Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,209
- 试验地点
- 1
- 主要终点
- Incidence of Cytomegalovirus Infection or Disease
研究概览
简要总结
This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.
The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.
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
- •Recipients, adults of the first living or deceased donor kidney transplant;
- •Patients who agreed to participate in the study and signed the informed consent form
排除标准
- •Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;
- •Receptors with poor understanding about chronic kidney disease and its treatment alternatives;
- •Receptors with early history of non compliance to treatment with immunosuppressive drugs;
- •Retransplantation;
- •Multi-organ recipients;
- •Recipients with BMI> 30 kg / m2;
- •KDPI> 80%;
- •Cold ischemia time greater than 24 hours;
- •Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;
- •Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).
- •Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;
- •Patients with severe uncontrolled dyslipidemia;
- •Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;
研究组 & 干预措施
sirolimus +tacrolimus
Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL.
干预措施: Sirolimus (Drug)
everolimus +tacrolimus
Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL.
干预措施: Everolimus (Drug)
mycophenolate +tacrolimus
Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID).
干预措施: Mycophenolic acid (Drug)
结局指标
主要结局
Incidence of Cytomegalovirus Infection or Disease
时间窗: 12 months follow up
Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).
次要结局
未报告次要终点
研究者
Helio Tedesco Silva Junior
Principal Investigator
Hospital do Rim e Hipertensão