IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 主要终点
- Elimination of Donor Specific Antibodies
研究概览
简要总结
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
详细描述
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 years of age or older
- •diagnosed with end stage renal disease
- •currently receiving either hemodialysis or peritoneal dialysis
- •active on the kidney or kidney/pancreas transplant list
- •medical clearance of the kidney donor if live related transplant
- •elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list
排除标准
- •received IVIG within 6 months prior to enrollment
- •HIV positive
- •Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
- •Selective IgA deficiency or known antibodies to IgA
- •Allergy to human immune globulin
- •Pregnant or breast feeding
研究组 & 干预措施
Group 1 intravenous immune globulin
Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
干预措施: intravenous immune globulin (Drug)
Group 2 intravenous immune globulin
Intravenous immune globulin for patients who have living donors with positive crossmatch results.
干预措施: intravenous immune globulin (Drug)
结局指标
主要结局
Elimination of Donor Specific Antibodies
时间窗: 1 year
次要结局
- Negative B and T Cell Crossmatch(1year)