Efficacy and Safety of Certican® in Combination With Myfortic® in Adult Renal Allograft Recipients Following Calcineurin Inhibitor Withdrawal at Week 16 Compared to Patients Who Are Maintained on Tacrolimus and Myfortic®
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glomerular Filtration Rate
研究概览
简要总结
The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic® plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate (cGFR) from baseline to month 12.
The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus corticosteroids.
Patients will be submitted to monthly GFR determination but, for group comparison, only the GFR measured at month 12 and month 24 of renal transplantation will be used.
详细描述
1.Forty patients will be selected at 16 weeks of renal transplantation with 20 patients allocated in each study arm. The allocation will be done randomly to provide similar epidemiological characteristics with respect to gender, age, renal function and co morbidities in the two groups. The informed consent will obtained after an interview involving the researcher and patient when the protocol will be explained.
1.1 Study protocol
Patients of renal transplant unit at the Sao Jose University Hospital who sign the inform consent and fulfill the inclusion/exclusion criteria will be enrolled in this study.
The main population will be low-risk kidney transplant recipients defined as follow: primary transplant, patients older than 18 years old and recipients of first kidney transplantation with living donor with PRA <10%, using tacrolimus, EC-MPS, and steroids as primary immunosuppression, without delayed graft function and with stable renal function 3 months after transplantation.
Patients who fulfill the inclusion criteria and agree to participate in this study will have the CNI withdrawn and the immunosuppressive regimen will be based on everolimus.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 18-70 years old
- •Receptors of a first living-donor kidney allograft
- •Patients must have been on a tacrolimus+myfortic regimen for at least 2 weeks prior to randomization
排除标准
- •Patients with evidence of any acute rejection following transplantation at the time of randomization
- •GFR ≤ 35 ml/min
- •Proteinuria > 800 mg/day
- •Recipients of multiple organ transplants
- •Chronic hepatic failure
- •Asymptomatic bacteriuria
- •Creatinine ≥ 2mg/dL on CNI withdrawn time
- •Proteinuria ≥ 1g/24h on CNI withdrawn time
- •Presence of uncontrolled hypercholesterolemia (≥ 350 mg/dL, ≥ 9.1 mmol/L)
- •Hypertriglyceridemia (≥ 500 mg/dL, ≥ 5.6 mmol/L)
研究组 & 干预措施
Certican, prednisona, EC-MPS
Twenty patients will be selected at 16 weeks of renal transplantation to convert a immunosuppression to certican,prednisone and myfortic. The allocation will be done randomly to provide similar epidemiological characteristics with respect to gender, age, renal function and co morbidities in the two groups. The informed consent will obtained after an interview involving the researcher and patient when the protocol will be explained.A protocol renal biopsy will be performed at the end of the study, 12 months after transplantation
干预措施: Certican (Drug)
结局指标
主要结局
Glomerular Filtration Rate
时间窗: 96 weeks
The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic® plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate (cGFR) from baseline to month 12.
次要结局
- Non-inferiority of biopsy-proved acute rejection (BPAR), graft loss, death(1 year after enrollment)