Colchicine for coronary protection on dialysis (CCPD)
Colchicine for coronary protection on dialysis (CCPD): A prospective, non-randomised, open-label interventional cohort study examining the pharmacokinetics and pharmacodynamics of colchicine in patients on maintenance intermittent haemodialysis
Sydney Local Health District
20 participants
Nov 3, 2025
Interventional
Conditions
Summary
The drug colchicine has been shown to be effective for cardiovascular disease prevention in the general population but is there is limited data available on colchicine in patients who are receiving haemodialysis for end-stage kidney disease. This project will aim to study the drug colchicine in patients who are receiving haemodialysis by examining for accumulation of colchicine, adverse effects of colchicine and effectiveness at colchicine at limiting inflammation markers. Three doses of colchicine will be used: 0.25mg three times weekly, 0.5mg three times weekly and 0.5mg daily. Participants will receive each dose of colchicine for 2 weeks sequentially. Findings from this study will provide a basis for larger clinical trials using colchicine in patients on haemodialysis.
Eligibility
Inclusion Criteria3
- Aged 18 to 75 years
- Currently receiving haemodialysis in Royal Prince Alfred Hospital dialysis unit three times per week
- Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion Criteria10
- Commenced maintenance intermittent haemodialysis < 6 weeks ago
- Current infection
- Previously documented hypersensitivity to colchicine
- Prior diagnosis of cirrhosis or severe hepatic impairment
- Concurrently taking a strong P-gp inhibitor medication or strong CYP3A4 inhibitor medication or other medication listed in Prohibited Medications List
- Positive beta-HCG in female patients who are of child-bearing age
- Taken colchicine in the past 30 days for any indication
- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
- Participants who may have received an investigational new drug within the last 30 days
- Circumstances/conditions which may interfere with the participant’s ability to give informed consent.
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Interventions
Participants will be given oral colchicine 0.25 mg three times per week for 2 weeks - this will be according to their regular haemodialysis session schedule, either Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. Each participant will commence the trial on their second haemodialysis session of the week (either Wednesday or Thursday) in order to avoid the longer weekend break before the first session of the week. The medication will be administered at the end of the haemodialysis session. Following the above, the participants will then increase dose to 0.5 mg three times per week for 2 weeks (using the same administration schedule as above) and then finally increase to 0.5 mg daily for 2 weeks. When on daily dosing, the participants will take the medication at the same time every day. Adherence will be monitored by drug tablet return.
Locations(1)
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ACTRN12625001063404