Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Graft survival
研究概览
简要总结
The use of steroids after kidney transplantation has been challenged because of variable adverse effects which may increase the patient morbidity and mortality. The aim of this study was to compare the safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients.
详细描述
131 patients were randomized to CsA (n = 63) or TAC (n = 68). Of 118 patients who did not have a biopsy-proven rejection episode and who had a serum creatinine level < 2.0 mg/dL 6 months after transplantation, 55 were of the CsA group and 63 were of the TAC group. We assessed patient and graft survival, acute rejection episodes, and adverse events 5 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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 15 years
- •first living donor kidney transplantation
排除标准
- •congestive heart failure (ejection fraction < 35%)
- •chronic liver disease
- •underlying diabetes mellitus
- •evidence of systemic infection at screening time
- •history of malignant disease
- •multiple organ transplantation
- •positive serologic evidence of human immunodeficiency virus
研究组 & 干预措施
cyclosporine
干预措施: cyclosporine (Drug)
Tacrolimus
干预措施: tacrolimus (Drug)
结局指标
主要结局
Graft survival
时间窗: 5 years
Patient survival
时间窗: 5 years
次要结局
- cumulative incidence of acute rejection(5 years)
- estimated glomerular filtration rate(5 year)
- new-onset diabetes mellitus(5 year)
- Hypertension(5 year)
- hyperlipidemia(5 year)