2023-508266-15-00CompletedPhase 3
Finerenone and renal oxidative stress
Effects of Finerenone on Renal Hemodynamics and Oxidative Stress
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Aug 2024
Brief summary (registry, in English)
The main goal is to demonstrate the effect of finerenone on the oxidative stress of renal vasculature.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 9 Oct 2023
- Start date
- 18 Jan 2024
- Lead sponsor
- Universitaetsklinikum Erlangen AöR
- Diseases
- Type 2 diabetes
- EU CT number
- 2023-508266-15-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 75
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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)
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Erlangen AöR | Erlangen | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.