Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

NCT04500665 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2020P002468K23HL150311
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Between-group change in left ventricular global longitudinal strain

  Assessed using transthoracic echocardiography

  4 weeks

Secondary Outcomes (4)

• Between-group change in left ventricular systolic and diastolic function

  4 weeks

• Between-group change in left ventricular volumes

  4 weeks

• Between-group change in left ventricular size

  4 weeks

• Between-group change in systemic inflammation

  4 weeks

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 0.3 mg once daily

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

Colchicine DRUG

Colchicine

Colchicine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Leo F Buckley, PharmD MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo F Buckley, PharmD MPH

CONTACT

617-732-5500; lfbuckley@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 5, 2020
• Study Start: November 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)