NCT00549692已完成3 期
Minimization, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA Nephropathy
Kuhnil Pharmaceutical Co., Ltd.5 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 5
- 主要终点
- The rate of number of patients that 50% or more increase in SCr after 42 months
研究概览
简要总结
The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in retardation of increase of serum creatinine(SCr) in IgA Nephropathy
详细描述
In the current clinical study, attempts are made to assess the safety and efficacy of omega-3 fatty acids by comparing between omega-3 fatty acids and the placebo in Korean patients with IgA nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of both sexes age 18 or above
- •Biopsy-proven IgA nephropathy
- •Baseline serum creatinine ≥ 1.2mg/dl(Female),≥ 1.4mg/dl(Male)
- •Able to give written informed consent
排除标准
- •Hypertension SBP>160mmHg and/or DBP>100mmHg
- •Subject, who in the investigator's opinion, has a systemic disease that would contraindicate participation in this study
- •Use of omega-3 fatty acids or analog supplement
- •Pregnancy or breast feeding at time of entry or unwillingness to comply with measures for contraception
- •Current or recent (within 30 days) exposure to any investigational drug
- •Subject who has hypersensitivity to this agent as a previous illness
- •Low platelet(<100,000/㎕) or the subject who has a high risk of bleeding
- •Use of corticosteroid during the treatment period or less than 3 months prior to the screening
- •Use of anticoagulant during the treatment period or within 1 month or 6 half lives prior to screening
- •Subject who in the investigator's opinion, would be confronted with a difficulty
研究组 & 干预措施
Omacor
Experimental
干预措施: Omega-3 fatty acid ethylester90 (Drug)
Placebo Omacor
Placebo Comparator
干预措施: Omega-3 fatty acid ethylester90 (Drug)
结局指标
主要结局
The rate of number of patients that 50% or more increase in SCr after 42 months
时间窗: 42 months
次要结局
- The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months(42 months)
- Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile(42 months)
研究者
研究点 (5)
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