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

Area of Science:

• Cardiovascular Research
• Nephrology
• Clinical Trial Design

Background:

• Colchicine shows potential cardiovascular benefits and improved arteriovenous fistula outcomes in haemodialysis patients due to antiproliferative effects.
• Colchicine is frequently avoided in dialysis patients, necessitating feasibility data for future large-scale trials.
• Assessing feasibility is crucial before initiating extensive clinical trials on colchicine for dialysis populations.

Purpose of the Study:

• To evaluate the feasibility of conducting future clinical trials involving colchicine in patients undergoing dialysis.
• To determine the viability of large-scale trials by assessing key feasibility metrics.

Main Methods:

• An open-label, single-center, single-arm study involving 100 participants.
• Primary feasibility outcomes include patient consent and colchicine discontinuation rates.
• Secondary objectives involve assessing data collection procedures for quality-of-life, vascular access interventions, safety, and electronic health record utility.

Main Results:

• Feasibility will be determined by the consent rate and colchicine discontinuation rate.
• The study will provide data on the practicality of collecting secondary outcome measures.
• Patient and healthcare provider perspectives on colchicine and feasibility studies will be explored.

Conclusions:

• The study's findings will guide the decision to proceed with a full-scale trial of colchicine in dialysis patients.
• Successful feasibility will pave the way for larger investigations into colchicine's benefits in this population.
• This research is essential for advancing the understanding and potential application of colchicine in renal care.