A Randomized Clinical Trial of Efficacy and Safety on the Use of Belatacept as Compared to Tacrolimus in the Setting of Rabbit Antithymocyte Globulin Induction and Rapid Steroid Discontinuation in Deceased Donor Renal Transplant Recipients With a Focus on Ameliorating Delayed Graft Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of Participants With Delayed Graft Function (DGF)
研究概览
简要总结
The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.
详细描述
New York Presbyterian Hospital-Columbia University Medical Center (NYPH-CUMC) performs nearly 250 renal transplants annually; of these approximately half are recipients of a variety of deceased donor kidneys, usually with cold ischemia time (CIT) >24 hours leading to an approximate incidence of delayed graft function (DGF) of 50%. The main focus of this study will be to determine whether initial immunosuppression with belatacept with Thymoglobulin induction will result in lower incidence and/or more rapid disappearance of DGF than that observed in patients who receive tacrolimus based immunosuppression. NGAL determinations will bne made in the first months after transplantation to correlate with clinical DGF.
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
- •Patients must have known Epstein-Barr virus (EBV) serostatus, and that status must be positive
- •Adult patients ≥18 years of age, receiving a deceased donor kidney transplant at Columbia University Medical Center (CUMC)
- •Patients with a PRA ≤ of 50
- •Primary or re-transplant candidates (no more than 5th renal transplant)
- •Deceased donor renal transplant recipients
- •Candidates eligible for rATG induction
- •Patients fully consented prior to transplantation
- •Women of reproductive age who are willing to delay pregnancy for the duration of the study and use appropriate recommended contraception
排除标准
- •Seronegative or unknown EBV serologic status (due to the risk of post-transplant lymphoproliferative disorder, PTLD), predominantly involving the central nervous system.
- •Patients with tuberculosis who have not been treated for latent infection.
- •Scheduled to undergo multi-organ transplantation
- •Recipients of previous non-renal organ transplant
- •Patient receiving 5th renal transplant at the time of screening.
- •Patients with a PRA > 50
- •Recipient is pre-emptive status.
- •Recipient with positive flow crossmatch.
- •History or known HIV
- •Known hypersensitivity or contra-indications to Belatacept, Tacrolimus, Mycophenolate mofetil (cellcept), or mycophenolic acid
- •Use of an investigational drug in the past 30 days before day of surgery
- •Enrolled in a clinical trial other than the current
- •Lactating or pregnant women
- •Donor specific antibodies (DSA) identified at the time of transplantation
- •ABO incompatible renal transplant
研究组 & 干预措施
Belatacept Immunosuppression
Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Belatacept (Drug)
Belatacept Immunosuppression
Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Mycophenolate (Drug)
Belatacept Immunosuppression
Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: rATG (Drug)
Belatacept Immunosuppression
Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Methylprednisolone (Drug)
Belatacept Immunosuppression
Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Renal transplant (Procedure)
Standard Immunosuppression (Tacrolimus)
Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Tacrolimus (Drug)
Standard Immunosuppression (Tacrolimus)
Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Mycophenolate (Drug)
Standard Immunosuppression (Tacrolimus)
Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: rATG (Drug)
Standard Immunosuppression (Tacrolimus)
Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Methylprednisolone (Drug)
Standard Immunosuppression (Tacrolimus)
Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
干预措施: Renal transplant (Procedure)
结局指标
主要结局
Number of Participants With Delayed Graft Function (DGF)
时间窗: Up to 3 months post-transplantation
To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen. Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases \<10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF.
次要结局
- Estimated Glomerular Filtration Rate (eGFR)(Up to 1 year post-transplantation)
- Percentage of Participants With Allograft Survival(Up to 1 year post-transplantation)
- Number of Participants With an Allograft Rejection Episode(Up to 1 year post-transplantation)
研究者
Mark A Hardy
Auchincloss Professor of Surgery
Columbia University