Study on Reducing Protein in Urine for Patients with Chronic Kidney Disease Using Finerenone and Semaglutide

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What is this study about?

This clinical trial is focused on improving treatment for patients with Chronic Kidney Disease (CKD). The study will explore the effects of two medications: finerenone and semaglutide. Finerenone is a medication that helps reduce the amount of protein in the urine, which is a common issue in CKD. Semaglutide, also known by its code name NNC0113-0217, is a medication that helps control blood sugar levels and may also have benefits for kidney health.

The purpose of the study is to determine if either finerenone or semaglutide can reduce the amount of protein in the urine by at least 30% in a significant number of patients. Participants will be given either finerenone, semaglutide, or a placebo to see which treatment works best for them. The study will last for several months, with regular check-ups to monitor the effects of the medication on kidney function and overall health.

Throughout the study, participants will take their assigned medication orally in the form of tablets. The study aims to find the best treatment option for each individual, potentially leading to better management of Chronic Kidney Disease. The results will help doctors understand how these medications can be used to improve the health of people with CKD.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to improve albuminuria in patients with chronic kidney disease using finerenone and semaglutide.

The patient will be required to sign an informed consent form to confirm their willingness to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility, which includes checking age, urinary albumin to creatinine ratio, estimated glomerular filtration rate (eGFR), and HbA1c levels.

The patient must be on a stable dose of an ACE inhibitor or ARB and an SGLT2 inhibitor for at least 4 weeks if tolerated.

3 medication administration

The patient will be assigned to receive either Rybelsus (semaglutide) or Kerendia (finerenone) based on individual suitability.

Rybelsus is available in 3 mg, 7 mg, and 14 mg tablets, and is taken orally.

Kerendia is available in 20 mg film-coated tablets, and is also taken orally.

4 monitoring and follow-up

The patient will be monitored regularly to assess the percentage change from baseline in urinary albumin to creatinine ratio (UACR).

The patient will be required to report any missed urine collections, especially those conducted at home.

5 completion of the trial

The trial is expected to conclude by December 31, 2025.

Upon completion, the patient will be informed of the results and any further steps if necessary.

Who Can Join the Study?

Must be 18 years or older.
Have a urinary albumin to creatinine ratio between 100 mg/g and 3500 mg/g. This is a test that measures the amount of a protein called albumin in your urine compared to a waste product called creatinine.
Have an eGFR between 25 and 90 mL/min/1.73m². eGFR is a test that checks how well your kidneys are working.
Have an HbA1c level between 5.7% and less than 11%. HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months.
Be on a stable dose of an ACEi/ARB for at least 4 weeks if you can tolerate it. These are types of medications used to treat high blood pressure and kidney problems.
Be on a stable dose of an SGLT2 inhibitor for at least 4 weeks if you can tolerate it. This is a type of medication used to lower blood sugar levels.
Willing to sign an informed consent. This means you agree to participate in the study after being told all the important details.

Who Cannot Join the Study?

Patients who do not have Chronic Kidney Disease cannot participate. This is a condition where the kidneys are damaged and cannot filter blood as well as they should.
Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 64 years old.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like those with certain disabilities or those who are unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Steno Diabetes Center Copenhagen	Herlev	Denmark
Hospital Clinico Universitario De Valencia	Valencia	Spain
Uetbnshbbr oi Chuadeof	Rende	Italy
Aatacikxf Ujr	Amsterdam	The Netherlands
Hyoacnbg Vblr dygrfrkg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	30.06.2024
Italy	Not recruiting	30.06.2024
Spain	Not recruiting	30.06.2024
The Netherlands	Not recruiting	30.06.2024

Trial locations

Finerenone is a medication used in this trial to help reduce albuminuria, which is a condition where there is too much protein in the urine. This medication is being tested to see if it can effectively lower the levels of albumin in patients with chronic kidney disease (CKD) when chosen as the best option for the individual patient.

Semaglutide is another medication involved in the trial. It is used to help lower albuminuria in patients with chronic kidney disease. The trial aims to determine if semaglutide can achieve a significant reduction in albumin levels when it is selected as the most suitable treatment for a patient.

Chronic Kidney Disease – This condition involves the gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of the disease can vary, with some people experiencing a slow decline in kidney function, while others may have a more rapid deterioration. Chronic kidney disease can eventually lead to kidney failure if not managed properly.

Trial ID:

2023-506434-69-00

Protocol code:

17456

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Reducing Protein in Urine for Patients with Chronic Kidney Disease Using Finerenone and Semaglutide

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?