NCT00189735已完成2 期
A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 37
- 主要终点
- Incidence of biopsy-proven acute rejection over the first 24 weeks.
研究概览
简要总结
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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 has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).
- •Patient has been fully informed.
排除标准
- •Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.
- •Patient has significant liver disease.
- •Cold ischemia time of the donor kidney >28 hours.
- •Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- •Patient has previously received or is receiving an organ transplant other than kidney.
结局指标
主要结局
Incidence of biopsy-proven acute rejection over the first 24 weeks.
次要结局
- Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
- Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
- Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
- Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
- Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
- Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
- Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
- Incidence of adverse events
- Routine safety laboratory parameters
- Haemoglobin values at weeks two to six
- Safety first 24 weeks: Patient survival
- Graft survival
- Leukocytes at weeks two to six
- Thrombocytes at weeks two to six
- Bilirubin at weeks two to six
- Incidence of CMV viraemia
- Incidence of Diarrhoea, Gastroenteritis and Gastritis
- Safety after 1 year:Incidence of adverse events
- Patient and graft survival
研究者
研究点 (37)
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