Can a common gout pill shield hearts in kidney disease?
NCT ID NCT06203977
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether colchicine, a drug used for gout, can safely reduce inflammation and potentially lower heart injury in people with advanced chronic kidney disease or on dialysis. Participants take colchicine daily for 16 weeks, starting at a low dose and then increasing it. The main goal is to see how well people tolerate the drug and whether they can stick with it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine
- What this could lead to
- If colchicine is well-tolerated, it could point toward a way to lower heart risk in people with kidney disease.
- What could go wrong
- This is a small, early-phase trial focused on tolerance, not on proving heart benefits. Colchicine can cause side effects like stomach upset, and the results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
96 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. One of either: 1.2 Estimated GFR using CKD-EPI 2021 equation of ≤30 ml/min/1.73m2 on at least two occasions separated by at least 2 months and do not yet require dialysis and are not expected by their treating nephrologist to require dialysis in the next 6 months (REPAIR CKD cohort), or 1.3 receiving chronic maintenance dialysis 2 or more times per week for the previous 90 days (REPAIR Dialysis cohort); 2. Age ≥18 years 3. Provide informed consent to participate. Exclusion Criteria: 1. Currently treated with and cannot withdraw colchicine due to medical necessity; or 2. Known allergy/sensitivity to colchicine; or 3. Prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower; or 4. Currently pregnant or planning to become pregnant or breastfeed during the study; or 5. Of childbearing potential AND do not have a negative pregnancy test OR do not agree to use two forms of contraception for the duration of the study; or 6. Anticipated living donor renal transplant within the next 6 months; or 7. Using a strong inhibitor of p-glycoprotein or strong inhibitor of CYP3A4 in the last 14 days; or 8. B12 deficiency not managed with intramuscular supplementation; or 9. Uncontrolled chronic diarrhea; or 10. Cirrhosis, or chronic active hepatitis; or 11. Pre-existent neuromuscular disease or persistent serum CK level \> 3 times the upper limit of normal as measured within the past 60 days and determined to be non-transient through repeat testing; or 12. Patient with any of the following within the past 60 days: * white blood cell count \< 3.0 X 109/L; or * platelet count \<110 X 109/L; or * ALT or AST \> 3 times the upper limit of normal (ULN); or * total bilirubin \> 2 times ULN and not due to Gilbert syndrome. 13. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
-
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
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University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
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