Finerenone and renal oxidative stress

Phase 1

Recruiting

• Conditions: type 2 diabetes mellitus; MedDRA version: 21.1Level: LLTClassification code: 10045242Term: Type II diabetes mellitus Class: 10027433; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-508266-15-00
• Lead Sponsor: niversitaetsklinikum Erlangen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion 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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified