Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 6
- 主要终点
- Renal Function calculated using the 4 variable MDRD formula
研究概览
简要总结
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.
This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 18 years,
- •recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
- •patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
- •all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.
排除标准
- •patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,
- •patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
- •patients with previous history of malignancy,
- •patients with significant hematological or metabolic laboratorial abnormalities.
研究组 & 干预措施
Tacrolimus
Maintenance on tacrolimus
干预措施: Maintenance on tacrolimus (Drug)
Sirolimus
Conversion from Tacrolimus to Sirolimus
干预措施: Conversion from Tacrolimus to Sirolimus (Drug)
结局指标
主要结局
Renal Function calculated using the 4 variable MDRD formula
时间窗: 24 months
次要结局
- Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.(24 months)
- Incidence of all treated acute rejections.(24 months)
- Incidence and severity of all tBCAR.(24 months)
- Patient and graft survival.(24 months)
- Incidence of treatment discontinuation(24 months)
- Incidence of adverse events.(24 months)
研究者
Helio Tedesco Silva Junior
PhD
Hospital do Rim e Hipertensão