Colchicine and dialysis patients (CAD): protocol for a feasibility study

INTRODUCTION: Colchicine has been shown to reduce cardiovascular events and may improve outcomes in arteriovenous fistulas used for haemodialysis due to antiproliferative effects. However, it is often avoided in patients receiving dialysis. Therefore, a large trial assessing the potential benefits of colchicine in dialysis patients cannot begin without further data on feasibility. The primary objective of this study is to assess the feasibility of carrying out future trials of colchicine in dialysis patients. METHODS AND ANALYSIS: This is an open-label, single centre, single arm study with 100 participants. The primary outcome is feasibility and the decision to progress to a full-scale trial. This will be based on the consent rate and the colchicine discontinuation rate. Secondary objectives are testing the feasibility of data collection procedures relating to quality-of-life measures, vascular access interventions and safety. Other secondary objectives are to assess the utility of the electronic health record for collecting trial data and to explore patients' and healthcare providers' experiences and attitudes towards colchicine and a feasibility study. ETHICS AND DISSEMINATION: The study has Research Ethics Committee approval (Wales REC 6; 24/WA/0277). It is intended that the results of the study will be reported in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: ISRCTN91308625.