Kidney stress study reveals Finerenone's inner workings

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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