A Prospective, Open-label, Controlled, Randomized Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After 90 to 150 Days After Kidney Transplantation in Adults, Maintaining Corticosteroid and Mycophenolate Sodium Compared to Patients Who Will Maintain the Use of Calcineurin Inhibitor
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in Creatinine Clearance at 24 months
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.
详细描述
The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 65 years old
- •First transplantation recipients
- •PRA < 30%
- •Living or cadaveric donor
- •Stable renal function
- •Patients not pregnant or breastfeeding , where pregnancy is defined as the woman status from conception to gestation conclusion, through a positive beta hCG test (>5mUI/mL)
- •Provided written informed consent form
排除标准
- •Cadaveric donor with expanded criterion
- •Multiple organs transplantation
- •Kidney cold ischemia time > 24 hours
- •Severe rejection episode - Banf >IIA
- •Glomerular filtration rate < 35mL/min
- •Presence of hard to treat dyslipidemia - severe hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>500mg/dL)
- •Proteinuria > 800mg/24h
- •Patients with history of malignancy of any organic system, treated or not, within 5 years, with or without evidence of local recurrence or metastases, other than localized basal cell carcinoma
- •Female with childbearing potential without using a reliable contraceptive method.
研究组 & 干预措施
Everolimus
干预措施: Everolimus (Drug)
calcineurin inhibitor
干预措施: calcineurin inhibitor (Drug)
结局指标
主要结局
Change from Baseline in Creatinine Clearance at 24 months
时间窗: baseline and two years
The primary objective is to demonstrate the effectiveness and non-inferiority of treatment with everolimus, by assessing renal function, in comparison with the use of calcineurin inhibitor.
次要结局
- Number of Participants with Adverse Events(baseline and two years)
研究者
Deise de Boni Monteiro de Carvalho
Organ Transplant Technical Manager
Hospital Federal de Bonsucesso