NCT00223041终止2 期
Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin
University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
研究概览
简要总结
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.
详细描述
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (18 - 65, inclusive)
- •cadaver and living kidney transplantation (
- •LDL-cholesterol ≤ 130mg/dl (-3 Mo until start of Tx)
- •Patients with a history of Myocard infarct: LDL-Cholesterol ≤ 110mg/dl
- •Immunsuppression: Tacrolimus in combination with steroids or Mycophenolat Mofetil
- •patients indulgence
排除标准
- •statin before the study
- •LDL-Cholesterol >130mg/dl before transplantation
- •Instabil Angina, Myocard infarct <6 months before transplantation
- •symptomatic Hypothyreosis
- •child bearing, lactating
- •elavated liver encymes (> 2x elavated: AST, ALT, bilirubine, PCK)
- •Fibrates are not allowed
- •multiorgantransplantation
研究组 & 干预措施
B
Placebo Comparator
no therapy with fluvastatin
干预措施: Fluvastatin (Drug)
结局指标
主要结局
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
时间窗: during the study
次要结局
- patients and kidney survival(during the study)
- amount and typ of rejection (Banff-classifikation)(during the study)
- change in lipids(during the study)
- adverse events of the statin fluvastatin(during the study)
研究者
研究点 (1)
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