A Randomized, Open, Controlled Trial of High Dose IVIG/Rituximab Versus Rituximab in Kidney Transplant Patients With de Novo Donor-specific Antibodies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- change in delta DSA MFI sum
研究概览
简要总结
The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.
详细描述
Although recent advances in immunosuppressive regimens after kidney transplantation (KT) have reduced the incidence and consequences of T-cell-mediated rejection (TCMR) and have improved short-term outcomes, long-term allograft loss attributable to AMR is still responsible for substantial medical and socioeconomic burdens in kidney transplant recipients. Numerous studies have shown that de novo DSA after KT are associated with AMR, which leads to allograft loss. IVIG is a medication that has emerged as a useful tool in modulating immunity, treatment of AMR and in desensitization protocol. Treatment with rituximab or combination of IVIG/rituximab has sought to further diminish antibody production (de novo DSA) in the treatment of AMR. Several studies have been reported, but in the absence of control groups or standardization of treatment, their efficacy is difficult to assess.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following
- •age ≥ 19 years
- •Renal transplants with eGFR ≥ 20 ml/min (by CKD-EPI equation) and change in the eGFR ≤ 20 within 3 months
- •No history of biopsy proven acute T cell mediated rejection or antibody-mediated rejection within 3 months
- •peak MFI of de novo DSA (DR or DQ) ≥ 1000
- •A patient who agree to write a written consent form
排除标准
- •age ≤ 18 years
- •multi-organ transplantation
- •Patients with no history of tacrolimus as immunosuppressants
- •history of allergic or anaphylactic reaction to rituximab
- •human immunodeficiency virus infection
- •active infection
- •pregnancy or lactation
- •history of drug abuse or alcohol abuse within 6 months
- •history of malignancy within 5 years
- •history of treatment for psychiatric problems
- •hematologic or biochemical abnormalities (Hb < 7g/dL, Platelet < 1x105/mm3, AST/ALT > 80IU)
- •A patient who do not want to participate in this study
研究组 & 干预措施
Rituximab
Inj Rituximab 375mg/m2 IV given on day 0
干预措施: Rituximab (Drug)
Combination of high-dose IVIG and Rituximab
IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0
干预措施: Rituximab (Drug)
Combination of high-dose IVIG and Rituximab
IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0
干预措施: intravenous immune globulin (Drug)
结局指标
主要结局
change in delta DSA MFI sum
时间窗: baseline and 3 months post-treatment, 1 year post-treatment
change of pre- and post-treatment DSA MFI sum, monitoring DSA during follow-up period
次要结局
- Change in estimated glomerular filtration rate(eGFR) by CKD-EPI equation(baseline and 3 months post-treatment, 1 year post-treatment)
- Development of antibody-mediated rejection (AMR)(up to 1 year post-treatment)