Status:
RECRUITING
Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.
Eligibility Criteria
Inclusion
- A.
- 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
- History of intolerance or allergy to colchicine
- Hospitalization for any reason within the previous 30 days
- Acute condition that requires emergent treatment in the opinion of a physician investigator
- Stage C or D heart failure according to ACC-AHA criteria77
- Left ventricular ejection fraction less than 40%
- Symptomatic valvular heart disease
- Congenital heart disease (corrected or uncorrected)
- History of orthotopic heart transplant
- Kidney failure, defined as kidney transplant recipient or requirement for hemodialysis or peritoneal dialysis
- 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
- 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
- Familial Mediterranean Fever, gout (unless no flare within the previous 12 months), pericarditis or other indications for colchicine treatment
- Use of systemic antimicrobial therapy within the previous 30 days or active infection
- History of respiratory illness that, in the opinion of a physician investigator, may increase the risk of pneumonia
- Surgery within the previous 30 days or surgery planned to occur within the expected study period
- Current malignancy or receipt of treatment for malignancy within the previous 1 year
- Frailty or life-expectancy shortened by comorbidity such as cancer that would increase the participant's risk in the opinion of a physician investigator
- Neutrophil count \< 2,000 cells/mm3
- Platelet count \< 50,000 cells/mm3
- 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)
- 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
- Moderate-severe hepatic disease (Child-Pugh B or C)
- Pregnant or unwilling/unable to assure appropriate contraception
- Breastfeeding
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 11 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04500665
Start Date
November 1 2021
End Date
November 11 2026
Last Update
September 23 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115