Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Efficacy compound outcome
研究概览
简要总结
Recipients from living donors kidneys HLA-identical were lower risk for acute rejection, graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen for this population.
Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated with chronic use of these agents. Moreover, the use of EVR is associated with increased incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing that proteinuria may be the first indication of recurrence of the underlying renal disease, detailed information about the patient's medical history and histological analysis of the graft may contribute with additional knowledge in this area.
The aim of this prospective, open, single arm study that will be performed only in the Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive regimen. This will include 100 recipients of first or second kidney transplant from a living donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a period of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult candidates of first or repeat kidney transplant HLA identical living donors;
- •Patient who signed the informed consent form to participate in this study;
排除标准
- •Patients were excluded if they had been receiving immunosuppressive therapy before transplantation;
- •Patients who received an investigational medication within the past 12 months;
- •Patients with suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
- •Patient who had had cancer (except nonmelanoma skin cancer) within the previous 2 years.
- •Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives were excluded.
研究组 & 干预措施
Everolimus
Single arm
干预措施: Everolimus (Drug)
结局指标
主要结局
Efficacy compound outcome
时间窗: 12 months
Incidence of treatment failure, defined as the first occurrence of biopsy confirmed acute rejection, graft loss, death, or treatment discontinuation.
次要结局
- acute rejection, allograft and patient survival.(12 months)
研究者
Helio Tedesco Silva Junior
PhD
Hospital do Rim e Hipertensão