Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Time to recover from Delayed Graft Function
研究概览
简要总结
Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.
详细描述
Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Written Informed Consent
- •Deceased donor renal transplant recipient
- •Men and women, aged 18-60 years of age
排除标准
- •Seronegative or unknown EBV serostatus
- •Patients unwilling or incapable of providing informed consent.
- •Patients with active tuberculosis or positive TB test without evidence of infection treatment.
- •Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment
- •Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
- •Inadequate vein access to receive monthly IV infusions
- •Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
- •Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
- •Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©) are not permitted in this protocol; Use of other immunosuppressive agents must be limited to those specified in this protocol.
- •Prisoners or subjects who are involuntarily incarcerated.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- •Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II
研究组 & 干预措施
Belatacept
Belatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study.
干预措施: Belatacept (Drug)
Everolimus
Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.
干预措施: Everolimus (Drug)
结局指标
主要结局
Time to recover from Delayed Graft Function
时间窗: 2 weeks
For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks).
次要结局
- Percent patients reaching recovery (defined above) by 14 days and 3 months.(Assessed at 3, 6, 12 months)
- Biopsy proven acute rejection events(Assessed at 3, 6, 12 months)
- Patient and graft survival(Assessed at 3, 6, 12 months)
- Number of hospital readmissions(Assessed at 3, 6, 12 months)
- Hospital length of stay (days) from date of transplant to discharge(up to 7 days)
- Number of dialysis treatments(Assessed at 3, 6, 12 months)
- Number of biopsies(Assessed at 3, 6, 12 months)
- Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).(Assessed at 3, 6, 12 months)
- Incidence and type of infection(Assessed at 3, 6, 12 months)
- Detection of DSA (Luminex)(Assessed at 3, 6, 12 months)
- Measured or estimated creatinine clearance.(Assessed at 3, 6, 12 months)
- Banff score of rejection episodes and immune suppression treatment/management of rejection(Assessed at 3, 6, 12 months)