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RecruitingTherapeutic exploratory (Phase II)Interventional

FINESSE; Optimization of albuminuria lowering therapies to individual patients with CKD using FINErenone and SEmaglutide (FINESSE-CKD)

Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work as well as they should. When kidneys are damaged, protein can leak into the urine. Doctors measure this using a test called UACR. The FINESSE study is looking at two newer treatments: finerenone (Kerendia) and semaglutide (Rybelsus). Both drugs are taken as daily tablets. Researchers want to learn how well these medicines, either alone or together, can reduce urine protein levels in people with CKD. Participants will take the study tablets and collect urine samples at home and during clinic visits. The trial aims to find the best way to tailor these treatments to individual patients. If successful, this research could help doctors protect kidney function more effectively in the future.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Universitair Medisch Centrum Groningen
Enrolment target
36
Start
30 Apr 2024

What is this study about?

Your kidneys act as filters that clean your blood and remove waste through your urine. In chronic kidney disease, these filters become leaky or scarred. A key warning sign is protein leaking into the urine, known as albuminuria. Doctors test for this because high protein levels are linked to faster kidney decline and a higher risk of heart problems.

The FINESSE trial is exploring how two medicines can help reduce this protein leakage. One medicine is finerenone (Kerendia), which blocks a hormone that causes inflammation and scarring in the kidneys. The other is semaglutide (Rybelsus), a tablet that helps manage blood sugar and has also shown strong potential to protect the kidneys and heart.

By testing different doses and combinations of these tablets, researchers hope to see which approach works best for each person. They are also testing how easy it is for patients to collect urine samples at home. Finding the right treatment balance could help people with kidney disease live healthier lives for longer.

Key takeaways

  • The FINESSE study tests finerenone and semaglutide tablets for chronic kidney disease.
  • The main aim is to lower protein levels in the urine (measured by a UACR test).
  • It is open to adults aged 18 and older with chronic kidney disease.
  • Participants take daily tablets and provide urine samples both at the clinic and at home.
  • Joining is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with chronic kidney disease. Both men and women can take part.

Because the study focuses on reducing protein in the urine, participants will generally need to have raised protein levels (albuminuria) shown on their routine urine tests. The study team will review your medical history and previous test results to see if you qualify.

Not everyone will be able to join. For example, people with certain heart conditions, severe kidney failure needing immediate dialysis, or allergies to the study medicines may not be suitable. Your doctor or the study team can explain the detailed health rules.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have been diagnosed with chronic kidney disease.
  3. My urine tests show raised levels of protein (albuminuria).
  4. I am able and willing to take daily tablets.
  5. I can attend regular clinic visits and collect urine samples at home.
Answer every question to see your result.

What does participation involve?

If you take part, you will be prescribed study tablets to take by mouth once a day. These will include different strengths of semaglutide (Rybelsus) and finerenone (Kerendia). The study team will guide you on exactly how and when to take them.

You will attend regular check-ups at a hospital clinic to monitor your kidney function, blood pressure, and overall health. You will also provide blood and urine samples.

A key part of this study involves collecting urine samples at home. You will be given simple kits and instructions to do this. The study team will track how convenient and practical this home testing is for you. The trial team will confirm the exact number of clinic visits and how many months you will take part before you decide to join.

Potential risks and benefits

Taking part may help lower the amount of protein in your urine and gives you extra health monitoring from kidney specialists. The results will also help improve future kidney care for others. However, there is no guarantee of direct personal benefit. Like all medications, these tablets can cause side effects. Finerenone can sometimes raise potassium levels in the blood, while semaglutide can cause mild tummy upset or nausea, especially when starting. You can leave the study at any time without giving a reason, and your regular NHS medical care will not be affected.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Netherlands
  • —
    Unverified
    Italy
  • —
    Unverified
    Denmark
  • —
    Unverified
    Spain

Common questions

What is the main goal of the FINESSE trial?

The study aims to see how well finerenone and semaglutide reduce protein leakage in the urine of people with chronic kidney disease.

How do I take the study medicines?

Both medications are taken as daily tablets by mouth. The trial doctors will give you clear instructions on the right dose and timing.

Do I have to collect urine samples at home?

Yes, part of the study involves collecting some urine samples at home using kits provided by the clinic, which you then return for testing.

Can I carry on taking my normal medicines?

In most cases, yes, but the study doctor will check all your regular prescriptions to ensure they are safe to take alongside the trial medicines.

What happens if I change my mind about taking part?

You are free to stop participating at any point. Deciding to leave will not affect your standard NHS treatment or your relationship with your doctor.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "FINESSE; Optimization of albuminuria lowering therapies to i…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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