Could a common gout pill protect kidneys and hearts?
NCT ID NCT04500665
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether colchicine, an anti-inflammatory drug, can improve heart function in people with chronic kidney disease. Researchers will measure changes in heart strain using ultrasound. The trial aims to enroll 20 adults aged 21-80 with moderate to severe kidney disease.
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 it works, this could point toward a simple, low-cost way to protect the heart in people with chronic kidney disease.
- What could go wrong
- This is a very small, early-phase trial with only 20 participants. It may not show a clear benefit, and colchicine can cause side effects like stomach upset.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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.
A. Inclusion Criteria: * Age 21 years to 80 years (inclusive) * eGFR of 15 to 75 mL/min per 1.73 m2 * Urine albumin-to-creatinine ratio of greater than 30 mg/g * Use of maximally tolerated doses of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker if urine albumin-to-creatinine ratio greater than 300 mg-g * Use of a sodium-glucose co-transporter-2 inhibitor if indicated in the opinion of the participant's primary clinician * Willing and able to provide written informed consent and to adhere to the study protocol B. Exclusion Criteria: 1. History of intolerance or allergy to colchicine 2. Hospitalization for any reason within the previous 30 days 3. Acute condition that requires emergent treatment in the opinion of a physician investigator 4. Stage C or D heart failure according to ACC-AHA criteria77 5. Left ventricular ejection fraction less than 40% 6. Symptomatic valvular heart disease 7. Congenital heart disease (corrected or uncorrected) 8. History of orthotopic heart transplant 9. Kidney failure, defined as kidney transplant recipient or requirement for hemodialysis or peritoneal dialysis 10. Worsening kidney function or acute kidney injury, defined as an increase in serum creatinine of greater than 0.3 mg/dL in the previous 30 days or 50% within the previous 7 days 11. Use of immunosuppressive or anti-inflammatory medications within the previous 30 days, with the exception of less than 5 days of non-steroidal anti-inflammatory drugs or corticosteroids for acute pain or other acute conditions that have since fully resolved provided that the last dose of non-steroid anti-inflammatory drug was at least 7 days before enrollment 12. Familial Mediterranean Fever, gout (unless no flare within the previous 12 months), pericarditis or other indications for colchicine treatment 13. Use of systemic antimicrobial therapy within the previous 30 days or active infection 14. History of respiratory illness that, in the opinion of a physician investigator, may increase the risk of pneumonia 15. Surgery within the previous 30 days or surgery planned to occur within the expected study period 16. Current malignancy or receipt of treatment for malignancy within the previous 1 year 17. Frailty or life-expectancy shortened by comorbidity such as cancer that would increase the participant's risk in the opinion of a physician investigator 18. Neutrophil count \< 2,000 cells/mm3 19. Platelet count \< 50,000 cells/mm3 20. Concomitant use of a P-gp inhibitor (e.g., cyclosporine, ranolazine, digoxin) and/or moderate-strong CYP3A4 inhibitor (e.g., clarithromycin, indinavir, itraconazole, ritonavir, nefazodone, diltiazem, verapamil, grapefruit juice, fluconazole) 21. Medications that may cause myopathy or rhabdomyolysis (i.e., simvastatin, gemfibrozil, fenofibrate) , a creatine kinase level after the run-in period that exceeds the upper limit of the normal laboratory reference range (if baseline was below the upper limit) or that increases by 50% or more from pre- to post-run-in 22. Moderate-severe hepatic disease (Child-Pugh B or C) 23. Pregnant or unwilling/unable to assure appropriate contraception 24. Breastfeeding
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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