Colchicine in dialysis patients: a feasibility test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study will enroll adults on haemodialysis at a large renal center to receive colchicine 0.5 mg once daily for 3 months and 2 weeks. No control group is included to maximize data on tolerability and safety in this specific patient population. Blood tests for liver function, blood counts, and creatinine kinase will be collected at baseline, two weeks, and then monthly during dialysis sessions, with no extra visits. Participants will be contacted by phone on day 2 and at monthly intervals to report adverse effects, and quality of life surveys will be completed at baseline and after 3 months. The primary aim is to assess tolerability of low-dose colchicine in dialysis patients, with secondary observations on safety markers and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Anyone who is undergoing haemodialysis.
2. Aged 18 or over
3. Able to give informed consent

Exclusion Criteria:

1. Already taking colchicine for a clinical indication.
2. Taking a drug known to increase colchicine levels.
3. Has a previously documented intolerance of or allergy to colchicine
4. Has a history of chronic liver disease, or abnormal liver function (i.e. ALT \> 1.5 x upper limit of normal). Patients with a history of hepatitis are eligible provided these limits are not exceeded.

Where it's running

• Guy's and St Thomas' NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Dr Michael Robson — King's College London
• Study coordinator: Dr Dorothy Wong
• Email: dorothy.wong@kcl.ac.uk
• Phone: +44 (0)20 7188 3563

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using low-dose colchicine to treat acute coronary syndromes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.