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| Name | Class |
|---|---|
| London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | OTHER |
| Queen Elizabeth II Health Sciences Centre | OTHER |
| Unity Health Toronto | OTHER |
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OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial.
We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.
Obesity is well-recognized as an independent risk factor for chronic kidney disease (CKD) including end-staged kidney disease (ESKD). In people with ESKD, obesity can preclude access to lifesaving kidney transplantation. Of solid organ transplant programs in Canada, 80% exclude people with obesity (based upon body mass index or BMI), due to a potential risk of perioperative complications and post-transplant mortality.
Losing weight for kidney transplantation can, however, be extremely difficult. Medications that can promote weight loss in other populations including glucagon-like peptide 1 receptor agonists (GLP-1RA; liraglutide, semaglutide, and dulaglutide) and glucose-dependent insulinotropic polypeptide (GIP-1RA)/GLP-1RAs (tirzepatide), have not been studied in devoted trials of advanced CKD participants, and their efficacy and safety remain unclear.
Nutritional advice is often very difficult to follow when trying to balance kidney and diabetes diets (e.g. potassium), and if diets are too restrictive, there may be protein-energy wasting which could be detrimental to patients. People with high-risk CKD frequently live with functional impairment which can limit exercise. Weight loss programs can be cost prohibitive to those who are already socioeconomically disadvantaged.
A vanguard is needed before a large, multicentered RCT: A feasibility study will allow us to ensure that we can recruit a sufficient sample of participants into our trial, that our trial processes are inclusive, and that they are acceptable to patients. In the vanguard phase of our trial, we will answer the following questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Weight Management Program | Experimental | A maximum tolerated dose of semaglutide (Ozempic/Wegovy) 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | Number of participants enrolled across three centers, with success defined as recruitment of ≥ 60 participants within the 12-month enrollment period. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Scheduled Coaching Visits | Percentage of participants randomized to the intervention attend >75% of their scheduled coaching visits. | 12 months |
| Adherence to GLP-1RA Therapy | Percentage of participants randomized to the intervention fill >75% of their semaglutide prescriptions. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Change in HbA1c | Percentage of change in HbA1c from baseline to 26 weeks, measured in percentage | 26 weeks |
| Change in 2-week glycemic variability | For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in 2-week glycemic variability from baseline to 26 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather LaPier, BSc | Contact | 519-646-6100 | 65373 | heather.lapier@sjhc.london.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kristin K Clemens, MD, MSc | St. Joseph's Health Care London | Principal Investigator |
| Louise Moist, MD, MSc | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5A5 | Canada |
Demographics (age, sex, etc.) Baseline characteristics Lab Values Outcome Measurements Adverse event data Other data points collected for each participant
Beginning immediately following publication; no end date
De-identified individual participant data will be made available to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the study investigators. Data will be provided following execution of an appropriate data use agreement.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Double: Double (Investigator, Outcomes Assessor)
| Virtual Weight Management Coaching | Behavioral | 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. |
|
| 12 months |
| Recruitment of ≥20 Participants in First 12 Weeks | Recruitment of ≥20 participants in first 12 Weeks of trial initiation | First 12 weeks |
| Recruitment Per Site Within 12 Weeks | At least one participant recruited per site within 12 weeks of trial initiation each active site | First 12 weeks |
| Incidence of Acute Kidney Injury | Number of participants experiencing acute kidney injury (AKI) | 12 months |
| Incidence of Hypoglycemia | Number of participants experiencing hypoglycemia | 12 months |
| Incidence of Gastrointestinal Side Effects | Number of participants experiencing GI side effects | 12 months |
| Change in Dalhousie Clinical Frailty Scale Classification | Change in participant's Dalhousie Clinical Frailty Scale Classification from baseline to 26 weeks. The scale has 9 options, from 1 (very fit) to 9 (terminally ill). | 26 weeks |
| Change in SARC-F Score of Sarcopenia | Change in participant's SARC-F questionnaire score from baseline to 26 weeks. Out of 8 points, a SARC-F score of ≥4 best predicts the need for further, more comprehensive clinical evaluation. | 26 weeks |
| Change in Body Weight - Smart Scale | Change in weight from baseline to 26 weeks, measured in kilograms. Measured using a Smart Scale in a subpopulation. | 26 weeks |
| Change in Body Fat - Smart Scale | Change in body fat from baseline to 26 weeks, measured in percentage. Measured using Smart Scale in subpopulation. | 26 weeks |
| Change in Muscle Mass - Smart Scale | Change in muscle mass from baseline to 26 weeks. Measured in kilograms. Measured using Smart Scale in subpopulation. | 26 weeks |
| Change in Body Water Content - Smart Scale | Change in body water content from baseline to 26 weeks. Measured in percentage. Measured using Smart Scale in subpopulation. | 26 weeks |
| In-Clinic Height Measurement | In-clinic height measurements, measured in centimeters | Baseline, 3 months, 6 months |
| In-Clinic Weight Measurement | In-clinic weight measurements, measured in kilograms | Baseline, 3 months, 6 months |
| In-Clinic Body Mass Index Measurement | In-clinic BMI measurements, measured in kg/m^2 | Baseline, 3 months, 6 months |
| 26 weeks |
| Change in Time-in-Range | For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in Time-in-Range from baseline to 26 weeks | 26 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |