RecruitingPHASE3INTERVENTIONAL

A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

This study, called FIONA-O, is for children and young people aged 1 to 18 who have long-term kidney disease (chronic kidney disease) and too much protein in their urine (proteinuria). Researchers want to find out how safe a new medicine called finerenone is when taken for a long time (up to 18 months) alongside their usual kidney medicines, like ACE inhibitors or ARBs. They also want to see if finerenone helps reduce the amount of protein leaking into the urine, which is a sign of kidney damage. The study will bring participants back over 19 months to monitor their health and collect samples, focusing on how safe the treatment is and if it helps their kidneys work better.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bayer

Enrolment target

100

Start

08 Nov 2022

Estimated completion

27 Feb 2029

Chronic Kidney Disease Proteinuria Children

What is this study about?

Imagine your kidneys as very important filters that clean your blood and remove waste. In children with **long-term kidney disease (Chronic Kidney Disease)**, these filters don't work as well as they should. This can lead to waste building up in the body and a condition called **proteinuria**, where too much protein leaks from the kidneys into the urine. Over time, this can cause other health problems like high blood pressure, and high blood pressure can also make kidney disease worse.

Currently, doctors often prescribe medicines like ACE inhibitors or ARBs to help control blood pressure and protect the kidneys. These medicines work by calming down a system in the body that can become overactive in kidney disease, but they don't always fully fix the problem. This study is testing a new medicine called **finerenone (also known as Kerendia)**. The researchers believe finerenone might work alongside ACE inhibitors or ARBs to help control this overactive system even better, potentially improving kidney health.

The main goal of this study is to understand how safe finerenone is when children and young people take it for a long period (up to 18 months) with their current kidney medicines. Researchers will carefully check for any side effects and monitor important things like potassium levels in the blood and blood pressure. They also want to see if finerenone can help reduce the amount of protein in the urine, which would be a good sign that the kidneys are working better. This is important because finding effective and safe treatments for children with kidney disease can significantly improve their long-term health.

Key takeaways

This study is for 1-18 year olds with long-term kidney disease and protein in their urine.
It's testing a new medicine, finerenone, alongside current treatments to see how safe it is over time.
Researchers also want to know if finerenone helps reduce protein in the urine and improve kidney function.
Participation involves regular clinic visits for approximately 19 months.
You will have physical examinations, blood/urine tests, and heart checks throughout the study.
Your health will be closely monitored for any side effects.

Who may be eligible?

This study is looking for children and young people between 1 and 18 years old who have **long-term kidney disease (CKD stages 1-3)** and were part of a previous study called FIONA. You must still be taking an ACE inhibitor or ARB medicine for your kidneys, and your dose should have been stable for at least 30 days before joining this study. Your potassium levels also need to be within a certain range.

There are some reasons why you wouldn't be able to join. For example, if you are planning to have kidney surgery or a kidney transplant soon, or if your blood pressure is too high (Stage 2 hypertension) or too low (symptomatic hypotension). You also can't join if you're allergic to finerenone or have severe liver problems. You will also need to be able to eat or drink normally, or have a feeding tube.

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.

Are you between 1 and 18 years old?
Do you have long-term kidney disease (CKD stages 1-3)?
Did you take part in the previous FIONA study and didn't stop treatment early?
Are you currently taking an ACE inhibitor or ARB for your kidneys, and has your dose been stable for at least a month?
Is your blood potassium level within the specified range (your doctor can check this)?
Are you able to eat and drink normally (or use a feeding tube)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of it for about 19 months. You'll take the study medicine, finerenone, for up to 18 months, followed by a 1-month check-up period. During this time, you'll visit the clinic regularly. If you're new to finerenone, you'll have at least 12 visits. If you've been taking it before, you'll have at least 8 visits.

At each visit, the study team will: check your blood pressure, heart rate, temperature, height, and weight; take blood and urine samples; do a health check-up; check your heart with an ECG (heart tracing) and echocardiogram (heart scan); and ask you (or your parents/guardians) questions about your medicines, how you're feeling, any side effects you've noticed, and how you like the study medicine.

After you take your last dose of the study medicine, the doctors will check your health one more time about 30 days later. Throughout the study, the doctors will keep a close eye on your health and record any medical problems you experience, whether they believe they are related to the study medicine or not.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, as finerenone could help improve your kidney function and reduce protein in your urine. However, it's also possible you might not experience any direct benefit. As with any medicine, there are potential risks, and finerenone may cause side effects, which the study team will closely monitor. You will be told about these side effects before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (179)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Phoenix Children's Hospital | Main - Transplant Department
Verified postcode
Phoenix, United States· Withdrawn
Cedars-Sinai Samuel Oschin Cancer Center
Verified postcode
Los Angeles, United States· Withdrawn
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Verified postcode
Palo Alto, United States· Recruiting
Rady Children's Hospital San Diego - Cardiology
Verified postcode
San Diego, United States· Not yet recruiting
Children's National Hospital - Nephrology
Verified postcode
Washington D.C., United States· Not yet recruiting
Memorial Transplant Institute - Pediatric Nephrology
Verified postcode
Hollywood, United States· Not yet recruiting
Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
Verified postcode
Atlanta, United States· Withdrawn
University of Iowa Health Care Medical Center - Nephrology
Verified postcode
Iowa City, United States· Withdrawn
The Charlotte R. Bloomberg Children's Center Building - Nephrology
Verified postcode
Baltimore, United States· Recruiting
Boston Children's Hospital - Main Campus - Nephrology
Verified postcode
Boston, United States· Withdrawn
Children's Mercy Hospital Kansas City - Nephrology
Verified postcode
Kansas City, United States· Not yet recruiting
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Verified postcode
Cincinnati, United States· Not yet recruiting

Common questions

What is long-term kidney disease?

It means your kidneys aren't filtering blood as well as they should, which can cause waste to build up in your body.

What is proteinuria?

This means there's too much protein in your urine, which can be a sign that your kidneys are not working properly.

Who can join this study?

Children and young people aged 1 to 18 with long-term kidney disease and proteinuria, who previously participated in the FIONA study and are taking other specific kidney medicines.

How long will the study last?

You'll be in the study for about 19 months, taking the medicine for up to 18 months and then having a final check-up.

What do I need to do during the study?

You'll have regular clinic visits for physical exams, blood and urine tests, heart checks, and questions about your health and feelings.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

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