Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor
研究概览
简要总结
The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:
- Immunological Testing
- Transplant Nephrectomy
- Pharmacologic Therapy
- Plasmapheresis
- Transplant
详细描述
Patients with high level of preformed antibodies (panel reactive antibodies [PRA]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Renal transplant recipients with a potential living donor who is incompatible (T-&/or B-cell locus) due to recipient high PRA or MHC antibodies
- •PRA greater than or equal to 20% within last twelve months
- •Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal Transplant Committee
排除标准
- •Patients with known allergy to CytoGam(R), Cellcept, Rapamycin
- •Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process
- •ABO incompatibility
- •Patients not capable of following through the treatment for various reasons as determined by treating physicians
- •Any potential recipient who is pregnant or becomes pregnant
- •Exclusion for Plasmapheresis: known allergy to ethylene oxide or natural rubber latex.
- •Exclusion for Plasmapheresis: Intake of ACE-inhibitor or Angtiotensiin-receptor blockers in the last 24 hours prior to plasma exchange
研究组 & 干预措施
CMVIG followed by PP
MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
干预措施: CMVIG (Drug)
结局指标
主要结局
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor
时间窗: four weeks
The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.
次要结局
- Monitor Graft Survival(5 years)
- Monitor Patient Survival(5 years)