Menu
Recruiting NCT04500665

Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Phase II Interventional Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colchicine, Placebo.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Colchicine
    Colchicine
  • Drug Placebo
    Placebo

Primary outcome measures

  • Between-group change in left ventricular global longitudinal strain [Time frame: 4 weeks]
Secondary outcome measures (4)
  • Between-group change in left ventricular systolic and diastolic function [Time frame: 4 weeks]
  • Between-group change in left ventricular volumes [Time frame: 4 weeks]
  • Between-group change in left ventricular size [Time frame: 4 weeks]
  • Between-group change in systemic inflammation [Time frame: 4 weeks]

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:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT04500665 · 2020P002468 · K23HL150311

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗