INFILTRATE Study - Work package 3 Feasibility Study

• Research type

  Research Study

• Full title

  INFILTRATE: ImplemeNtation of a Formula low energy diet programme for weight loss In a renaL TRansplAnT sErvice Study - Work package 3 Feasibility Study

• IRAS ID

  365381

• Contact name

  Adrian Brown

• Contact email

  a.c.brown@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2025/11/75, Data protection registration; 183844, Edge ID

• Duration of Study in the UK

  2 years, 3 months, 0 days

• Research summary

  Obesity affects 28% of UK adults and is associated with chronic kidney disease and kidney failure (KF), resulting overtime in the requirement for kidney replacement therapy (dialysis/transplantation). Almost 30,000 UK adults are on dialysis, with data from London showing 29% of people on dialysis are living with obesity.

  Dialysis impacts on patient’s quality of life, mental health and increases their change of early death. Therefore, access to transplantation is a clinical priority.

  Despite guidelines stating that obesity (body mass index; BMI≥30kg/m2) should not preclude kidney transplantation, about 30% are excluded with obesity reducing the likelihood of being listed for and having a transplant, while weight loss increases transplant likelihood.

  Therefore. the overall aim of this study is to assess the feasibility, acceptability, and safety of a formula low energy diet (LED) lifestyle programme to help people living obesity and KF on haemodialysis (HD) to lose weight and be listed for a KT. This study will test the trial methodology procedures and limited efficacy testing to demonstrate if a full-scale RCT is possible.

  Participants will be randomised to either the formula LED lifestyle programme or usual care with 12 months follow up. The primary objectives of the feasibility study will be two-fold: feasibility outcomes and mean difference in dry weight at 12 months.

  • We hypothesise a formula LED lifestyle programme will be feasible, acceptable, and safe in people living with obesity and KF on HD.
  • We hypothesise a formula LED lifestyle programme compared to usual care will result in greater weight loss.

  The study design will be a multi-centre prospective parallel two-arm randomised feasibility study conducted at three kidney units in London. We plan to recruit 72 participants living with obesity and KF on HD who are waiting to be list for transplantation.
  

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  26/SC/0041

• Date of REC Opinion

  24 Feb 2026

• REC opinion

  Further Information Favourable Opinion