Finerenone and Renal Oxidative Stress

NCT06244758 | Completed Phase 3

• 1 other identifier: FINE
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (1)

• 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

  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

  at baseline and after 3 months on finerenone

Secondary Outcomes (6)

• impact of finerenone on renal plasma flow (para-aminohippurate (PAH) clearance) compared to placebo

  at baseline and after 3 months on finerenone

• impact of finerenone on glomerular filtration rate (iohexol clearance) compared to placebo

  at baseline and after 3 months on finerenone

• impact of finerenone on filtration fraction compared to placebo

  at baseline and after 3 months on finerenone

• impact of finerenone on total renal vascular resistance compared to placebo

  at baseline and after 3 months on finerenone

• impact of finerenone on intraglomerular resistances (resistance of the afferent and efferent arterioles) and intraglomerular pressure (GOMEZ formulae) compared to placebo

  at baseline and after 3 months on finerenone

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Renal hemodynamic parameters and oxidative stress will be obtained and the patient will be given finerenone orally

Drug: Finerenone 20 MG Oral Tablet

Placebo

PLACEBO COMPARATOR

Renal hemodynamic parameters and oxidative stress will be obtained and the patient will be given placebo orally

Drug: Placebo

Interventions

Finerenone 20 MG Oral Tablet DRUG

The intervention is administered orally.

Treatment

Placebo DRUG

The intervention is administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Bayer: collaborator

Study Sites (1)

Clinical Research Center Erlangen, Department of Nephrology and Hypertension, University Hospital Erlangen

Erlangen, Germany

Location

MeSH Terms

Interventions

finerenone; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dennis Kannenkeril, MD

  University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

• Roland E. Schmieder, MD

  University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized (1:1), prospective, double-blind, placebo controlled, parallel-group, single centre study

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: January 18, 2024
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)