Basiliximab vs Reduced Dose Rabbit Antithymocyte Globulin (rRTAG): Evaluation of Efficacy and Safety Outcomes in Low Immunological Risk Living Donor Kidney Transplant: 12-month Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Biopsy proven acute rejection
研究概览
简要总结
Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction
详细描述
Introduction
The TAILOR study in living donor kidney transplantation demonstrated a 98% one year patient and graft survival and 91% and 83% at 5 years with rejection-free patients in 93%. The cumulative dose of r ATG (thymoglobulin) was 5.29 mg / kg with 3% adverse effects and almost 50% steroid free at 12 months. Others have explored the benefit of low doses of r ATG (thymoglobulin) (3-5 mg / kg) against Basiliximab in low-risk population and demonstrated in living donor recipients with 8 year follow-up similar survival rates with a lower BPAR rate in rATG (thymoglobulin) (p <0.05) and better serum creatinine in 3 and 5 years. The aim of the study was to demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction.
Material and methods
Prospective randomized study of patients undergoing renal transplantation who wish to participate. 100 patients who meet the inclusion and exclusion criteria at the time of transplantation will be randomized
Experimental and reference therapy:
Group A: Induction with Basiliximab 20 mg IV day 0 and day 4 Group B: rATG (Thymoglobulin) 1 mg / kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg / kg day. According to protocol administration, if there are conditions to delay administration (WBC<2000 / mm3 and / or platelets <75,000 / mm3) (17), administration may be postponed until day 7 posttransplant Posttransplant immunosuppression: Tacrolimus, mycophenolate mofetil and steroids
Outcome measures (12 months) delayed graft function slow graft function biopsy proven acute rejection episodes infections hospitalizations adverse events graft loss death
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
- •Male or female graft recipients older than 18 years of age.
- •Informed consent to participate in the study.
- •First living donor kidney transplant recipient.
- •Negative pregnancy test if female participant
排除标准
- •Second or more kidney transplant.
- •Multiple organ transplant recipients.
- •ABO incompatibility or positive cross-over test prior to transplantation.
- •Antibody Reactive Panel (PRA) > 30%.
- •Positive specific donor antibodies (DSA).
- •Human immunodeficiency virus (HIV) positive patients.
- •HBsAg or HCV positive.
- •Severe lung disorders.
- •Severe allergies receiving treatment that prevent patient's rRTAG administration.
- •Leukocyte count below 2000 / mm
- •Platelet count below 75,000 / mm
- •History of malignant disease of any organ system (except skin basal cell carcinoma) within the last 5 years, regardless of local recurrence or metastasis.
研究组 & 干预措施
Group A (Basiliximab group)
Basiliximab (Simulect) induction therapy: 20 mg IV at day of transplant (to be administered 2 hours prior to transplant and up to 4 hours after transplant) and second dosage (20 mg) at fourth day after kidney transplantation.
干预措施: Basiliximab (Drug)
B (Low-dose Thymoglobulin group)
Thymoglobulin induction therapy (1 mg/kg rounded by 25 mg increments) at day of transplant followed by same dosage (1 mg/kg rounded by 25 mg increments) during day 1 and day 2 after transplant in order to complete 3 mg/kg accumulated dose.
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
Biopsy proven acute rejection
时间窗: 12 months following transplantation
Acute rejection described by Banff category
次要结局
- Patient survival(12 months following transplantation)
- Slow graft function(12 months following transplantation)
- Hospital admissions(12 months following transplantation)
- Graft function(12 months following transplantation)
- Graft loss(12 months following transplantation)
- Delayed graft function(12 months following transplantation)
- Infections(12 months following transplantation)