Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Обзор

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

Вмешательства

• Препарат Colchicine
  Colchicine
• Препарат Placebo
  Placebo

Первичные конечные точки

• Between-group change in left ventricular global longitudinal strain [Срок оценки: 4 weeks]

Вторичные конечные точки (4)

• Between-group change in left ventricular systolic and diastolic function [Срок оценки: 4 weeks]
• Between-group change in left ventricular volumes [Срок оценки: 4 weeks]
• Between-group change in left ventricular size [Срок оценки: 4 weeks]
• Between-group change in systemic inflammation [Срок оценки: 4 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT04500665 · 2020P002468 · K23HL150311

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗