Colchicine and Dialysis Patients: Feasibility Study Protocol

01 Apr 20264 min read0 viewsJournal Feed

GIST

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.

Clinical Editorial

Study intent and design

Aimed at determining whether future trials of colchicine in dialysis patients are feasible.
Design described as open-label, single-centre, single-arm.
Enrolment target of 100 participants to inform progression decisions for a larger trial.

Primary feasibility parameters

The principal outcome is overall feasibility and the determination of whether to advance to a full-scale study.
Feasibility judgments will rely on consent rates and rates of colchicine discontinuation.

Secondary feasibility and data-handling objectives

Evaluate the practicality of collecting data on quality of life, vascular access interventions, and safety.
Assess the usefulness of electronic health records for trial data capture.
Explore stakeholder experiences and attitudes toward colchicine and the feasibility study itself, including patients and healthcare providers.

Context on intervention and rationale

Colchicine has been associated with reduced cardiovascular events in some settings and may have antiproliferative benefits relevant to arteriovenous fistulas used in haemodialysis.
Despite potential benefits, colchicine is commonly avoided in dialysis populations, underscoring the need for feasibility data before a larger trial.

Ethics, dissemination, and registration

Ethics approval obtained from Wales REC (6; 24/WA/0277).
Results planned for publication in peer-reviewed journals.
Trial registration: ISRCTN91308625.

Limitations and openness about uncertainty

The summary reflects information explicitly reported; the article does not provide numerical feasibility thresholds or detailed progression criteria beyond stated aims.