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New kidney drug could help kids with protein leak

NCT ID NCT05196035

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests whether adding finerenone to standard blood pressure medicines can reduce protein in the urine of children with chronic kidney disease. About 219 children aged 6 months to under 18 years will take either finerenone or a placebo for 6 months. The main goal is to see if the drug lowers urine protein levels more than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Finerenone (Kerendia)
What this could lead to
If it works, this could provide a new treatment option for children with chronic kidney disease to better control protein in the urine and slow kidney damage.
What could go wrong
This is still being tested in a relatively small group of children. It may not work better than existing treatments, and side effects like high potassium or low blood pressure are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 219 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed * 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 * 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 * K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children \<2 years of age at both screening and D0 Exclusion Criteria: * Planned urological surgery expected to influence renal function * Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening * Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening * 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 * Acute kidney injury requiring dialysis within 6 months prior to screening * Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization * Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to \<1 year of age at screening or randomization * Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is \< 80 mmHg they must be excluded if their SBP is \<80 mmHg) * Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within \<6 months prior to screening

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome proteinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Proteinuria

Contacts and locations

Locations

  • A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica

    Torino, 10126, Italy

  • AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie

    Vienna, Vorarlberg, 6800, Austria

  • APHP - Hopital Robert Debre

    Paris, Île-de-France Region, 75019, France

  • Aarhus Universitetshospital - Børn og Unge

    Aarhus N, Central Denmark Region / Region Midtjylland, 8200, Denmark

  • Alberta Children's Hospital | Nephrology Clinic

    Calgary, Alberta, T3B 6A8, Canada

  • All India Institute of Medical Sciences (AIIMS) - New Delhi

    Delhi, National Capital Territory of Delhi, 110029, India

  • Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi

    Florence, 50139, Italy

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria

    Bologna, 40138, Italy

  • Baskent Universitesi Tip Fakultesi Hastanesi

    Ankara, 6490, Turkey (Türkiye)

  • CHC Montlégia - Pediatrics

    Liège, 4000, Belgium

  • CHU Lyon - Hopital Femme Mere Enfant - Service de nephrologie-rhumatologie-dermatologie pediatriques

    Bron, 69500, France

  • CHU Montpellier - Hopital Arnaud de Villeneuve - Service nephrologie pediatrique

    Montpellier, 34295, France

  • CHU Strasbourg - Hopital Hautepierre - Service nephrologie pediatrique

    Strasbourg, 67200, France

  • CHU Toulouse - Hopital des enfants

    Toulouse, Occitanie, 31059, France

  • CHU bordeaux - Hopital Pellegrin

    Bordeaux, New Aquitaine, 33076, France

  • CU Saint-Luc/UZ St-Luc

    Brussels, Brussels Capital, 1200, Belgium

  • Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne University Hospital

    Lausanne, Canton of Vaud, 1012, Switzerland

  • Centre hospitalier universitaire Sainte-Justine | Cardiology

    Montreal, Quebec, H3T 1C5, Canada

  • Centro de Rehabilitacion Cardiovascular | San Luis, Argentina

    San Luis, D5700CGR, Argentina

  • Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

    Guishan, Taoyuan, 83301, Taiwan

  • Chang Gung Memorial Hospital at Linkou

    Taipei, 10507, Taiwan

  • Charité / Pädiatrie

    Berlin, 13353, Germany

  • Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department

    Athens, 11527, Greece

  • Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department

    Athens, 11526, Greece

  • Children's Mercy Hospital Kansas City - Nephrology

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension

    Cincinnati, Ohio, 45229, United States

  • Clalit Health Services Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Clalit Health | Soroka Medical Center

    Beersheba, 8410101, Israel

  • Cleveland Clinic | Pediatric Nephrology

    Cleveland, Ohio, 14013, United States

  • Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina

    Santa Fe, Santa Fe Province, S3000, Argentina

  • Cukurova Univ. Tip. Fak. Balcali Hastanesi

    Adana, 01790, Turkey (Türkiye)

  • Dana-Dwek Children's Hospital

    Tel Aviv, 6423906, Israel

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Eccles Primary Children's Outpatient Services - Nephrology

    Salt Lake City, Utah, 84113, United States

  • Fakultní nemocnice Motol a Homolka, Pracoviště MOTOL

    Prague, Prague, 150 06, Czechia

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene

    Milan, 20122, Italy

  • Gazi Universitesi Tip Fakultesi

    Ankara, 6560, Turkey (Türkiye)

  • Great Ormond Street Hospital for Children | Clinical Research Facility

    London, Greater London, WC1N 3JH, United Kingdom

  • HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia

    Helsinki, Uusimaa, 00290, Finland

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230, Turkey (Türkiye)

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001, Israel

  • Hopital des Enfants HUG

    Geneva, 1211, Switzerland

  • Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital General de Ninos Pedro de Elizalde | Nephrology Department

    Buenos Aires, C1270, Argentina

  • Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department

    Buenos Aires, C1425EFD, Argentina

  • Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas

    São Paulo, 13034-685, Brazil

  • Hospital Pequeno Principe

    Curitiba, Paraná, 80250-060, Brazil

  • Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica

    Esplugues de Llobregat, Barcelona, 8950, Spain

  • Hospital Selayang

    Shah Alam, Selangor, 68100, Malaysia

  • Hospital Tuanku Ja'afar

    Seremban, Negeri Sembilan, 70300, Malaysia

  • Hospital Tunku Azizah

    Wilayah Persekutuan Putrajaya, Kuala Lumpur, 50300, Malaysia

  • Hospital Universitari Vall D Hebron | Nefrologia pediatrica

    Barcelona, 08035, Spain

  • Hospital Universitario 12 De Octubre | Nefrologia pediatrica

    Madrid, 28041, Spain

  • Hospital Universitario La Paz | Nefrologia pediatrica

    Madrid, 28046, Spain

  • Hospital Universitario Regional De Malaga | Nefrologia pediatrica

    Málaga, 29010, Spain

  • Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica

    Seville, 41013, Spain

  • Hospital Universiti Sains Malaysia

    Kelantan, Kelantan, 16150, Malaysia

  • Hospital of LT University of Health Sciences Kaunas Clinics

    Kaunas, Kaunas County, LT-50161, Lithuania

  • Huderf / Ukzkf

    Brussels, Brussels Capital, 1020, Belgium

  • IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene

    Genova, 16147, Italy

  • Instituto Nacional de Pediatría

    México, D.F., Mexico City, 4530, Mexico

  • Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department

    Buenos Aires, C1199ABB, Argentina

  • Instituto Veracruzano en Investigación Clinica SC

    Veracruz, 91900, Mexico

  • Instituto da Crianca e do Adolescente

    São Paulo, 05403 000, Brazil

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-730, Poland

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics

    Thessaloniki, 54642, Greece

  • Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics

    Istanbul, 34093, Turkey (Türkiye)

  • Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi

    Istanbul, 34098, Turkey (Türkiye)

  • Karolinska Universitetssjukhuset - Huddinge - Barnnjurmedicin

    Stockholm - Huddinge, 141 86, Sweden

  • Kepler Universitätsklinikum Campus IV

    Innsbruck, Tyrol, 6020, Austria

  • Kindernierenzentrum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Korea University Guro Hospital | Pediatric Nephrology

    Seoul, 08308, South Korea

  • Kyungpook National University Hospital | Pediatric Nephrology

    Daegu, 41944, South Korea

  • Lucille Packard Children's Hospital Stanford - Pediatric Nephrology

    Palo Alto, California, 94304, United States

  • Marmara University Medical Faculty | Pediatric Nephrology

    Istanbul, 34899, Turkey (Türkiye)

  • Mavani Kidney Care

    Ahmedabad, Gujarat, 380052, India

  • Medizinische Hochschule Hannover (MHH)

    Hanover, Lower Saxony, 30625, Germany

  • Medizinische Univ Graz | Kinder & Jugendheilkunde

    Graz, Styria, 8036, Austria

  • Memorial Transplant Institute - Pediatric Nephrology

    Hollywood, Florida, 33021, United States

  • Monash Children's Hospital

    Clayton, Victoria, 3168, Australia

  • NRS Medical college

    Kolkata, West Bengal, 700014, India

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100229, Taiwan

  • Nottingham Children's Hospital | Renal and Urology Unit

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

  • OHSU Doernbecher Children's Hospital - Neurology

    Portland, Oregon, 97239, United States

  • Odense Universitetshospital - HC Andersen Børne og Ungehospital

    Odense, Region of Southern Denmark / Region Syddanmark, 5000, Denmark

  • Ospedale Pediatrico Bambino Gesù - Nefrologia

    Roma, 00165, Italy

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, Baranya, 7623, Hungary

  • Pusan National University Children's Hospital | Pediatric Nephrology

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Rigshospitalet - Børn og Unge

    Copenhagen, Capital Region / Region Hovedstaden, 2100, Denmark

  • Royal Children's Hospital Melbourne

    Parkville, Victoria, 3052, Australia

  • Royal Hospital for Children | Glasgow Clinical Research Facility

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Royal Manchester Children's Hospital | Clinical Research Facility

    Manchester, Greater Manchester, M13 9WL, United Kingdom

  • Santa Casa de Misericórdia de Belo Horizonte

    São Paulo, 30150-221, Brazil

  • Seattle Children's Hospital - Nephrology

    Seattle, Washington, 98105, United States

  • Semmelweis University

    Budapest, 1083, Hungary

  • Seoul National University Bundang Hospital | Pediatric Nephrology

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital | Pediatric Nephrology

    Seoul, 03080, South Korea

  • Sitio Alfredo Chew Wong | Aguascalientes, Mexico

    Aguascalientes, Agguascalientes, 20124, Mexico

  • Skånes Universitetssjukhus - Lund - Barnnefroenheten

    Lund, Skåne County, 221 85, Sweden

  • St. John's National Academy of Health Sciences

    Bengaluru, Karnataka, 560034, India

  • Sunway Medical Centre

    Subang Jaya, Selangor, 47500, Malaysia

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6720, Hungary

  • T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu

    Ankara, 6800, Turkey (Türkiye)

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU

    Tampere, Pirkanmaa, 33521, Finland

  • The Charlotte R. Bloomberg Children's Center Building - Nephrology

    Baltimore, Maryland, 21287, United States

  • Turun yliopistollinen keskussairaala

    Turku, Southwest Finland, 20520, Finland

  • UC San Diego - Altman Clinical and Translational Research Institute (ACTRI) - Linda Vista Clinic

    San Diego, California, 92023, United States

  • UMHAT Sveti Georgi

    Plovdiv, Plovdiv Province, 4002, Bulgaria

  • UZ Gasthuisberg - Pediatric Nephrology

    Leuven, Flemish Brabant, 3000, Belgium

  • UZ Gent

    Ghent, East Flanders, 9000, Belgium

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Pediatria Ambulatória - Nefrologia

    Coimbra, 3000, Portugal

  • Unidade Local de Saúde de Santo António, E.P.E

    Porto, 4050-651, Portugal

  • Uniklinikum Salzburg - Landeskrankenhaus

    Vienna, State of Vienna, 1090, Austria

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • University General Hospital Of Ioannina-Child Health Sector

    Ioannina, 45500, Greece

  • University General Hospital of Heraklion

    Heraklion, 71110, Greece

  • University Medical Center Utrecht

    Utrecht, 3584 CX, Netherlands

  • Universitäts-Kinderspital UKBB

    Basel, Canton of Basel-City, 4031, Switzerland

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Hamburg Eppendorf (UKE)

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69115, Germany

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

    Bialystok, 15-274, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre

    Vilnius, Vilnius County, LT-08406, Lithuania

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 128 08, Czechia

  • Wilf Children's Hospital Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit

    Soweto, Gauteng, 1862, South Africa

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