RecruitingNAINTERVENTIONAL

Colchicine And Dialysis Patients; a Feasibility Study

This study is investigating an old, inexpensive medicine called colchicine in people who are on kidney dialysis. Past studies, not including dialysis patients, suggest colchicine might help prevent heart attacks and strokes. It might also help keep the special connections (fistulas) used for dialysis working longer. Doctors often avoid giving colchicine to dialysis patients due to concerns about side effects, as these patients often take many medications already. This initial study will give a low dose of colchicine to 100 dialysis patients for about three months. The main goal is to find out if it's safe and well-tolerated by these patients. The results will help researchers decide if larger studies into colchicine's potential benefits for dialysis patients should go ahead.

At a glance

Status

Recruiting

Phase

Sponsor

King's College London

Enrolment target

100

Start

10 Apr 2025

Estimated completion

01 Nov 2027

Haemodialysis Patients Colchicine Feasibility Study

What is this study about?

This study is looking at a medicine called colchicine, which has been around for many years and is quite inexpensive. Previous research on people who don't have kidney disease suggests that colchicine could help reduce the risk of serious problems like heart attacks and strokes. However, we don't know if these benefits would also apply to people receiving kidney dialysis, as they are often more complex cases.

Another reason colchicine might be helpful for dialysis patients is for something called an 'arteriovenous fistula'. This is a special connection made in the arm between an artery and a vein, which allows blood to be easily accessed for dialysis treatment. Sometimes, these fistulas can narrow, making them harder to use. Some treatments for narrowed fistulas use medicines similar to colchicine, so researchers think colchicine might help keep these fistulas working properly for longer.

Currently, doctors are often careful about giving colchicine to dialysis patients because these patients usually take many other medicines and can have other health conditions. This means there's a worry that dialysis patients might have more trouble with side effects from colchicine. This small study, called a 'feasibility study', aims to see if a low dose of colchicine is safe and acceptable for dialysis patients. If it is, this would be an important step towards planning much larger studies to see if colchicine can truly help dialysis patients live longer and keep their dialysis access working well.

Key takeaways

This is a small study checking if colchicine is safe and well-tolerated by people on kidney dialysis.
It aims to see if a low dose causes too many side effects in this patient group.
Colchicine is an old medicine that may help prevent heart problems and keep dialysis fistulas working.
Participants will take colchicine daily for about 3.5 months.
No extra hospital visits are needed; checks are done during regular dialysis and by phone.
The results will help decide if bigger studies should be done.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and currently receiving kidney dialysis (specifically, haemodialysis). You must also be able to understand the study and agree to take part.

There are a few reasons why you might not be able to join. For example, if you're already taking colchicine for another health condition, or if you're on medicines that could increase the amount of colchicine in your body to unsafe levels, you wouldn't be able to participate.

You also can't join if you've had a bad reaction or allergy to colchicine in the past, or if you have severe liver problems. If you've had hepatitis in the past, you might still be eligible as long as your liver is currently working well.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently receiving regular haemodialysis?
Are you able to understand and agree to take part in the study?
Have you ever had a serious reaction or allergy to colchicine?
Do you have a history of serious liver problems?
Are you currently taking colchicine or medicines that could dangerously increase its levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will take a low dose of colchicine once a day for a little over three months (specifically, three months and two weeks). You won't need to make any extra trips to the hospital. Blood tests will be taken during your regular dialysis sessions, at the start, after two weeks, and then once a month. These blood tests will check things like your blood count and how your liver is working.

A nurse or researcher will call you by phone on day two of the study and then monthly after that, at the same time as your blood tests, to ask how you're feeling and if you've had any side effects. You will also be asked to fill out a short questionnaire about your quality of life at the beginning and again at the end of the study. The total time you'd be involved in the study is about three and a half months.

Potential risks and benefits

This study aims to find out if low-dose colchicine is safe and well-tolerated in dialysis patients, which could help lead to future studies exploring potential benefits for heart health and dialysis access. However, there's no guarantee that you personally will experience any direct health benefits from taking part in this specific study. Like all medicines, colchicine can have side effects, and the study team will carefully monitor you for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Guy's and St Thomas' NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is haemodialysis?

Haemodialysis is a treatment that filters waste and extra fluid from your blood when your kidneys can no longer do this properly.

What is a feasibility study?

A feasibility study is a small, early-stage study that checks if a larger study is possible and practical. It helps researchers understand if a medicine is acceptable and safe enough for a specific group of patients before planning a big trial.

Will I get a placebo (dummy pill)?

No, everyone in this study will receive the low-dose colchicine. There is no placebo group in this particular study.

What are arteriovenous fistulas?

These are special connections made under the skin, usually in your arm, between an artery and a vein. They provide a strong, easy-to-access place for the needles used during dialysis treatments.

How long will I take the medicine?

You will take the low-dose colchicine once a day for about three months and two weeks.

How to find out more

Dr Dorothy Wong

dorothy.wong@kcl.ac.uk +44 (0)20 7188 3563 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.