Actively Recruiting

Phase 2
Age: 21Years - 80Years
All Genders
NCT04500665

Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Led by Brigham and Women's Hospital · Updated on 2025-09-23

20

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.

CONDITIONS

Official Title

Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years to 80 years (inclusive)
  • Estimated glomerular filtration rate (eGFR) of 15 to 75 mL/min per 1.73 m2
  • Urine albumin-to-creatinine ratio 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 is greater than 300 mg/g
  • Use of a sodium-glucose co-transporter-2 inhibitor if indicated by the participant's primary clinician
  • Willing and able to provide written informed consent and adhere to the study protocol
Not Eligible

You will not qualify if you...

  • History of intolerance or allergy to colchicine
  • Hospitalization for any reason within the previous 30 days
  • Acute condition requiring emergent treatment as judged by a physician investigator
  • Stage C or D heart failure according to ACC-AHA criteria
  • Left ventricular ejection fraction less than 40%
  • Symptomatic valvular heart disease
  • Congenital heart disease, corrected or uncorrected
  • History of orthotopic heart transplant
  • Kidney failure requiring transplant or dialysis
  • Worsening kidney function or acute kidney injury within the previous 30 days
  • Use of immunosuppressive or anti-inflammatory medications within the previous 30 days, except limited NSAIDs or corticosteroids for acute resolved conditions
  • Familial Mediterranean Fever, gout with flare in 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 increasing pneumonia risk as judged by a physician investigator
  • Surgery within the previous 30 days or planned during the study period
  • Current malignancy or treatment for malignancy within the previous year
  • Frailty or shortened life expectancy due to comorbidities increasing risk
  • Neutrophil count below 2,000 cells/mm3
  • Platelet count below 50,000 cells/mm3
  • Use of certain P-gp or CYP3A4 inhibitors
  • Use of medications causing myopathy or rhabdomyolysis or elevated creatine kinase levels
  • Moderate to severe liver disease (Child-Pugh B or C)
  • Pregnant or unwilling/unable to use appropriate contraception
  • Breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

L

Leo F Buckley, PharmD MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine | DecenTrialz