The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Angiotensin levels (pg/ml) of CKD II-III patients with DM II with eplerenone additional to enalapril in comparison to patients who receive a placebo on top of enalapril therapy.
研究概览
简要总结
In a prospective single centre placebo-controlled trial over ten weeks, 24 CKD II-III patients (eGFR 30-89 ml/min per 1.73 m2) with DM II will be randomized to enalapril 20mg per day after a two week run-in phase. Thereafter, patients will either receive eplerenone 25mg (n=12) or a placebo (n=12) for eight weeks. Eplerenone will be increased to 50mg under close monitoring of serum potassium levels. Employing a novel mass-spectrometry ( MS)-based method, quantification of up to 10 different Ang metabolites (Ang I, Ang II, Ang 1-7, Ang 1-9, Ang 2-10, Ang 1-5, Ang 2-7, Ang 3-7, Ang 3-8 and Ang 2-8) will be performed simultaneously out of blood sera (after run-in phase and after 10 weeks).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD II to III and diabetes mellitus type 2
- •CKD will be defined according to estimated glomerular filtration rate (eGFR) with the MDRD formula
- •eGFR between 30 and 89 ml/min
- •albumin excretion rates > 300 mg/24 hours (UACR > 300 mg/gram) or > 200 mg/g if already receiving any RAS blockade Patients should be hypertonic stage I or II according to the European guidelines (Chobanian et al. JAMA 2003)
排除标准
- •Age < 18 years
- •UACR > 3500mg/g
- •severe hypertension
- •pregnancy
- •unwilling or inability to sign the informed consent
- •coronary heart disease
- •systolic blood pressure < 130 mmHg
- •additional RAS interfering drugs (ACEis, ARBs, direct renin inhibitors)
- •25-hydroxy vitamin D levels below 16.6±8.3 pg/ml
- •1,25-dihydroxy vitamin D 33.1±15.5 pg/ml
- •Intolerance to eplerenon or an excipient of it:
- •tablettcore: Lactose-Monohydrat Mikrokristalline Cellulose (E 460) Croscarmellose-sodium (E 468) Hypromellose (E 464) Sodiumdodecylsulfat Talkum (E 553b) Magnesiumstearat (E 470b)
- •Opadry, yellow:
- •Hypromellose (E 464) Titandioxid (E 171) Macrogol 400 Polysorbat 80 (E 433) Yellow ironoxide (E 172) Red ironoxide (E 172)
- •Patients with Serumpotassium > 5,0 mmol/l at start of the treatment
- •Patients with severe renal insufficiency (eGFR <30ml/min./1.73 m2)
- •Patients with severe liver insufficiency (Child-Pugh class C)
- •Patients taking potassium saving diuretics, potassium supplements or strong CYP3A4-inhibitors (z. B. Itraconazol, Ketoconazol, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin und Nefazodon)
研究组 & 干预措施
Eplerenone
Eplerenone 25-50mg daily additionally to standard ACE-inhibition with enalapril 20mg daily
干预措施: Eplerenone (Drug)
Placebo
Placebo additionally to standard ACE-inhibition with enalapril 20mg daily
干预措施: Placebo (Drug)
结局指标
主要结局
Angiotensin levels (pg/ml) of CKD II-III patients with DM II with eplerenone additional to enalapril in comparison to patients who receive a placebo on top of enalapril therapy.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Marcus Saemann
Assoc. Prof. Priv.-Doz. Dr.med.univ.
Medical University of Vienna