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

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.

Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.

• Оземпик
• Вегови
• Generic Semaglutide
• Apo-Semaglutide
• Semaglutide Injection

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.

• Управление весом
• Коучинг

Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts)

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.

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).

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.

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).

Percentage of participants achieving at least 5% reduction in body weight from baseline.

Percentage of participant achieving at least 10% reduction in body weight from baseline.

Percentage of participants achieving at least 15% reduction in body weight from baseline.

Percentage of participants achieving at least 20% reduction in body weight from baseline.

Change in BMI across treatment arms. Measured in kg/m²

Change in BSA across treatment arms. Measured in m².

Percentage of participants achieving a BMI below <35 kg/m², corresponding to the specified weight-based threshold for transplant listing.

Change in Dalhousie Clinical Frailty Scale rating across treatment arms. The scale ranges from 1 (very fit) to 9 (terminally ill).

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.

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.

Incidence of AKI. AKI defined by KDIGO as creatinine ≥ 1.5x baseline within 7 days in non-dialysis participants

Incidence of hypoglycemia (blood glucose <4 mmol/L or time below target using continuous glucose monitoring)

Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation

Incidence of acute biliary disease.

Incidence of acute pancreatitis.

Incidence of interventions for diabetic retinopathy

Incidence of injection-site reactions in the intervention arm.

Incidence of malignant neoplasms.

Percentage of participants completing ≥4 of 6 coaching visits.

Percentage of participants discontinuing semaglutide in the intervention arm.

Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg/week.

Percentage of participants achieving a semaglutide dose of ≥2.0 mg/week

Percentage of usual care arm participants initiating semaglutide during the study period.

Percentage of participants using semaglutide in the usual care arm.

Percentage of usual care participants achieving semaglutide dose ≥1.0 mg/week

Percentage of usual care participants achieving semaglutide dose ≥2.0 mg/week

Change in body fat percentage among the subsample of intervention participants using the study smart scale.

Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale.

The total cost of the intervention incurred by participants during the 26-week follow-up period, in Canadian dollars (CAD)

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)

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)

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.

Change in glycated hemoglobin among participants with diabetes across treatment arms.

Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms

Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms.

Percentage of non-dialysis participants initiating dialysis across treatment arms

Composite of hospitalization for acute myocardial infarction, stroke, amputation, or heart failure across treatment arms.

Percentage of participants receiving kidney transplantation across treatment arms.

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.

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.