A Prospective Open Label Randomised Multicentre Study Evaluating the Efficacy & Safety of Rituximab Given Pre-Transplant to Sensitised Renal Allograft Recipients in Addition to a "Standard" Desensitisation Regimen Consisting of PE/IVIG & MMF
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- Biopsy proven antibody mediated rejection
研究概览
简要总结
About one third of prospective kidney transplant recipients have antibodies in their blood directed against the tissues of their only available kidney donor. Recently, "desensitisation" treatments when administered pre-transplant have allowed successful transplantation of these patients despite high rates of acute antibody mediated rejection (AAMR). The investigators propose to test in a randomised controlled trial whether rituximab, a monoclonal antibody that depletes B-lymphocytes, will safely lower antibody mediated rejection (AMR) rates when added to "standard" therapy. The investigators will also test whether rituximab enables more patients to achieve a negative crossmatch against their donor and thereby allow more transplants to proceed.
详细描述
This study is designed to investigate in a prospective, randomised fashion whether a single intravenous dose of rituximab (375 mg/m2) given two weeks prior to transplant, in addition to standard therapy, will allow sensitised renal transplant subjects to achieve a negative CDC crossmatch and thereby proceed to live donor transplantation. We will also evaluate whether rituximab will reduce the number of AAMR episodes in the post-transplant period, compared to controls. All eligible subjects must have a positive T- and/or B-cell CDC or flow cytometry crossmatch and have donor-specific antibodies identified by solid-phase assay at screening. All subjects will receive a standard desensitisation regimen that includes plasma exchange/IVIG + MMF before and immediately after transplantation followed by a standard care immunosuppressive regimen (IL-2R antagonist, tacrolimus, mycophenolate mofetil [MMF] and corticosteroids) after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Rituximab (Drug)
2
干预措施: Standard Care (Drug)
结局指标
主要结局
Biopsy proven antibody mediated rejection
时间窗: 12 months
次要结局
- Elimination of donor specific antibodies (DSA)(Day - 2 , 7; Months 1, 3, 6, 9 and 12)
- C4d in biopsies(Day 7; Months 3 and 12)
- Plasma exchanges(Month 12)
- Death(Month 12)
- Treated rejection(Month 12)
- Graft loss(Months 3, 6 and 12)
- Treatment failure(Months 6 and 12)
- Calculation of glomerular filtration rate (GFR)(Months 1 - 12)
- Slope of 1/serum creatinine (Ser. Cr)(Months 6 and 12)
- 24-hour U protein(Months 3 and 12)
- Safety(Month 12)
- Cancer and infections(Month 12)