NCT00353535已完成1 期
Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant
研究概览
简要总结
The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft
详细描述
Focal and segmental glomerulosclerosis (FSGS) is resistant to treatment with immunosuppressants and after transplant, 40% of such patients have recurrences in renal allograft. The purpose of this trial was to use Total Lymphoid Irradiation (TLI) plus mycophenolate mofetil (MMF), cyclosporine A (CsA) and prednisone (PRED) to prevent recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients (age > 18 years)
- •Biopsy-proven primary FSGS
- •End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS.
- •Signed the informed consent before entering in the study.
排除标准
- •Age < or equal 18 years
- •No biopsy-proven FSGS
- •Without living donor to perform the transplant
- •No signed the informed consent
结局指标
主要结局
Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant
次要结局
- Morbidity and mortality ot the treatment
研究者
研究点 (2)
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