Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Incidence of CMV disease
研究概览
简要总结
The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (> 18 years) candidates to renal transplant with expanded criteria deceased donors;
- •Low risk of acute rejection, defined as first kidney transplant recipients and Panel Reactive Antibody (PRA) <50%.
- •Signature of the informed consent form (ICF)
排除标准
- •Patients receiving immunosuppressive therapy before transplantation;
- •Patients who have received an investigational drug within last 30 days;
- •Patients with a known contraindication to the administration of an anti-thymocyte globulin;
- •Patients with a positive test for human immunodeficiency virus (HIV);
- •Patients who had cancer (except non-melanoma skin cancer) within last two years;
- •Pregnant women, breastfeeding women, and women of childbearing potential unwilling to use condoms or oral contraceptives will be excluded;
- •Patients with any Panel Reactive Antibody (PRA) equal to or higher than 50%, class I or class II, will also be excluded;
- •Patients with positive test for parasites (protozoa and helminths).
研究组 & 干预措施
Mycophenolate sodium
Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus
干预措施: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus (Drug)
Everolimus
Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus.
干预措施: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus (Drug)
结局指标
主要结局
Incidence of CMV disease
时间窗: 1 year
Incidence of CMV disease or infection during the first year of transplantation.
次要结局
- incidence of treatment failure(1 year)
研究者
Helio Tedesco Silva Junior
PhD
Hospital do Rim e Hipertensão