Finerenone and Renal Oxidative Stress (NCT06244758) | Clinical Trial Compass
CompletedPhase 3
Finerenone and Renal Oxidative Stress
Germany91 participantsStarted 2024-01-18
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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…
What they're measuring
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
Timeframe: at baseline and after 3 months on finerenone
Trial details
NCT IDNCT06244758
SponsorUniversity of Erlangen-Nürnberg Medical School