NCT04500665招募中2 期
Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Between-group change in left ventricular global longitudinal strain
研究概览
简要总结
This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
Colchicine
Experimental
Colchicine 0.3 mg once daily
干预措施: Colchicine (Drug)
结局指标
主要结局
Between-group change in left ventricular global longitudinal strain
时间窗: 4 weeks
Assessed using transthoracic echocardiography
次要结局
- Between-group change in left ventricular systolic and diastolic function(4 weeks)
- Between-group change in left ventricular size(4 weeks)
- Between-group change in left ventricular volumes(4 weeks)
- Between-group change in systemic inflammation(4 weeks)
研究者
Leo F. Buckley, PharmD
Clinical Pharmacy Specialist
Brigham and Women's Hospital
研究点 (1)
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