NCT01005121Unknown2 期
Colchicine for Diabetic Nephropathy
Prof.Avi Livneh1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 24 hr urine protein collection
研究概览
简要总结
Patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which their 24 hour urine protein and renal function tests will be monitored. The investigators' hypothesis is that colchicine will diminish proteinuria and might also help slow down the development of end stage renal failure in the long run.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with DM aging 18+, able to sign an informed consent.
- •24 hour protein collection between 0.5-6 mg during the last 6 months prior enrollment.
- •Hemoglobin A1c in the range of 6-9%, stable for the last year (0.5±)
- •Creatinine lower than 1.5 mg/dL.
- •Blood pressure lower than 150/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
- •Treated with ACE & ARB, unless contraindicated
- •Exclusion criteria:
- •Malignancy or significant heart, lung or liver disease.
- •Any GI disease, IBD, malnutrition ( BMI under 18 )
- •Psychiatric disease
- •Any muscle disease, history of rhabdomyelysis, myopathy or myositis.
- •Any disease causing renal injury/proteinuria apart from DM
- •Any inflammatory or autoimmune disease
- •Any infection during the last month.
- •Use of potentially nephrotoxic drugs.
- •Woman in child bearing age that do not use at least one contraceptive device.
- •Pregnant or lactating woman.
- •Participation in another study during the last 3 months.
- •Alcohol or drug abusers
- •Anyone whom the investigators conclude are not appropriate
- •Any patient receiving steroids.
- •Any patient with Colchicine allergy, or treated with the drug during the last two weeks.
排除标准
- 未提供
研究组 & 干预措施
colchicine
Experimental
patients will receive 2 mg of colchicine daily
干预措施: colchicine (Drug)
结局指标
主要结局
24 hr urine protein collection
时间窗: every 2 months
次要结局
未报告次要终点
研究者
Prof.Avi Livneh
Dept Head
Sheba Medical Center
研究点 (1)
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