NCT04500665 Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine
| NCT ID | NCT04500665 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2021-11-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.
Eligibility Criteria
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
Contact & Investigator
Leo F Buckley, PharmD MPH
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT04500665 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04500665 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04500665 currently recruiting?
Yes, NCT04500665 is actively recruiting participants. Contact the research team at lfbuckley@bwh.harvard.edu for enrollment information.
Where is the NCT04500665 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04500665 clinical trial?
NCT04500665 is sponsored by Brigham and Women's Hospital. The principal investigator is Leo F Buckley, PharmD MPH at Brigham and Women's Hospital. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.