A Prospective Randomized Controlled Study to Evaluate Feasibility and Safety of Early Steroid Withdrawal After 6mg/kg vs 4.5mg/kg Thymoglobulin Induction Therapy in Kidney Transplantation
试验速览
- 阶段
- 4 期
- 入组人数
- 154
- 主要终点
- A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
研究概览
简要总结
This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with renal failure from 18 to 70 years of age
- •Candidates for cadaveric or living donor kidney transplantation
- •Patients who are able and willing to consent the protocol of the study
排除标准
- •Patients who have been receiving immunosuppressive therapy before transplantation
- •Patients who have received an investigational medication within the past 30 days
- •Patients who have a known contraindication to the administration of antithymocyte globulin
- •Patients who are 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)
- •Patients who have had cancer (except non melanoma skin cancer) within the previous 2 years
- •Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives
研究组 & 干预措施
6.0ATG
Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy
干预措施: Thymoglobulin (Drug)
4.5ATG
Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
时间窗: 12 months after kidney transplantation
次要结局
- Overall rate of acute rejection(12 months after kidney transplantation)
- Pathologic findings according to Banff 2013 criteria(1 day at the time of biopsy)
- The rate of steroid-free immunosuppressive regimen(12 months after kidney transplantation)
研究者
Duck Jong Han
Professor
Asan Medical Center