Immune Monitoring and Calcineurin Inhibitor (CNI) Withdrawal in Low Risk Recipients of Kidney Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 11
- 主要终点
- Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization
研究概览
简要总结
The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this research study will evaluate whether reducing immunosuppression can decrease some of these side effects while still preventing rejection of the kidney.
详细描述
Kidney transplantation is a treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients take immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. All anti-rejection medications have unwanted side effects. The purpose of this study is to evaluate the safety of slowly removing tacrolimus, a CNI.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tacrolimus (CNI) Withdrawal
Subjects randomized (2:1) to tacrolimus (CNI) withdrawal.
Recipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a standard immunosuppressive regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus.Subjects without any clinical acute rejection (AR) in the first 6 months, without borderline or acute rejection on the 6 month biopsy, and without donor-specific antibody (DSA) at anytime, including the 6 month test are randomized (2:1) to tacrolimus (CNI) withdrawal.
干预措施: Tacrolimus (CNI) Withdrawal (Drug)
Tacrolimus (CNI) Withdrawal
Subjects randomized (2:1) to tacrolimus (CNI) withdrawal.
Recipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a standard immunosuppressive regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus.Subjects without any clinical acute rejection (AR) in the first 6 months, without borderline or acute rejection on the 6 month biopsy, and without donor-specific antibody (DSA) at anytime, including the 6 month test are randomized (2:1) to tacrolimus (CNI) withdrawal.
干预措施: Standard Immunosuppressive Therapy (Drug)
Standard Immunosuppressive Therapy
Subjects randomized to standard immunosuppressive therapy, without subsequent tacrolimus (CNI) withdrawal.
Recipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a standard immunosuppressive regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus. Tacrolimus (CNI) withdrawal does not occur.
干预措施: Standard Immunosuppressive Therapy (Drug)
结局指标
主要结局
Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization
时间窗: IF/TA scores on protocol biopsies obtained at 24 months post-randomization will be compared to those obtained at the time of implantation for this measurement.
The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.
次要结局
- Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation(6 months post-transplantation, 24 months post-transplantation)
- Participant Survival Rate(6 to 18 months post-transplantation)
- Percentage of Participants With New Donor Specific Antibodies (DSAs)(6 to 18 months post-randomization)
- Incidence of Acute Rejection(6 to 18 months post-randomization)
- Allograft Survival Rate(6 to 18 months post-randomization)
- Percentage of Participants in the Experimental Arm Off Tacrolimus(18 months post-randomization)
- Incremental Change in IF/TA Scores(6 to 18 months post-transplant)
- Measurement of Urinary Parameters Before and After Randomization(6 months post-transplantation to 18 months post-randomization)
- Percentage of Participants With Donor-Specific Memory Using Elispot(6 to 18 months post-randomization)