2024-513808-34-00招募中3 期
A randomized crossover clinical trial regarding the blockage of the mineralocorticoid receptor using Eplerenone on the evolution of arterial stiffness in kidney patients one year after transplant: EVATRAN (The effect of Eplerenone on the evolution of Vasculopathy in renal transplant patients).
CHRU De Nancy1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月7日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evolution of pulse wave velocity (PWV in m/s) adjusted to the blood pressure measured by Sphygmocor®, after 6 months of treatment with eplerenone
研究概览
简要总结
To evaluate the impact of a six month administration of eplerenone on arterial stiffness, among stable kidney transplant patients on cyclosporine, transplanted for at least one year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Randomized period (Crossover design)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 50 years of age
- •Patient who had a kidney transplant at least one year prior to inclusion
- •Patient treated with cyclosporine
- •Patient whose clinical-biological state has been stable for at least 3 months: no change in treatment with an impact on blood pressure (excluding immunosuppressive drug) for 3 months, no acute rejection diagnosed within 3 months
- •Patient with a glomerular filtration rate estimated according to the formula CKD-EPI ≥30mL/min/1.73m2
- •Patient with a peripheral PAS≥110mmHg, irrespective of the presence or not of an antihypertensive therapy (including ACE inhibitors or sartan)
- •Patient who signed informed consent
- •Patient affiliated with to beneficiary of a social security system
排除标准
- •Patient with documented kalemia ≥ 5mmol/L in the last 15 days
- •Patient with known galactose intolerance, lactase Lapp deficiency, or glucose, galactose malabsorption syndrom
- •Contraindication to Sodium polystyrène sulfonate (potassium binder) administration : Intestinal obstructive disease and sorbitol laxative treatment
- •Patient participating in other interventional research
- •Female with a desire of pregnancy for the next 15 months
- •Female of childbearing age without effective contraception
- •Pregnant women, parturient women or nursing mothers
- •Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard)
- •Adults person who is unable to give consent and who is not subject to a legal protection measure
- •Persons deprived of their liberty by a judicial or administrative decision
- •persons subject to psychiatric care pursuant to articles L. 3212-1 and L. 3213-1
- •Bicarbonate blood level <20mmol/L with or without documented supplementation in the last 15 days,
- •Patient undergoing mineralocorticoid receptor antagonism or with a formal indication to receive this treatment
- •Patients receiving potassium sparing diuretics
- •Patients treated with a combination of ACEi and ARBs (each of which is authorized separately);
- •Patient undergoing digoxin medication
- •Known hypersensitivity or allergy to eplerenone and its excipients
- •Patient with severe hepatic impairment (Child-Pugh Class C)
- •Patient treated with potent CYP3A4 inhibitor (p.e. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycine, télithromycine et nefazodone)
结局指标
主要结局
Evolution of pulse wave velocity (PWV in m/s) adjusted to the blood pressure measured by Sphygmocor®, after 6 months of treatment with eplerenone
Evolution of pulse wave velocity (PWV in m/s) adjusted to the blood pressure measured by Sphygmocor®, after 6 months of treatment with eplerenone
次要结局
- Evolution after 6 months of treatment of central Systolic Blood Pressure (CSPc), Central Diastolic Blood Pressure (CDAb), Central Pulsed Pressure (CPp), Index of Increase (Aix in %), measured by Sphygmocor® (Atcor medical) applanation tonometry
- Evolution after six months of treatment of Peripheral systolic blood pressure (PASp in mmHg), peripheral diastolic blood pressure (PADp in mmHg), peripheral pulse pressure (PPp in mmHg)
- Evolution after six months of treatment of intima-media thickness (in mm) measured by Echotracking (ART.LAB, ESAOTE®)
- Evolution after six months of treatment of left ventricular mass (LVM in g/m2) measured by cardiac ultrasound
- Evolution after 6 months of treatment of biological markers of oxidative stress (plasma Isoprostane and Malondialdehyde (MDA))
- Evolution after 6 months of treatment of biological markers of endothelial dysfunction (endothelin, soluble endothelium selectin (sE-selectin), von Willebrand factor )
- Graft function measured by blood creatinine (in micromol/L) with estimation of glomerular filtration rate (DFGe in mL/min/1.73m2 ) according to the CKD-EPI formula as well asproteinuria measured by the ratio proteinuria/creatininuria (in mg/g). The percentage of patients with DFG ≥ 90, 60-89, 45-59, 30-44, 15-29, <15ml/min/1.73m2 will also be evaluated, as well as the percentage of patients with ratio proteinuria/creatininuria <500; 500-1000, 1000-2000, 2000-3000, >3000 at 6 months
- Occurrence of hyperkalemia ≥ 5.5 mmol/L and the number of hyperkalemias during hyperkalemia follow-up between 5 - 5.49; 5.5 - 6; >6mmol/L
- Risk of acute renal failure defined as an increase in creatinine of more than 50%.
研究者
Sophie GIRERD
Scientific
CHRU De Nancy
研究点 (1)
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