Remote Study on Empagliflozin and Finerenone for Reducing Kidney Issues in Type 2 Diabetes Patients

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What is this study about?

This clinical trial focuses on individuals with Type 2 Diabetes and a condition called Albuminuria, which involves having a higher than normal amount of a protein called albumin in the urine. The study will explore the use of two medications: Empagliflozin and Finerenone. Empagliflozin is a medication that helps control blood sugar levels, while Finerenone is used to protect the kidneys by reducing inflammation and scarring.

The purpose of the study is to see how well these medications can be used together to improve kidney health in people with Type 2 Diabetes. Participants will take either Empagliflozin or Finerenone, or a combination of both, in the form of film-coated tablets. The study will be conducted remotely, meaning participants can take part from their own homes using digital technologies. This approach aims to make it easier for people to participate without needing to visit a clinic frequently.

Throughout the study, participants will be asked to provide urine samples and monitor their blood pressure and body weight. The study will last for several weeks, and participants will be asked to take their medication as directed. The researchers will collect information on how participants feel about taking part in a remote trial and how well they adhere to the treatment plan. The study will also look at changes in kidney function, blood pressure, and blood sugar levels to understand the effects of the medications better.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of type 2 diabetes, and specific health measurements.

Informed consent is required, and proficiency in the Dutch language is necessary.

2 initial assessment

An initial assessment is conducted to establish baseline health metrics, including urine albumin-to-creatinine ratio (UACR), blood pressure, body weight, estimated glomerular filtration rate (eGFR), and fasting plasma glucose levels.

3 medication administration

The study involves the administration of empagliflozin and finerenone, both taken orally as film-coated tablets.

Empagliflozin is provided as Jardiance 10 mg tablets, and finerenone is available in Kerendia 10 mg and Kerendia 20 mg tablets.

The dosage and frequency of administration are determined by the study protocol and adjusted based on individual response.

4 ongoing monitoring

Participants are required to regularly monitor and report health metrics such as blood pressure and body weight.

Urine samples are collected and sent to a laboratory for analysis to ensure adherence to the treatment and to monitor changes in UACR.

5 treatment evaluation

The effectiveness of the treatment is evaluated by comparing changes in health metrics from the start to the end of the treatment period.

Primary endpoints include participants’ perspectives on the feasibility of participating in a remote trial and adherence to the treatment regimen.

6 completion of the study

The study is estimated to conclude by October 31, 2024.

Final assessments are conducted to evaluate the overall impact of the treatment on kidney health and other health metrics.

Who Can Join the Study?

Must be at least 18 years old.
Must have a diagnosis of type 2 diabetes, a condition where the body doesn’t use insulin properly.
Must have a UACR (Urinary Albumin-to-Creatinine Ratio) greater than 4.5 mg/mmol (more than 40 mg/g) and less than or equal to 300 mg/mmol (up to 2655 mg/g). This is a measure of how much protein is in the urine.
Must have an eGFR (estimated Glomerular Filtration Rate) of at least 25 mL/min/1.73m². This is a test to check how well the kidneys are working.
Must be on a stable dose of an ACE inhibitor or ARB if tolerated. These are types of medications used to treat high blood pressure and other conditions.
Must be willing to sign an informed consent form, which means agreeing to participate in the study after understanding all the details.
Must be proficient in the Dutch language, meaning able to speak and understand Dutch well.

Who Cannot Join the Study?

Patients who do not have Type 2 diabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Patients who do not have elevated albuminuria cannot participate. Albuminuria is a condition where there is too much of a protein called albumin in the urine, which can be a sign of kidney problems.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population are not excluded. A vulnerable population includes groups who may need special protection, but this study does not exclude them.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Empagliflozin is a medication used to help lower blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove glucose from the bloodstream through urine. In this trial, it is being used to see if it can also help reduce albuminuria, which is a condition where there is too much protein in the urine, often a sign of kidney damage.

Finerenone is a medication that helps protect the kidneys by blocking certain hormones that can cause damage. It is used in this trial to see if it can help reduce albuminuria in patients with type 2 diabetes, potentially slowing down kidney damage and improving kidney health.

Investigated diseases:

Albuminuria

Albuminuria – Albuminuria is a condition characterized by the presence of an abnormal amount of albumin, a type of protein, in the urine. It often indicates that the kidneys are not functioning properly, as they are allowing protein to leak into the urine. This condition can progress gradually, with increasing levels of albumin in the urine over time. It is commonly associated with kidney damage or disease, and can be a sign of underlying health issues such as diabetes or hypertension. Monitoring albuminuria is important for assessing kidney health and function.

Type 2 Diabetes – Type 2 diabetes 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, leading to elevated blood sugar levels. Over time, the pancreas may not produce enough insulin to maintain normal glucose levels. This condition can develop gradually, often without noticeable symptoms in the early stages. It is commonly associated with lifestyle factors such as diet and physical activity, and can lead to complications if not managed properly.

Trial ID:

2023-508585-15-00

Protocol code:

18253

NCT ID:

NCT06094920

Trial Phase:

Therapeutic confirmatory (Phase III)

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Remote Study on Empagliflozin and Finerenone for Reducing Kidney Issues in Type 2 Diabetes Patients

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