Finerenone and Renal Oxidative Stress

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT06244758
Phase
PHASE3
Status
Completed

Conditions

  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Jan 18, 2024
Status verified
Mar 2026
Primary completion
Nov 25, 2025
Completion
Nov 25, 2025

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment
    Renal hemodynamic parameters and oxidative stress will be obtained and the patient will be given finerenone orally
  • Placebo Comparator: Placebo
    Renal hemodynamic parameters and oxidative stress will be obtained and the patient will be given placebo orally

Primary Outcome Measure

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 [ Time Frame: at baseline and after 3 months on finerenone ]

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