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Finerenone and renal oxidative stress
EU CTIS ID: 2023-508266-15-00
What this study is testing
The main goal is to demonstrate the effect of finerenone on the oxidative stress of renal vasculature.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.