Effects of Finerenone on Renal Hemodynamics and Oxidative Stress

FINE

The main goal of this mechanistic, prospective, double-blind, placebo controlled, randomized study is to demonstrate the effect of finerenone on the oxidative stress of renal vasculature. Moreover, parameters of renal hemodynamics like renal plasma flow, total renal vascular resistance, filtration fraction, parameters of intraglomerular hemodynamics etc. are analyzed in detail. Finally, the change in renal nitric oxide activity with finerenone treatment is analyzed. The primary objective of this mechanistic study is to analyse: - the impact of finerenone on the oxidative stress level of renal vasculature by the increase of renal perfusion following vitamin C infusion compared to placebo

2024-01-18

2025-06-30

2025-12-31

Recruiting

Early phase I

75

Inclusion Criteria: * Age of 18 - 75 years * Diagnosis of type 2 diabetes mellitus (defined by ADA criteria) * Male and Female patients (females of child bearing 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 (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) must be given in written form Exclusion Criteria: * Any other form of diabetes mellitus than type 2 diabetes mellitus * Female who is pregnant, breast feeding or intends to become pregnant. Documentation of highly effective contraception is required for women of childbearing potential. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 months after stopping medication * Use of insulin or GLP-1 analogue 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 * Significant laboratory abnormalities such as serum Glutamate-Oxaloacetate-Transaminase (SGOT) or serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 x above the upper limit of normal range * 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) * Use of other aldosterone receptor antagonist like spironolactone or eplerenone or potassium sparing diuretics or direct renin inhibitors * Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion * Congestive heart failure (CHF) NYHA stage IV * Drug or alcohol abuse * Severe disorders of the gastrointestinal tract or other diseases which interfere with the pharmacodynamics and pharmacokinetics of the study drug * Allergic reaction to iodine * Individuals at risk for poor protocol or medication compliance * Participation in another clinical study within 30 days prior to visit 1 * Patients being treated for severe auto immune disease e.g. lupus, glomerulonephritis * Any patient currently receiving chronic (\>30 consecutive days) treatment with an oral corticosteroid - Patients in unstable conditions due to any kind of serious disease, that interferes with the conduct of the trial * Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized (1:1), prospective, double-blind, placebo controlled, parallel-group, single centre study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2024-02-12