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Finerenone and Renal Oxidative Stress

NCT06244758 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-04-02

No results posted yet for this study

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

Interventions

DRUG

Finerenone 20 MG Oral Tablet

The intervention is administered orally.

DRUG

Placebo

The intervention is administered orally.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Dennis Kannenkeril, MD · University Hospital Erlangen

  • Roland E. Schmieder, MD · University Hospital Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2025-11-25
Completion
2025-11-25

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06244758 on ClinicalTrials.gov