NCT01173107已完成4 期
A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- serum colchicine level
研究概览
简要总结
A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •from 18yrs to 80yrs , man and women
- •the patient who are taking colchicine
- •On screening, the patient shows that MDRD GFR >= 10 ml/min and <= 50 ml/min
- •the patient sign on the concent form
排除标准
- •the patient have experience to take medication that have an effect on renal function
- •At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP <= 100 mmHg or >=160 mmHg and DBP <=60 mmHg >=100 mmHg, or Heart rate < 40 beats/min or > 90 beats/min
- •pregnancy or anticipate pregnancy with 6 month
- •hypersensitivity to colchicine
- •acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
- •serum albumin < 3.5 mg/dL or > 5mg/dL
- •urinary retension, prostatic hyperplasia
- •the patient show gout attack on taking colchicine
- •the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
- •the patient who should take Atazanavir, Amprenavir, Apreptant, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil, cyclosporine, ranolazine
- •the patient who had taken part in the other study within 3months
- •the patient who had gotten blood transfusion
- •pregnant, breast feeding
研究组 & 干预措施
MDRD eGFR 10~50 ml/min/1.73m2
Experimental
干预措施: colchicine (Drug)
结局指标
主要结局
serum colchicine level
时间窗: 0,1,6 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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