Effects of Finerenone on Renal Hemodynamics and Oxidative Stress - FINE

niversitaetsklinikum Erlangen AöR0 个研究点目标入组 75 人开始时间: 2023年10月9日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•age of 18 - 75 years, diagnosis of type 2 diabetes mellitus (defined by ADA criteria), male and female patients (females of childbearing potential must be using effective contraceptive precautions per CTFG quidance), females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit, informed consent must be given in written form

•any other form of diabetes mellitus than type 2 diabetes mellitus, use of other aldosterone receptor antagonist like spironolactone or eplerenone or potassium sparing diuretics or direct renin inhibitors, congestive heart failure (CHF) NYHA stage IV, use of GLP-1 analogue for weight loss or insulin within the past 3 months, HbA1c = 10.5%, serum potassium > 4.8 mmol/l, body mass index > 40 kg/m², estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m² (CKD-EPI Formula), uncontrolled arterial hypertension (BP = 180/110 mmHg), subclinical or clinical hyperthyroidism, use of strong CYP3A4-Inhibitors (for example Itraconazol, Clarithromycin, Ketoconazol, Ritonavir, Nelfinavir, Cobicistat, Telithromycin, Nefazodon) or CYP3A4-Inducers (for example Rifampicin, Carbamazepin, Phenytoin, Phenobarbital, St. John’s wort (Johanniskraut), Efavirenz)

发起方

niversitaetsklinikum Erlangen AöR