Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access (PIVOT)

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.

The 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.

The 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Chronic Kidney Disease; CKD; Chronic Renal Disease
• Intervention / Treatment: Drug: Semaglutide; Behavioral: Virtual Weight Management Coaching

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heather LaPier; Phone Number: 65373 519-646-6100; Email: heather.lapier@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre
      • Contact: Heather LaPier, MD; Phone Number: 65373 519-646-6100; Email: heather.lapier@sjhc.london.on.ca
    • London, Ontario, Canada, N6A4V2
      • St. Joseph's Health Care
      • Contact: Heather LaPier; Phone Number: 65373 519-646-6100; Email: heather.lapier@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older
• BMI >35 kg/m2
• eGFR <15ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater

Exclusion Criteria:

• Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)
• Type 1 diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Weight Management Program; 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.	Drug: Semaglutide; Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.; Other Names: Ozempic; Wegovy; Generic Semaglutide; Apo-Semaglutide; Semaglutide Injection; 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.; Other Names: Weight Management; Coaching
No Intervention: Usual Care; Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 +/- 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 26 weeks +/- 14 days
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).	Baseline to 26 weeks +/- 14 days
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.	Baseline to 26 weeks +/- 14 days
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).	Baseline to 26 weeks +/- 14 days
Weight Loss ≥5%	Percentage of participants achieving at least 5% reduction in body weight from baseline.	Baseline to 26 weeks +/- 14 days
Weight Loss ≥10%	Percentage of participant achieving at least 10% reduction in body weight from baseline.	Baseline to 26 weeks +/- 14 days
Weight Loss ≥15%	Percentage of participants achieving at least 15% reduction in body weight from baseline.	26 weeks +/- 14 days
Weight Loss ≥20%	Percentage of participants achieving at least 20% reduction in body weight from baseline.	Baseline to 26 weeks +/- 14 days
Body Mass Index (BMI)	Change in BMI across treatment arms. Measured in kg/m²	Baseline to 26 weeks +/- 14 days
Body Surface Area (BSA)	Change in BSA across treatment arms. Measured in m².	Baseline to 26 weeks +/- 14 days
Body Mass Index <35 kg/m²	Percentage of participants achieving a BMI below <35 kg/m², corresponding to the specified weight-based threshold for transplant listing.	Week 26 +/- 14 days
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).	Baseline to 26 weeks +/- 14 days
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.	Baseline to 26 weeks +/- 14 days
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.	Baseline to 26 weeks +/- 14 days
Acute Kidney Injury (AKI)	Incidence of AKI. AKI defined by KDIGO as creatinine ≥ 1.5x baseline within 7 days in non-dialysis participants	Baseline to 26 weeks +/- 14 days
Hypoglycemia	Incidence of hypoglycemia (blood glucose <4 mmol/L or time below target using continuous glucose monitoring)	Baseline to week 26 +/- 14 days
Gastrointestinal Symptoms	Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation	Baseline to 26 weeks +/- 14 days
Acute Biliary Disease	Incidence of acute biliary disease.	Baseline to 26 weeks +/- 14 days
Acute Pancreatitis	Incidence of acute pancreatitis.	Baseline to 26 weeks +/- 14 days
Diabetic Retinopathy Interventions	Incidence of interventions for diabetic retinopathy	Baseline to 26 weeks +/- 14 days
Injection-site reactions	Incidence of injection-site reactions in the intervention arm.	Baseline to 26 weeks +/- 14 days
Malignant Neoplasms	Incidence of malignant neoplasms.	Baseline to 26 weeks +/- 14 days
Coaching Visit Adherence	Percentage of participants completing ≥4 of 6 coaching visits.	Baseline to 26 weeks +/- 14 days
Semaglutide Discontinuation	Percentage of participants discontinuing semaglutide in the intervention arm.	Baseline to 26 weeks +/- 14 days
Achievement of semaglutide dose ≥1.0 mg/week	Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg/week.	Week 26 +/- 14 days
Achievement of Semaglutide Dose ≥2.0 mg/week	Percentage of participants achieving a semaglutide dose of ≥2.0 mg/week	26 weeks +/- 14 days
Semaglutide Initiation in Usual Care	Percentage of usual care arm participants initiating semaglutide during the study period.	Baseline to 26 weeks +/- 14 days
Use of Semaglutide in Usual Care Participants	Percentage of participants using semaglutide in the usual care arm.	Baseline to 26 weeks +/- 14 days
Semaglutide Dose ≥1.0 mg/Week in Usual care Arm	Percentage of usual care participants achieving semaglutide dose ≥1.0 mg/week	26 weeks +/- 14 days
Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm	Percentage of usual care participants achieving semaglutide dose ≥2.0 mg/week	26 Weeks +/- 14 days
Body Fat Percentage Measured with Smart Scale	Change in body fat percentage among the subsample of intervention participants using the study smart scale.	Baseline to 26 weeks +/- 14 days
Muscle Mass Measured with Smart Scale	Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale.	Baseline to 26 weeks +/- 14 days
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
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)	Baseline to 26 weeks
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)	Baseline to 26 weeks
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.	Baseline to 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Change in glycated hemoglobin among participants with diabetes across treatment arms.	Baseline to 24 Months
Hospitalization for Hyperglycemia	Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms	Baseline to 24 Months
Hospitalization for hypoglycemia	Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms.	Baseline to 24 Months
Initiation of Dialysis	Percentage of non-dialysis participants initiating dialysis across treatment arms	Baseline to 24 Months
Cardiovascular Composite	Composite of hospitalization for acute myocardial infarction, stroke, amputation, or heart failure across treatment arms.	Baseline to 24 Months
Kidney Transplantation	Percentage of participants receiving kidney transplantation across treatment arms.	Baseline to 24 months
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
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.	24 months

Collaborators and Investigators

• Sponsor: Kristin Clemens
• Investigators: Principal Investigator: Kristin Clemens, MD, St. Joseph's Health Care London, Western University; Principal Investigator: Louise Moist, MD, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 28, 2026
• First Posted (Actual): October 5, 2026

Study Record Updates

• Last Update Posted (Actual): October 5, 2026
• Last Update Submitted That Met QC Criteria: September 28, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Overnutrition; Body Weight; Renal Insufficiency; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Renal Insufficiency, Chronic; semaglutide
• Other Study ID Numbers: PIVOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No