Finerenone and renal oxidative stress
Key facts
- Where
- Erlangen, NémetországSee the site
- Phase
- 3. fázis
Where in Németország
- Universitaetsklinikum Erlangen AöRErlangen, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Erlangen AöR
- Trial code
- EU 2023-508266-15-00
- Record updated
- 2024. augusztus 16.
- Original description
The main goal is to demonstrate the effect of finerenone on the oxidative stress of renal vasculature.Read full original descriptionShow less
Effects of Finerenone on Renal Hemodynamics and Oxidative Stress
The main goal is to demonstrate the effect of finerenone on the oxidative stress of renal vasculature.
Inclusion: 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.
Exclusion: 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); any other form of diabetes mellitus than type 2 diabetes mellitus; congestive heart failure (CHF) NYHA stage IV; uncontrolled arterial hypertension (BP ≥ 180/110 mmHg); use of other aldosterone receptor antagonist like spironolactone or eplerenone or potassium sparing diuretics or direct renin inhibitors; HbA1c ≥ 10.5%; serum potassium > 4.8 mmol/l; estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m² (CKD-EPI Formula); use of GLP-1 analogue for weight loss or insulin within the past 3 months; body mass index > 40 kg/m²; subclinical or clinical hyperthyroidism.