NCT05362474终止3 期
Targeting Leukotrienes in Kidney Disease: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Albuminuria at 3 Months
研究概览
简要总结
Diabetic kidney disease (DKD) is associated with significant morbidity and mortality. Identifying new treatments for DKD to be used alone or in combination with other therapies is a high priority. Inflammation plays a key role in DKD and targeting pro-inflammatory lipid mediators called leukotrienes may represent a promising therapy for DKD. The current proposal will investigate whether montelukast, a leukotriene antagonist, reduces proteinuria and improves vascular function and arterial stiffness in patients with DKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD stage 3
- •urine albumin to creatinine ratio 200-5000 mg/g
- •blood pressure <140/90 mmHg
- •use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
- •history of diabetes type 1 or 2
- •BMI <40 kg/m2
- •Stable antihypertensive regimen for at least one month prior to enrollment
- •Stable diabetes regimen for at least one month prior to enrollment
- •Sedentary or recreationally active (<2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)
- •Able to provide consent
排除标准
- •Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- •Uncontrolled hypertension
- •Factors judged to limit adherence to interventions (e.g. history of medication noncompliance, noncompliance with follow up visits, significant cognitive impairment, etc.)
- •Anticipated initiation of dialysis or kidney transplantation within 3 months
- •Current participation in another research study
- •Pregnancy or planning to become pregnant or currently breastfeeding
- •Allergy to aspirin
- •Severe hepatic impairment (Child-Pugh Class C)
- •History of major psychiatric disorder
- •Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)
- •Current use of SGLT2 inhibitor
- •Current use of phenobarbital, rifampin or carbamazepine.
研究组 & 干预措施
montelukast
Experimental
montelukast 10mg orally once a day
干预措施: Montelukast (Drug)
结局指标
主要结局
Change in Albuminuria at 3 Months
时间窗: Baseline, 3 months
Change in 24-hour urine albumin excretion at 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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