A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Subject and renal allograft survival
研究概览
简要总结
This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.
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
- •Have signed the informed consent form and the HIPAA patient information form (United States only)
- •Are ≥ 18 years of age
- •Are a transplant recipient of at least one HLA-mismatch kidney
- •For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method
排除标准
- •Have a history of previous renal transplant
- •Have had a PRA > 25% at any time
- •Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
- •Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
- •Have had previous treatment with efalizumab
- •Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer
- •Have a known contraindication to efalizumab
- •Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies
- •Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab
- •Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate
研究组 & 干预措施
1
干预措施: basiliximab (Drug)
1
干预措施: efalizumab (Drug)
1
干预措施: mycophenolate mofetil (Drug)
1
干预措施: corticosteroids (Drug)
2
干预措施: basiliximab (Drug)
2
干预措施: mycophenolate mofetil (Drug)
2
干预措施: corticosteroids (Drug)
2
干预措施: cyclosporine (Drug)
结局指标
主要结局
Subject and renal allograft survival
时间窗: 52 weeks
次要结局
- Change in metabolic/cardiovascular risk factors(24 weeks and 52 weeks)
- Glomerular filtration rate(12 and 52 weeks)
- Change in glomerular filtration rate(12 weeks to 52 weeks)
- Transplant renal biopsies(52 weeks)