NCT00284947已完成4 期
REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
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
- Novartis
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels
研究概览
简要总结
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
- •Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
- •Patients who are able to tolerate full dose MPA.
- •Patients with glomerular filtration rate (GFR) > 30 mL/min.
- •Patients without an acute rejection episode during the preceding 6 months.
- •Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.
排除标准
- •Patients with preformed positive skin test against basiliximab
- •Patients with preformed panel reactive antibody (PRA) > 10%.
- •Signs of active immune process on graft biopsy.
- •Patients with multi-organ or second kidney transplant
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Maintenance immunosuppression
Experimental
40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)
- 1g MMF or 720mg EC-MPS p.o twice daily
- Oral corticosteroids
干预措施: basiliximab (Drug)
Maintenance immunosuppression
Experimental
40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)
- 1g MMF or 720mg EC-MPS p.o twice daily
- Oral corticosteroids
干预措施: MMF/EC-MPS (Drug)
Maintenance immunosuppression
Experimental
40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)
- 1g MMF or 720mg EC-MPS p.o twice daily
- Oral corticosteroids
干预措施: Corticosteroids (Drug)
结局指标
主要结局
to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels
时间窗: 6 months
次要结局
- to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect(24 weeks)
- to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs(6 month)
- to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs(6 months)
- to assess the changes in renal parameters after CNI discontinuation(Month 1-6 post trasnplant)
- to evaluate the risk of sensitization against the chimeric antibody over 6 months(6 months)
研究者
研究点 (1)
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