NCT00861536已完成4 期
An Open, Multicenter, Randomised, Parallel Group Pilot Study to Investigate Two Different Polyclonal Rabbit Immunoglobulin Preparations for Safety and Efficacy:A Comparison of ATG-Fresenius S to Thymoglobulin in Prophylaxis for Immunological High Risk Patients Following Renal Transplantation
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Recipients, who are at least 18 years or older and have a high immunological risk defined by:
- •The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are
- •For class I below the threshold of detection of a current CDC T-cell-/ and B-cell cross-match
- •For class II below the threshold of detection of a current CDC B-cell cross-match.
- •Patient receives a renal allograft only.
- •Female patients of child bearing age agree to maintain effective birth control practice during the study.
- •Patient has been fully informed and has given written or independent person witnessed oral informed consent.
排除标准
- •Patient is pregnant or breastfeeding.
- •Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
- •Patient and donor have a positive T-cell crossmatch.
- •Patient and donor are ABO incompatible.
- •Patient with combined transplantation.
- •Age of donor >75 years.
- •Cold ischemia time >40 hours.
- •Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
- •Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
- •Patient is allergic or intolerant to ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.
- •EBV risk constellation (recipient EBV negative and donor EBV positive).
- •Patient or donor is known to be HIV positive.
- •Patient has a liver disease, defined as continuously having ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3fold of the upper value of the normal range of the investigational site during the past 28 days.
- •Patient with malignancy or history of malignancy <2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- •Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
- •Patient is unlikely to comply with the visits schedule in the protocol.
研究组 & 干预措施
Thymoglobuline Genzyme
Active Comparator
干预措施: Thymoglobuline Genzyme (Drug)
ATG Fresenius
Experimental
干预措施: ATG Fresenius (Drug)
结局指标
主要结局
Adverse events
时间窗: Daily
次要结局
- Rejection(Daily)
- Patient survival(Daily)
- Graft function(Daily)
- Graft survival(Daily)
研究者
研究点 (1)
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