Effectiveness and Safety of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy for Prevention of Graft Rejection Compared to Tacrolimus in Combination With MMF and Steroids in Cadaveric Kidney Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)
研究概览
简要总结
The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).
详细描述
Major advances in immunosuppressive therapy have resulted in long-term graft survival by the use of various drug combinations.However, these combinations carry the risk of e.g. infection, malignancy, renal damage, hypertension, diabetes, hyperlipidemia, hirsutism, cushingoid facial appearance and bone necrosis.Therefore one of the major goals should be to reduce immunosuppression without increasing risk of rejections.
Based on good results of a pilot study (not a single acute rejection episode during the 18-20 months observation period despite low level of Tacrolimus and absence of steroids) this randomised trial was designed to further evaluate the safety and efficacy of Campath-1H.
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
- •age 18-65
- •endstage renal failure with no previous renal transplantation
- •cadaveric donor
- •written informed consent
排除标准
- •pregnant or nursing women
- •multi-organ transplant recipients
- •live donor recipients
- •re-transplants
- •panel reactive antibodies (PRA) > 25%
- •previous treatment with Campath-1H
- •use of other investigational agents within 6 weeks
- •active systemic infection
- •HIV positive patient or donor
- •positive lymphocyte cytotoxicity cross-match between recipient serum and donor cells
- •past history of anaphylaxis following exposure to humanized monoclonal antibodies
研究组 & 干预措施
Campath-1H 20 mg
Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 20 mg IV infusion over 3-6 hours.
Day 1: Same protocol of Campath-1H and methylprednisolone as on Day 0.
Day 2: No treatment
Day 3: Initial dose of Tacrolimus 0,1 mg/kg/d (0,05 mg/kg/bid)
till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months).
Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.
干预措施: Alemtuzumab (Drug)
Tacrolimus
Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 30 mg IV infusion over 3-6 hours.
Day 1: No treatment
Day 2: Initial dose Tacrolimus 0.1 mg/kg/d (0.05 mg/kg.bid).
till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months).
Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.
干预措施: Tacrolimus (Drug)
Campath-1H 30 mg
Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 30 mg IV infusion over 3-6 hours.
Day 1: No treatment.
Day 2: Initial dose Tacrolimus 0.1 mg/kg/d (0.05 mg/kg.bid).
till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months).
Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.
干预措施: Alemtuzumab (Drug)
结局指标
主要结局
Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)
时间窗: Month 6
次要结局
- Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification)(Year 1)
- Time to 1st biopsy proven acute rejection episode (Banff Cl.)(Year 1)
- Patient and graft survival(Year 1)
- Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes(Year 1)
- Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection(Year 1)
- Adverse events (e.g. infections, PTLD)(Year 1)
- Creatinine clearance(Year 1)
研究者
Dr. Claudia Bösmüller
Dr. med.
Medical University Innsbruck