Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse event
研究概览
简要总结
A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.
详细描述
Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction regimen using Grafalon compared with ATG in de novo simultaneous pancreas 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), pancreas 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with end-stage,diabetic nephropathy(type1or 2)
- •Patients scheduled to undergo SPK 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.
- •Patient must have signed the Patient Informed Consent Form.
- •Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
排除标准
- •Patient is pregnant or breastfeeding.
- •Patient has a positive T-cell crossmatch on the most recent serum specimen.
- •Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- •Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- •Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
- •Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
- •Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
- •Donor is older than 55 years of age
- •patients with bacterial, viral or mycotic infections which are not under therapeutically control
研究组 & 干预措施
Anti-Tlymphocyte Globulins
intravenous，2mg/kg/d，for 5 days
干预措施: Anti-Tlymphocyte Globulins (Drug)
Anti-thymocyte Globulins
intravenous，1.5mg/kg/d，for 4 days
干预措施: Anti-Thymocyte Globulins (Drug)
结局指标
主要结局
Incidence and severity of adverse event
时间窗: up to 3 months post-transplantation
Incidence of patient's death,graft loss,acute rejection
次要结局
未报告次要终点
研究者
Yingxin FU.MD
Head of Department
Tianjin First Central Hospital