Finerenone and Renal Oxidative Stress

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Jan 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called finerenone on the kidneys of people with type 2 diabetes. The main goal is to see if finerenone can reduce oxidative stress in the kidney blood vessels, which is a condition that can damage these important organs. Researchers will closely analyze how finerenone affects blood flow and other functions in the kidneys, especially after giving vitamin C, which helps measure changes in kidney activity.

To participate in this study, individuals must be between 18 and 75 years old and diagnosed with type 2 diabetes. Women who can become pregnant need to use effective birth control during the study. Participants will receive either finerenone or a placebo (a dummy treatment) but won’t know which one they’re getting. Throughout the trial, participants can expect regular check-ups and monitoring to observe how their kidneys respond to the treatment. It’s important to note that some people may not qualify for the study due to certain health conditions or medications they are taking.

Gender

ALL

Eligibility criteria

• 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