An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Evaluate cumulative patient and graft survival at 12 months post conversion
研究概览
简要总结
The study hypotheses to be tested in this study are:
- Conversion to everolimus at 3 months post-transplantation is safe and effective;
- Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;
- Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing their first living- or deceased-donor kidney transplant who maintain a functioning graft 3 months post-transplant;
- •Older than 18 years;
- •Panel-reactive antibodies lower than 20%;
- •Baseline immunosuppression with tacrolimus, mycophenolate sodium (MPS) and prednisone at randomization at 3 months.
排除标准
- •eGFR < 35 mL/min at randomization;
- •Urine protein-to-creatinine ratio > 0.8 at randomization;
- •Episode of acute rejection with Banff histological classification > 1A in the first 3 months post-transplant;
- •Cholesterol > 350 mg/dL or triglycerides > 400 mg/dL with therapy at randomization;
- •Active infection at randomization;
- •Chronic liver disease;
- •Refusal to participate in the study;
- •Contraindications to kidney biopsy;
- •Biopsy findings at 3 months post-transplant including borderline rejection, cellular rejection or antibody-mediated rejection.
研究组 & 干预措施
Tacrolimus
The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy.
Intervention arm: Tacrolimus
干预措施: Tacrolimus (Drug)
Everolimus
The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy.
Intervention arm: Everolimus
干预措施: Everolimus (Drug)
结局指标
主要结局
Evaluate cumulative patient and graft survival at 12 months post conversion
时间窗: one year
Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis
次要结局
- Evaluation of estimated glomerular filtration rate 12 months post-conversion(one year)