Efficiency of Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil When Used in Combination With Tacrolimus and Prednisolone in Living Donor Kidney Transplantation
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of acute rejection
研究概览
简要总结
Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Because of the high cost of these medications we need to carefully evaluate the cost-effectiveness of each drug regimen, especially in low-middle income countries. The objective of this clinical trial is to compare the efficiency and cost of two immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus, mycophenolate mofetil and prednisolone.
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
- •Adult end-stage renal disease patients
- •First living donor kidney transplant.
- •Moderate immunological risk.
排除标准
- •Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).
- •High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).
- •Known hypersensitivity to any of the study medication.
研究组 & 干预措施
ATG
Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone
干预措施: Antithymocyte Immunoglobulin (Rabbit) (Drug)
BAS
Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone
干预措施: Interleukin 2 Receptor Antagonist (Drug)
结局指标
主要结局
Incidence of acute rejection
时间窗: 6 months post kidney transplant
The incidence of acute rejection will include clinically diagnosed and biopsy proven acute rejection. Clinically diagnosed rejection includes at least 30% acute rise in serum creatinine level. Biopsy proven rejection will include both cellular and antibody mediated rejection according to Banff 2017 criteria
One year graft survival
时间窗: 1 year post kidney transplant
One year kidney allograft survival, uncensored for patient death
次要结局
- Cost of immunosuppressive medication(1 year post kidney transplant+)
研究者
Sarra Elamin
Consultant Physician and Nephrologist
University of Khartoum