NCT06584773招募中4 期
Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Occurrence of acute rejection and/or positive viremia for CMV
研究概览
简要总结
In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.
排除标准
- •Obese patients (body mass index above 35 m2);
- •History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure;
- •Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus;
- •Triglyceride levels greater than 300 mg/dl at enrollment;
- •Active infection by hepatitis B virus, hepatitis C virus or HIV;
- •CMV nonreactive IgG sorology at the time of transplantation.
研究组 & 干预措施
standard maintenance immunosuppression
Active Comparator
tacrolimus, mycophenolate and prednisone
干预措施: standard maintenance immunosuppression (Drug)
fourth maintenance immunosuppressive
Experimental
everolimus, tacrolimus, mycophenolate and prednisone
干预措施: Everolimus (Drug)
结局指标
主要结局
Occurrence of acute rejection and/or positive viremia for CMV
时间窗: From enrollment to the end of treatment at 52 weeks
First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients.
次要结局
未报告次要终点
研究者
研究点 (1)
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