Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence in Kidney Transplant Recipients (StopCMV: S=Sirolimus CMV= Cytomegalovirus)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Cytomegalovirus infection/disease recurrence
研究概览
简要总结
Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence.
Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence.
Given this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.
详细描述
This protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) Maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). Our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult kidney transplant recipients > 18 y.o.
- •Kidney Transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone.
排除标准
- •Re-transplant;
- •Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II;
- •Acute rejection episode in the last 30 days, or episode > 2A in the Banff criteria;
- •GFR (MDRD) < 40 ml/min;
- •Proteinuria > 0,5 g/l;
- •Hemoglobin < 10 g/l and/or leucocytes < 4000 cels/mm3 and/or platelets < 150.000 cels/mm3;
- •Triglycerides > 500 mg/dl with or without use of fibrate;
- •Cholesterol total > 300 mg/dl with or without use of statin;
- •Hepatic abnormalities;
- •Significant periphery edema;
- •Pulmonary abnormalities or breast x-ray abnormalities;
- •Hyper sensibility to sirolimus formula;
研究组 & 干预措施
Drug conversion to sirolimus
Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.
干预措施: Drug conversion to sirolimus (Drug)
Maintenance of the current regimen
Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.
干预措施: Maintenance of the current regimen (Drug)
结局指标
主要结局
Cytomegalovirus infection/disease recurrence
时间窗: One year
Cytomegalovirus infection/disease recurrence
次要结局
未报告次要终点
研究者
Geovana Basso
MD
Hospital do Rim e Hipertensão