Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression of left ventricular hypertrophy
研究概览
简要总结
This is a prospective, open label, single-center study, in kidney transplant recipients with stable renal function for 12 and 120 months after transplantation, that are in use use of calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular hypertrophy will be investigated before and after conversion of azathioprine to everolimus.
This study will evaluate as primary objectives: the prevalence of left ventricular mass hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability of everolimus to reduce left ventricular mass after conversion from Azathioprine, using sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR) at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years (black and white subjects);
- •Kidney transplant recipients of living donor or deceased with creatinine clearance (measured / estimated) > 50 ml /L for at least 12 months, receiving azathioprine with or without calcineurin inhibitor with or without prednisone.
排除标准
- •The subject, in the opinion of the investigator, is not able to complete the study protocol;
- •Multiple organ transplant recipient;
- •Pregnant women
- •Breastfeeding and childbearing age without contraceptive method
- •Test for Positive immunodeficiency virus (HIV)
- •Treatment of acute rejection in the last 3 months
- •Glomerulonephritis new relapse
- •New or polyomavirus nephropathy
- •protein / creatinine ≤ 150 mg / mmol or 24h proteinuria> 500mg
研究组 & 干预措施
LVH everolimus
Progression of left ventricular hypertrophy in recipients of kidney transplant after conversion of immunossupression from azathioprine to everolimus.
干预措施: Everolimus (Drug)
结局指标
主要结局
Progression of left ventricular hypertrophy
时间窗: 12 months
Progression of left ventricular hypertrophy will be mesure by MIR and echocardiography (systolic and end-diastolic diameter of the left ventricle, interventricular septum thickness in end diastole, thickness of the ventricular posterior wall of the left ventricle in end-diastole, left ventricular mass, percentage of left ventricular ejection fraction.
次要结局
- renal function(3,6, 12 months)
- proteinuria(3,6, 12 months)
- acute rejection episodies(12 months)
研究者
MARIO ABBUD FILHO
MD PHD
Instituto de Urologia e Nefrologia