Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2
- Conditions
- Chronic Kidney DiseaseObesity
- Interventions
- Behavioral: Virtual Weight Management Coaching
- Registration Number
- NCT06396416
- Lead Sponsor
- Western University, Canada
- Brief Summary
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.
- Detailed Description
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:
1. Is participant recruitment into a large multi-centered trial feasible?
2. Will participants remain adherent to their assigned treatment arm over 26 weeks of study?
3. Will participants find our program acceptable?
4. Will safety events preclude us from testing our intervention in a larger RCT?
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Adults aged 18 years or older
- BMI > 35 kg/m^2
- >10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis
- Known contraindication to a GLP-1RA
- Type 1 diabetes
- Current use of more than the starting dose of semaglutide, liraglutide, or dulaglutide
- No access to semaglutide via drug coverage
- Absolute contraindication to kidney transplant
- Pregnant, breastfeeding or planning to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Weight Management Program Virtual Weight Management Coaching 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. Virtual Weight Management Program Semaglutide 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.
- Primary Outcome Measures
Name Time Method Recruitment Rate 12 months Number participants recruited within 12 months of trial initiation at each centre
- Secondary Outcome Measures
Name Time Method Adverse events 26 weeks Percentage of participants that experience acute kidney injury (AKI), hypoglycemia, gastrointestinal side effects.
Adherence to Scheduled Coaching Visits 26 weeks Percentage of participants randomized to the intervention attend \>75% of their scheduled coaching visits.
Adherence to Study Medication 26 weeks Percentage of participants randomized to the intervention fill \>75% of their semaglutide prescriptions.
Crossover of Intervention and Control 26 weeks Percentage of participants randomized to the usual care group who are started on a GLP-1RA medication or other weight loss intervention during the study
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada