A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the
efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in
addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with
chronic kidney disease and proteinuria

Researchers are looking for a better way to treat children who have chronic
kidney disease (CKD), which is long-term kidney disease, and proteinuria, a
condition in which a person*s kidneys leak protein into the urine. The kidneys
filter waste and fluid from the blood to form urine.

In children with CKD, the kidney*s filters do not work as well as they should.
This can lead to accumulation of waste and fluid in the body and proteinuria.
CKD can lead to other medical problems, such as high blood pressure, also known
as hypertension. Vice versa, hypertension and proteinuria can also contribute
to worsening of CKD. Therefore, the treatment of CKD aims to control blood
pressure and proteinuria. There are treatments available for doctors to
prescribe to children with CKD and hypertension and/or proteinuria. These
include *angiotensin-converting enzyme inhibitors* (ACEI) and *angiotensin
receptor blockers* (ARB). Both ACEI and ARB can improve kidney function by
helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The
RAAS is a system that works with the kidneys to control blood pressure and the
balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is
often too active, which can stop the kidneys from working properly and cause
hypertension and proteinuria. However, ACEI or ARB treatment alone does not
work for all patients with CKD as they only target the angiotensin part of the
renin-angiotensin-aldosterone system.

The study treatment, finerenone, blocks aldosterone and is another treatment
that doctors can prescribe to help patients whose kidneys are not working
normally. Finerenone helps to control RAAS overactivation together with an ACEI
or ARB. The researchers think that finerenone may help the kidney function of
children with CKD.

So, the researchers in this study want to learn more about whether finerenone
given in addition to either an ACEI or ARB can help their kidney function.

This study has been transitioned to CTIS with ID 2023-504884-17-00 check the CTIS register for the current data.

The main goal of this study is to find out whether finerenone in combination
with either an ACE inhibitor or an ARB can reduce the amount of protein in the
participants' urine more than a placebo. A placebo looks like a drug, but
contains no active ingredient. The participants also continue to use their
other medication.

A 6-month multicenter, randomized, double-blind, placebo-controlled study to
evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral
finerenone regimen, in addition to an ACEI or ARB, for the treatment of
children, 6 months to <18 years of age, with chronic kidney disease and
proteinuria.

BAY 94-8862: film-coated tablets 10 mg or 20 mg orally
BAY 94-8862 GRAN SUSP 3.4% 3 g ORAL: 2 mg/ml suspension (made from granules,
equivalent by body weight) orally
or comparable placebo

There are 12 visits (1 run-in and screening, randomization and close-out visit
and 8 regular visits)
- The patient is asked 3 times to complete 2 questionnaires.
- The patient is asked to submit urine 5-7 times
- The patient is asked to keep a handbook/diary from randomization
- The patient is not allowed to consume products containing grapefruit and St
John's wort
- During each visit, vital signs are functions checked
- Weight and height are determined during approximately half of the visits
All visits during the entire study will take approximately 20 hours.
Measurements:
Vital Signs: Pulse Rate, No Risks,
Vital Signs: Blood Pressure, No Risk: Possible discomfort around the arm due to
the blood pressure cuff.
Body weight and height: No risks,
Blood draws: Risks: Pain, Bruising, Feeling faint or dizzy, Infection.
Urine collection: no risk
Electrocardiogram (ECG): Risk: Skin irritation,
Echocardiography: no risk
BAY 94-8862 may have a therapeutic benefit, however this cannot be guaranteed.
Patients are at risk of side effects.