Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide, Virtual Weight Management Coaching.
- Who it may be relevant to
- Registry conditions: Obesity, Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)
Overview
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?
Interventions
- Drug Semaglutide
Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg. - 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.
Primary outcome measures
- Feasibility of Recruitment [Time frame: 12 months]
Secondary outcome measures (12)
- Adherence to Scheduled Coaching Visits [Time frame: 12 months]
- Adherence to GLP-1RA Therapy [Time frame: 12 months]
- Recruitment of ≥20 Participants in First 12 Weeks [Time frame: First 12 weeks]
- Recruitment Per Site Within 12 Weeks [Time frame: First 12 weeks]
- Incidence of Acute Kidney Injury [Time frame: 12 months]
- Incidence of Hypoglycemia [Time frame: 12 months]
- Incidence of Gastrointestinal Side Effects [Time frame: 12 months]
- Change in Dalhousie Clinical Frailty Scale Classification [Time frame: 26 weeks]
- Change in SARC-F Score of Sarcopenia [Time frame: 26 weeks]
- Change in Body Weight - Smart Scale [Time frame: 26 weeks]
- Change in Body Fat - Smart Scale [Time frame: 26 weeks]
- Change in Muscle Mass - Smart Scale [Time frame: 26 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity)
- Type 1 diabetes
- No access to semaglutide via drug coverage
- Pregnant, breastfeeding or planning to become pregnant
- Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- London Health Sciences Centre — London
Identifiers
NCT: NCT06396416 · OK-TRANSPLANT 2