Effect of finerenone on kidney oxidative stress in type 2 diabetes
Effects of Finerenone on Renal Hemodynamics and Oxidative Stress
This study tests if the medication finerenone can help reduce kidney stress in people with type 2 diabetes compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT06244758 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the impact of finerenone on oxidative stress in the renal vasculature of patients with type 2 diabetes. It employs a double-blind, placebo-controlled, randomized design to analyze various renal hemodynamic parameters and changes in nitric oxide activity following treatment. The study will assess how finerenone influences renal perfusion and oxidative stress levels compared to a placebo, providing insights into its potential benefits for kidney health in diabetic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of type 2 diabetes mellitus.
Not a fit: Patients with forms of diabetes other than type 2 diabetes or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney function and reduced cardiovascular risks for patients with type 2 diabetes.
How similar studies have performed: Previous studies, such as FIDELIO and FIGARO, have shown that finerenone can reduce risks associated with chronic kidney disease and cardiovascular events, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erlangen
- Clinical Research Center Erlangen, Department of Nephrology and Hypertension, University Hospital Erlangen — Erlangen, Germany (Recruiting)
Study contacts
- Principal investigator: Dennis Kannenkeril, MD — University Hospital Erlangen
- Study coordinator: Dennis Kannenkeril, MD
- Email: dennis.kannenkeril@uk-erlangen.de
- Phone: +49 9131 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.