Recruiting

FIONAFinerenone with ACEI or ARB for Improved Kidney Function in Children with CKD and Proteinuria

Study Aim

This phase 3 study aims to evaluate if Finerenone, when used with ACEI or ARB, can improve kidney function by reducing protein in urine by at least 30% in children with Chronic Kidney Disease (CKD) and proteinuria.

What is being tested

Finerenone (Kerendia, BAY94-8862)

+ Placebo

Drug

Who is being recruted

Urogenital Diseases+13

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 6 Months to 17 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: March 2022

See protocol details

Summary

Principal SponsorBayer

Study ContactBayer Clinical Trials ContactMore contacts

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2022

Actual date on which the first participant was enrolled.

This study focuses on children aged 6 months to less than 18 years who have Chronic Kidney Disease (CKD) and proteinuria, a condition where protein leaks into the urine. The goal is to find a better way to manage these conditions, as current treatments like ACEI or ARB, which help control blood pressure and protein in the urine, do not work for all patients. The study will test if adding a drug called finerenone to ACEI or ARB treatment can improve kidney function and reduce protein in the urine. During the study, participants will take either finerenone or a placebo (a pill that looks like the drug but has no medicine in it) along with their usual ACEI or ARB treatment. Over about 180 days, participants will visit the study site at least 7 times. At these visits, doctors will measure blood pressure, heart rate, temperature, height, and weight; take blood and urine samples; perform physical exams; and ask about medication and any health problems. The main goal is to see if finerenone can reduce the protein in the urine by at least 30% from the start to the end of the study. Doctors will also monitor for any health problems that occur during the study.

Official TitleA 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

NCT05196035

Principal SponsorBayer

Study ContactBayer Clinical Trials ContactMore contacts

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

219 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesProteinuriaSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesUrological ManifestationsDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate

Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed

Participants must have stable kidney function between screening and D0 defined as: For participants with a creatinine of > 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0 For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.

Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening

Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as CKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and severely increased proteinuria as defined by Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or UPCR ≥ 1.0 g/g for patients < 2 years of age or ≥ 2 years of age and with CKD stage 1

Show More Criteria

11 exclusion criteria prevent from participating

Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame

Renal allograft in place

Bilateral renal artery stenosis

Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants will receive finerenone treatment.

Group II

Placebo

Participants will receive placebo to finerenone.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 154 locations

Recruiting

Hospital Universiti Sains Malaysia

Kelantan, MalaysiaOpen Hospital Universiti Sains Malaysia in Google Maps

Recruiting

Lucille Packard Children's Hospital Stanford - Pediatric Nephrology

Palo Alto, United States

Recruiting

Rady Children's Hospital San Diego - Cardiology

San Diego, United States

Recruiting

Memorial Transplant Institute - Pediatric Nephrology

Hollywood, United States

Recruiting

154 Study Centers