Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in de Novo Kidney Transplant Patients - a Multicenter, Randomized, Parallel Group Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
- 主要终点
- efficacy failure
研究概览
简要总结
To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.
详细描述
To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in de novo kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.
The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function) and renal function
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with end stage kidney disease who is a suitable candidate for primary kidney transplantation.
- •Patients scheduled to undergo renal allograft transplantation with compatible ABO blood type.
- •Peak PRA <50%
- •Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
- •Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
排除标准
- •Subject has previously received or is receiving an organ transplant other than kidney
- •Subject is receiving double-kidney transplant.
- •Subject is receiving an ABO incompatible or T-cells cross match positive transplant.
- •Cold ischemia time of allograft is > 24 hours before kidney transplantation surgery.
- •Subject is receiving organ from a Human Leukocyte Antibody (HLA) identical donor.
- •Known contraindication to administration of ATG-F, including:
- •Subject has known hypersensitivity to rabbit proteins
- •Subject with severe thrombocytopenia
- •Subject with bacterial, viral or mycotic infections which are not under therapeutically control
- •Subject has known hypersensitivity to tacrolimus, macrolide antibiotics, mycophenolate mofetil, or any of the product excipients.
- •Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of the investigator or has a history of non-compliance.
- •Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception during the study and for 6 weeks following completion of the study.
- •Patients with evidence of active liver disease (liver function tests ≥ 2 times upper limit of normal) or the presence of a chronic active hepatitis B or C.
- •Recipient or donor is seropositive for human immunodeficiency virus (HIV).
研究组 & 干预措施
ATG-F single dosing group
Intravenous (IV)
干预措施: ATG-F (Drug)
ATG-F continuous dosing group
Intravenous (IV)
干预措施: ATG-F (Drug)
结局指标
主要结局
efficacy failure
时间窗: 12 months post-transplant
Efficacy failure is defined as any of the following events: * patient's death, * graft loss, * acute rejection, * and/or lost to follow-up.
次要结局
- Incidence of DGF(6 and 12 months)
- incidence and severity of AEs(6 months and 12 months)
- Incidence of patient survival(6 and 12 months)
- Incidence of graft survival(6 and 12 months)
- Renal function: serum creatinine/eGFR(1, 3, 6 and 12 months)
- Incidence of acute rejection(6 and 12 months)