NCT03088280Unknown4 期
Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Acute rejection
研究概览
简要总结
Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Primary kidney transplant recipients, adults
排除标准
- •PRA > 50%
- •DSA > 1500 MFI
- •Retransplantation
- •Patients who are planning to receive mycophenolate instead of everolimus
- •Patients who have planning for follow-up in another center
研究组 & 干预措施
3mg/kg Group
Experimental
Patients will received Thymoglobuline 3mg/Kg (reduced dose)
干预措施: Thymoglobulin (Drug)
6mg/kg Group
Active Comparator
Patients will received Thymoglobuline 6mg/Kg (standard dose)
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
Acute rejection
时间窗: 1 year
Biopsy proven and all treated acute rejection episodes
次要结局
- Infection(1 year)
研究者
Tainá Veras de Sandes Freitas
MD PhD
Hospital Geral de Fortaleza
研究点 (1)
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