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Study on the Effects of Finerenone on Kidney Health in Patients with Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called finerenone on kidney health, specifically looking at how it affects oxidative stress in the blood vessels of the kidneys. Oxidative stress is a condition where there is an imbalance between free radicals and antioxidants in the body, which can lead to cell damage. The study involves participants who have type 2 diabetes mellitus, a common condition where the body does not use insulin properly, leading to high blood sugar levels.

Participants in the study will receive either Kerendia (finerenone) in the form of film-coated tablets or a placebo, which looks like the medication but does not contain any active ingredients. The study will also use a diagnostic agent called aminohippuric acid and a contrast agent known as iohexol to help assess kidney function. Additionally, L-arginine hydrochloride and ascorbic acid (commonly known as Vitamin C) will be used during the study to further understand their effects on kidney health.

The purpose of the study is to determine how finerenone impacts oxidative stress in the kidneys by observing changes in kidney blood flow after Vitamin C is given, compared to the placebo. Participants will take part in the study over a period of time, during which they will receive the study medication or placebo and undergo various assessments to monitor their kidney health and overall well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age (18-75 years) and a diagnosis of type 2 diabetes mellitus.
A urine pregnancy test will be conducted for females of childbearing potential or those within two years of menopause. Written informed consent is required to proceed.
Step 2
Baseline assessment
You will undergo a baseline assessment to evaluate your current health status. This may include blood tests and other evaluations to establish a starting point for the study.
Step 3
Medication administration
You will be assigned to receive either Kerendia 10 mg or Kerendia 20 mg film-coated tablets, or a placebo. The tablets are taken orally once daily.
The duration of this medication phase will be specified by the study team, and you will be required to adhere to the prescribed dosage and schedule.
Step 4
Infusion sessions
You will participate in infusion sessions where you will receive Vitamin C or a placebo through an infusion. This is to assess the impact on oxidative stress in the kidneys.
The frequency and duration of these sessions will be communicated to you by the study team.
Step 5
Follow-up visits
Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits will include assessments similar to the baseline assessment.
It is important to attend all scheduled visits to ensure accurate data collection and monitoring.
Step 6
Final assessment
At the end of the study period, a final assessment will be conducted. This will involve similar evaluations to those performed at the baseline and during follow-up visits.
The results will help determine the effect of finerenone on oxidative stress in the kidneys.

Who can join the trial?

6 criteria

Age between 18 and 75 years
Diagnosis of type 2 diabetes mellitus (as defined by the American Diabetes Association criteria)
Both male and female patients can participate
Females who can have children must use effective birth control methods
Females who can have children or are within two years of menopause must have a negative urine pregnancy test at the screening visit
Must provide written informed consent to participate in the study

Who cannot join the trial?

3 criteria

Patients with **type 2 diabetes mellitus** cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Universitaetsklinikum Erlangen AöR
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Erlangen, Germany

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Investigated drugs

Finerenone is a medication being studied for its effects on the kidneys, specifically how it might help reduce oxidative stress in the blood vessels of the kidneys. Oxidative stress is a condition where there is an imbalance between free radicals and antioxidants in the body, which can lead to damage. By potentially reducing this stress, finerenone may help protect the kidneys and improve their function. This medication is being tested to see if it can provide benefits for people with kidney issues, particularly in how their blood vessels work.

What is already known about the treatment

Finerenone – Finerenone is administered orally in tablet form and is currently being studied for its effects on kidney function and oxidative stress in patients with type 2 diabetes mellitus. It is a relatively new medication in the medical field, with ongoing research to better understand its benefits and potential uses. The main therapeutic indication for finerenone is to manage kidney-related complications in type 2 diabetes. At the molecular level, finerenone works by blocking certain receptors in the body that contribute to inflammation and fibrosis, which can damage the kidneys. It is classified as a non-steroidal mineralocorticoid receptor antagonist, which means it helps protect the kidneys by reducing harmful effects caused by certain hormones.

Investigated diseases

Type 2 diabetes mellitus – Type 2 diabetes mellitus is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As the condition progresses, individuals may experience more severe symptoms and complications. Management of blood sugar levels is crucial to prevent further progression and complications.