Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change in coronary artery calcification score
研究概览
简要总结
To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75 yr
- •Willingness to provide written informed consent
- •Ability to understand the study procedures
排除标准
- •Life expectancy < 3 months
- •Claustrophobia
- •Allergy to iodinated contrast
- •Treatment incompliance
- •Pregnancy
- •Highly HLA-sensitized patients
- •Severe dyslipidemia or proteinuria
- •Severe leucopenia or thrombocytopenia
- •GFR < 30 ml/min
研究组 & 干预措施
everolimus-based immunosuppression
immunosuppression with everolimus, prednisone and mycophenolate
干预措施: everolimus (Drug)
standard immunosuppression
immunosuppression with tacrolimus, prednisone and mycophenolate
干预措施: everolimus (Drug)
结局指标
主要结局
change in coronary artery calcification score
时间窗: 3 years
Comparison in a randomised way the effect of a calcineurin-based immunosuppressive regimen with an mTOR-based regimen on progression of coronary calcification on renal transplant patients. The results of this study will provide more insight in protection against cardiovascular disease in renal transplant patients.
次要结局
未报告次要终点
研究者
B.C. van Jaarsveld, MD PhD
MD, PhD
Dianet Dialysis Centers