Single Dose rATG for Treatment of Acute Renal Allograft Rejection
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hospital length of hospitalization (days)
研究概览
简要总结
Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter.Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration including correlation to length of hospital stay and hospital costs.
详细描述
Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter. This prolonged course is not consistent with the Medicare diagnosis-related group (DRG) for acute rejection which limits rejection admission to 3 days. The prolonged hospitalization results in increased medical costs and uniform financial loss to the hospital for patients admitted under this DRG. In addition there is a patient related toll of the prolonged hospitalization and a potential for additional hospital acquired complications. Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. The investigators hypothesize that single-dose rATG infusion will be as safe and efficacious as standard rATG administration when used for rejection treatment and would result in significant reduction in the length of hospital stay (LOS) and hospital costs for rejection treatment.
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
- •Male or female subjects aged 18 years or older
- •Experiencing a biopsy-proven acute rejection episode which:
- •will require the use of rATG based on severity, or
- •is exhibiting resistance to corticosteroid treatment, defined as failure of the serum creatinine to decrease after at least 3 days of corticosteroid treatment (≥200 mg/day of methylprednisolone or equivalent)
排除标准
- •Patients with known severe allergy to antithymocyte globulin or rabbits
- •Rejection episode requiring the use of therapeutic plasma exchange immediately subsequent to rATG administration
- •Currently receiving any investigational drug or treatments
研究组 & 干预措施
Standard dose rATG
Standard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days
干预措施: rATG (Drug)
Single dose rATG
Single dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration
干预措施: rATG (Drug)
结局指标
主要结局
Hospital length of hospitalization (days)
时间窗: 7 days
The length of hospitalization for treatment of renal allograft rejection in days will be determined which should be an average of 5-7 days
次要结局
- Infusion related symptoms(7 days)
研究者
Samir J. Patel
Clinical Pharmacist
The Methodist Hospital Research Institute