A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation
研究概览
简要总结
This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.
详细描述
The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota
排除标准
- •Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
- •Pediatric patients (<18 years of age)
- •Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
- •ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
- •Patients with severe hyperlipidemia (serum cholesterol >350 mg/dl or serum triglycerides >500 mg/dl
- •Patients with severe leukopenia (White Blood Cell count [WBC]<3000 10^3/ml)
- •Patients unwilling to return to the transplant center for late follow-up visits
- •Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon
研究组 & 干预措施
Tacrolimus
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
干预措施: Anti-thymocyte globulin (Drug)
Tacrolimus
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
干预措施: Mycophenolate mofetil (Drug)
Tacrolimus
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
干预措施: Prednisone (Drug)
Tacrolimus
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
干预措施: Tacrolimus (Drug)
Sirolimus
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
干预措施: Anti-thymocyte globulin (Drug)
Sirolimus
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
干预措施: Mycophenolate mofetil (Drug)
Sirolimus
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
干预措施: Prednisone (Drug)
Sirolimus
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
干预措施: Sirolimus (Drug)
结局指标
主要结局
Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation
时间窗: 12 months following transplantation
Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
次要结局
- GFR (iothalamate clearance) at other time points(24 months)
- Other measures of renal function (serum creatinine, proteinuria and albuminuria)(24 months)
- Acute rejection both early and after tacrolimus withdrawal(24 months)
- Patient and graft survival(24 months after transplantation)
- Complications-especially hypertension, diabetes, dyslipidemia(24 months)