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

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.