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":238,"sex":243,"minAge":244,"maxAge":158,"enrollmentInfo":245,"targetDuration":158,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":158,"overallStatus":257,"whyStopped":158,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},{"fullName":5,"class":6},"Western University, Canada","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":127},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Body Weight","Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts)","Baseline to 26 weeks +\u002F- 14 days",[14,17,20,23,26,29,32,36,39,42,45,49,52,55,58,61,65,68,71,74,77,80,83,86,89,92,95,98,101,104,108,111,114,118,121,124],{"measure":15,"description":16,"timeFrame":12},"Quality of Life - Kidney Disease Quality of Life 36-Item Short Form","Change in Kidney Disease Quality of Life (KDQOL-36) score across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.",{"measure":18,"description":19,"timeFrame":12},"Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire","Change in health-related quality of life measured using the European Quality of Life 5-Dimension, 5-Level questionnaire across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).",{"measure":21,"description":22,"timeFrame":12},"Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)","Change in functional status measured with KDQOL-36™ scores across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.",{"measure":24,"description":25,"timeFrame":12},"Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.","Measured via EQ-5D-5L (European Quality of Life five-dimensional, five-level generic measure) scores across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).",{"measure":27,"description":28,"timeFrame":12},"Weight Loss ≥5%","Percentage of participants achieving at least 5% reduction in body weight from baseline.",{"measure":30,"description":31,"timeFrame":12},"Weight Loss ≥10%","Percentage of participant achieving at least 10% reduction in body weight from baseline.",{"measure":33,"description":34,"timeFrame":35},"Weight Loss ≥15%","Percentage of participants achieving at least 15% reduction in body weight from baseline.","26 weeks +\u002F- 14 days",{"measure":37,"description":38,"timeFrame":12},"Weight Loss ≥20%","Percentage of participants achieving at least 20% reduction in body weight from baseline.",{"measure":40,"description":41,"timeFrame":12},"Body Mass Index (BMI)","Change in BMI across treatment arms. Measured in kg\u002Fm²",{"measure":43,"description":44,"timeFrame":12},"Body Surface Area (BSA)","Change in BSA across treatment arms. Measured in m².",{"measure":46,"description":47,"timeFrame":48},"Body Mass Index \u003C35 kg\u002Fm²","Percentage of participants achieving a BMI below \\\u003C35 kg\u002Fm², corresponding to the specified weight-based threshold for transplant listing.","Week 26 +\u002F- 14 days",{"measure":50,"description":51,"timeFrame":12},"Dalhousie Clinical Frailty Scale Rating","Change in Dalhousie Clinical Frailty Scale rating across treatment arms. The scale ranges from 1 (very fit) to 9 (terminally ill).",{"measure":53,"description":54,"timeFrame":12},"SARC-F Score","Change in sarcopenia measured by SARC-F score across treatment arms. This questionnaire is scored out of 10, with a score of 4 or higher indicating probable sarcopenia.",{"measure":56,"description":57,"timeFrame":12},"FRAIL Scale","Change in frailty measured by the FRAIL Scale across treatment arms. The scale scores five components - fatigue, resistance, ambulation, illnesses, and loss of weight - on a 0-5 scale, with 0 indicating robust, 1-2 pre-frail, and 3 or more indicating frailty.",{"measure":59,"description":60,"timeFrame":12},"Acute Kidney Injury (AKI)","Incidence of AKI. AKI defined by KDIGO as creatinine ≥ 1.5x baseline within 7 days in non-dialysis participants",{"measure":62,"description":63,"timeFrame":64},"Hypoglycemia","Incidence of hypoglycemia (blood glucose \\\u003C4 mmol\u002FL or time below target using continuous glucose monitoring)","Baseline to week 26 +\u002F- 14 days",{"measure":66,"description":67,"timeFrame":12},"Gastrointestinal Symptoms","Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation",{"measure":69,"description":70,"timeFrame":12},"Acute Biliary Disease","Incidence of acute biliary disease.",{"measure":72,"description":73,"timeFrame":12},"Acute Pancreatitis","Incidence of acute pancreatitis.",{"measure":75,"description":76,"timeFrame":12},"Diabetic Retinopathy Interventions","Incidence of interventions for diabetic retinopathy",{"measure":78,"description":79,"timeFrame":12},"Injection-site reactions","Incidence of injection-site reactions in the intervention arm.",{"measure":81,"description":82,"timeFrame":12},"Malignant Neoplasms","Incidence of malignant neoplasms.",{"measure":84,"description":85,"timeFrame":12},"Coaching Visit Adherence","Percentage of participants completing ≥4 of 6 coaching visits.",{"measure":87,"description":88,"timeFrame":12},"Semaglutide Discontinuation","Percentage of participants discontinuing semaglutide in the intervention arm.",{"measure":90,"description":91,"timeFrame":48},"Achievement of semaglutide dose ≥1.0 mg\u002Fweek","Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg\u002Fweek.",{"measure":93,"description":94,"timeFrame":35},"Achievement of Semaglutide Dose ≥2.0 mg\u002Fweek","Percentage of participants achieving a semaglutide dose of ≥2.0 mg\u002Fweek",{"measure":96,"description":97,"timeFrame":12},"Semaglutide Initiation in Usual Care","Percentage of usual care arm participants initiating semaglutide during the study period.",{"measure":99,"description":100,"timeFrame":12},"Use of Semaglutide in Usual Care Participants","Percentage of participants using semaglutide in the usual care arm.",{"measure":102,"description":103,"timeFrame":35},"Semaglutide Dose ≥1.0 mg\u002FWeek in Usual care Arm","Percentage of usual care participants achieving semaglutide dose ≥1.0 mg\u002Fweek",{"measure":105,"description":106,"timeFrame":107},"Semaglutide Dose ≥2.0 mg\u002FWeek in Usual Care Arm","Percentage of usual care participants achieving semaglutide dose ≥2.0 mg\u002Fweek","26 Weeks +\u002F- 14 days",{"measure":109,"description":110,"timeFrame":12},"Body Fat Percentage Measured with Smart Scale","Change in body fat percentage among the subsample of intervention participants using the study smart scale.",{"measure":112,"description":113,"timeFrame":12},"Muscle Mass Measured with Smart Scale","Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale.",{"measure":115,"description":116,"timeFrame":117},"Intervention Costs","The total cost of the intervention incurred by participants during the 26-week follow-up period, in Canadian dollars (CAD)","Baseline to 26 weeks",{"measure":119,"description":120,"timeFrame":117},"Out-of-pocket costs","Total out-of-pocket costs incurred by participants during the 26-week study period-including costs directly related to the intervention. Measured in Canadian dollars (CAD)",{"measure":122,"description":123,"timeFrame":117},"Lost Productivity Costs","Costs associated with productivity losses during the 26-week follow-up period, including costs directly related to the participant's health care and intervention. Measured in Canadian dollars (CAD)",{"measure":125,"description":126,"timeFrame":117},"Health care utilization costs","Total costs associated with health care utilization during the study period, including physician visits, hospitalizations, emergency department visits, medications, allied health services. Measured in Canadian dollars (CAD) using provincial administrative health data.",[128,132,135,138,141,144,148,152],{"measure":129,"description":130,"timeFrame":131},"Change in HbA1c","Change in glycated hemoglobin among participants with diabetes across treatment arms.","Baseline to 24 Months",{"measure":133,"description":134,"timeFrame":131},"Hospitalization for Hyperglycemia","Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms",{"measure":136,"description":137,"timeFrame":131},"Hospitalization for hypoglycemia","Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms.",{"measure":139,"description":140,"timeFrame":131},"Initiation of Dialysis","Percentage of non-dialysis participants initiating dialysis across treatment arms",{"measure":142,"description":143,"timeFrame":131},"Cardiovascular Composite","Composite of hospitalization for acute myocardial infarction, stroke, amputation, or heart failure across treatment arms.",{"measure":145,"description":146,"timeFrame":147},"Kidney Transplantation","Percentage of participants receiving kidney transplantation across treatment arms.","Baseline to 24 months",{"measure":149,"description":150,"timeFrame":151},"Healthcare utilization","Health care utilization over 24 months including number of hospital admissions, emergency department, outpatient and primary care visits, specialist visits, rehabilitation, allied health care visits. Measured using provincial administrative health data.","24 months",{"measure":153,"description":154,"timeFrame":151},"Health care costs","Health care costs over 24 months, including total health care costs, hospitalization-related costs, emergency department costs, outpatient and physician costs, medication costs. Measured in Canadian dollars (CAD) using provincial administrative health data.",{"allocation":156,"interventionModel":157,"interventionModelDescription":158,"primaryPurpose":159,"observationalModel":158,"timePerspective":158,"maskingInfo":160},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":161,"maskingDescription":158,"whoMasked":158},"NONE",[163,170],{"label":164,"type":165,"description":166,"interventionNames":167},"Virtual Weight Management Program","EXPERIMENTAL","A maximum tolerated dose of semaglutide will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.",[168,169],"Drug: Semaglutide","Behavioral: Virtual Weight Management Coaching",{"label":171,"type":172,"description":173,"interventionNames":158},"Usual Care","NO_INTERVENTION","Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.",[175,186],{"type":176,"name":177,"description":178,"armGroupLabels":179,"otherNames":180},"DRUG","Semaglutide","Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.",[164],[181,182,183,184,185],"Wegovy","Ozempic","Generic Semaglutide","Apo-Semaglutide","Semaglutide Injection",{"type":187,"name":188,"description":189,"armGroupLabels":190,"otherNames":191},"BEHAVIORAL","Virtual Weight Management Coaching","Virtual meeting with intervention coach once every 4 weeks for 6 months, where the coach will discuss the goals and progress with participant, nutritional advice, exercise advice, and motivational support.",[164],[192,193],"Coaching","Weight Management",[195,199],{"name":196,"affiliation":197,"role":198},"Kristin Clemens, MD","St. Joseph's Health Care London, Western University","PRINCIPAL_INVESTIGATOR",{"name":200,"affiliation":201,"role":198},"Louise Moist, MD","London Health Sciences Centre",[203],{"name":204,"role":205,"phone":206,"phoneExt":207,"email":208},"Heather LaPier","CONTACT","519-646-6100","65373","heather.lapier@sjhc.london.on.ca",[210,225],{"facility":211,"status":158,"city":212,"state":213,"zip":214,"country":215,"countryCode":216,"cosmosGeoPoint":217,"geoPoint":222,"contacts":223},"St. Joseph's Health Care","London","Ontario","N6A4V2","Canada","CA",{"type":218,"coordinates":219},"Point",[220,221],-81.23304,42.98339,{"lat":221,"lon":220},[224],{"name":204,"role":205,"phone":206,"phoneExt":207,"email":208},{"facility":201,"status":158,"city":212,"state":213,"zip":158,"country":215,"countryCode":216,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},{"type":218,"coordinates":227},[220,221],{"lat":221,"lon":220},[230],{"name":231,"role":205,"phone":206,"phoneExt":207,"email":208},"Heather LaPier, MD",{"type":233,"investigatorFullName":234,"investigatorTitle":235,"investigatorAffiliation":5,"oldNameTitle":158,"oldOrganization":158},"SPONSOR_INVESTIGATOR","Kristin Clemens","Dr.","100659015","phase-4-patient-centred-intervention-with-virtual-support-for-obesity-and-kidney-transplant-access-100659015",false,"NCT07858331","Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access","PIVOT","Inclusion Criteria:\n\n* 18 years or older\n* BMI \\>35 kg\u002Fm2\n* eGFR \\\u003C15ml\u002Fmin\u002F1.73m2 at baseline OR 2-year KFRE2 of 10% or greater\n\nExclusion Criteria:\n\n* Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)\n* Type 1 diabetes","ALL","18 Years",{"count":246,"type":247},880,"ESTIMATED","INTERVENTIONAL",[250],"PHASE4","Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.\n\nThe investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.\n\nThe investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.",[253,254,255,256],"Obesity","Chronic Kidney Disease","Chronic Renal Disease","CKD","NOT_YET_RECRUITING","2026-09-28",{"date":260,"type":261},"2026-10-05","ACTUAL",{"date":263,"type":247},"2027-01-01",{"date":265,"type":247},"2029-01-01",{"name":234,"class":6},2]