Obesity management for kidney TRANSPLANTation: protocol for the vanguard phase of an innovative randomised controlled trial, embedded in routine care (OK-TRANSPLANT 2).

Kristin K Clemens, Jennifer Irwin, Michael Chiu, Stephanie Dixon, Natalie J Bendo, Phil Varughese, Amanda J Vinson, Heather Lapier, David Attalla, Jaclyn Ernst, Tayyab Khan, Ann Young, Kevin Yau, Laura Craig, Sonja Reichert, Alp Sener, Louise M Moist

Journal: BMJ open 2026;16(8):e120427

PMID: 42580835

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Abstract

BACKGROUND

Large randomised controlled trials (RCTs) of obesity interventions have excluded those with advanced chronic kidney disease (CKD) including recipients of dialysis. Obesity management is critically important to their health and healthcare, including their ability to access kidney transplant.

OBJECTIVE

To describe the vanguard phase of a large, pragmatic, open-label RCT testing the effectiveness of a multi-component weight management programme vs standard of obesity care in advanced CKD.

METHODS

We are conducting an open-label RCT evaluating a 26-week multicomponent weight management programme (inclusive of monthly virtual coaching; semaglutide to a maximum dose of 2.0 mg/week; and behavioural, dietary and exercise counselling) for those with advanced CKD. Adults aged 18 years or older with a body mass index ≥35 kg/m² with or without diabetes, who are receiving dialysis or have >10% risk of end-stage kidney disease requiring renal replacement therapy over 2 years (based on the Kidney Failure Risk Equation) are included. Our primary success criterion is the recruitment of at least 50 participants (83% of target) within 12 months of site initiation Feasibility, adherence, safety and selected efficacy outcomes will be summarised descriptively. The acceptability of the intervention will be explored using qualitative methods. The study was initiated in September 2024 with a target completion date of December 2027.

TRIAL REGISTRATION

NCT06396416.

Address: Schulich School of Medicine, Western University, London, Ontario, Canada [email protected].; Endocrinology and Metabolism, Western University, London, Ontario, Canada.; Epidemiology and Biostatistics, Western University, London, Ontario, Canada.; Lawson Research Institute, London, Ontario, Canada.; Faculty of Health Sciences, Western University, London, Ontario, Canada.; London Health Sciences Centre, London, Ontario, Canada.; Nephrology, Western University, London, Ontario, Canada.; Schulich School of Medicine, Western University, London, Ontario, Canada.; Epidemiology and Biostatistics, Western University, London, Ontario, Canada.; London Health Sciences Centre Research Institute, London, Ontario, Canada.; Lawson Research Institute, London, Ontario, Canada.; Nephrology, Dalhousie University, Halifax, Nova Scotia, Canada.; Kidney Research Unit Nova Scotia, Halifax, Nova Scotia, Canada.; York Weight Loss Clinic, Toronto, Ontario, Canada.; Schulich School of Medicine, Western University, London, Ontario, Canada.; Schulich School of Medicine, Western University, London, Ontario, Canada.; Endocrinology and Metabolism, Western University, London, Ontario, Canada.; Centre for Diabetes, Endocrinology and Metabolism, St Joseph's Health Care London, London, Ontario, Canada.; Nephrology, Unity Health Toronto, Toronto, Ontario, Canada.; Nephrology, University Health Network, Toronto, Ontario, Canada.; London Health Sciences Centre, London, Ontario, Canada.; Schulich School of Medicine, Western University, London, Ontario, Canada.; Family Medicine, Western University, London, Ontario, Canada.; Schulich School of Medicine, Western University, London, Ontario, Canada.; Urology, Western University, London, Ontario, Canada.; Schulich School of Medicine, Western University, London, Ontario, Canada.; Epidemiology and Biostatistics, Western University, London, Ontario, Canada.; London Health Sciences Centre, London, Ontario, Canada.; Nephrology, Western University, London, Ontario, Canada.

DOI: 10.1136/bmjopen-2026-120427

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MeSH Terms: Humans, Kidney Transplantation, Obesity, Semaglutide, Obesity Management, Female, Adult, Kidney Failure, Chronic, Glucagon-Like Peptide 1, Body Mass Index, Renal Insufficiency, Chronic, Male, Anti-Obesity Agents, Weight Reduction Programs