A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria
Launched by BAYER · Jan 7, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment called finerenone for children with chronic kidney disease (CKD) and proteinuria, which is when the kidneys leak too much protein into the urine. The study aims to find out if finerenone, when taken alongside standard medications called ACE inhibitors or angiotensin receptor blockers (ARBs), can help improve kidney function and reduce protein levels in urine better than a placebo, which looks like medicine but has no active ingredients. The trial is open to children aged 6 months to less than 18 years who have been diagnosed with CKD and meet specific health criteria.
Participants in the trial will receive regular check-ups over about 180 days, including blood and urine tests to monitor their kidney health and overall well-being. They will also have their blood pressure and heart health checked. Parents or guardians will play a key role in answering questions about the child's health and any side effects experienced during the study. The trial is currently recruiting participants, and it’s important for families to discuss with their healthcare provider if they think their child might be eligible to join this important research effort.
Gender
ALL
Eligibility criteria
- 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
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Iowa City, Iowa, United States
Paris, , France
Washington, District Of Columbia, United States
Columbus, Ohio, United States
Phoenix, Arizona, United States
Utrecht, , Netherlands
Columbus, Ohio, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Westmead, New South Wales, Australia
South Brisbane, Queensland, Australia
Gent, , Belgium
Uppsala, , Sweden
Madrid, , Spain
Taipei, , Taiwan
Boston, Massachusetts, United States
Leuven, , Belgium
Nottingham, , United Kingdom
Groningen, , Netherlands
Toulouse Cedex 9, , France
Stockholm, , Sweden
Parkville, Victoria, Australia
Cincinnati, Ohio, United States
Erlangen, Bayern, Germany
Lodz, , Poland
Praha 2, , Czechia
Montreal, Quebec, Canada
Seremban, Negeri Sembilan, Malaysia
Hamilton, Ontario, Canada
Nijmegen, , Netherlands
Chandigarh, , India
Gdansk, , Poland
Gdansk, , Poland
Birmingham, West Midlands, United Kingdom
Praha 5, , Czechia
Glasgow, , United Kingdom
Washington, District Of Columbia, United States
Ankara, , Turkey
Hamburg, , Germany
Manchester, , United Kingdom
Torino, , Italy
Münster, , Germany
Budapest, , Hungary
Heidelberg, Baden Württemberg, Germany
Belo Horizonte, Minas Gerais, Brazil
London, , United Kingdom
Thessaloniki, , Greece
Essen, Nordrhein Westfalen, Germany
Lund, , Sweden
Pecs, , Hungary
Debrecen, , Hungary
Heraklion, , Greece
Lausanne, Vaud, Switzerland
Heidelberg, , Germany
Turku, , Finland
Multiple Locations, , Korea, Republic Of
Toronto, Ontario, Canada
Bologna, Emilia Romagna, Italy
Strasbourg, , France
Bruxelles Brussel, , Belgium
Krakow, , Poland
Ankara, , Turkey
Multiple Locations, , Sweden
Kelantan, , Malaysia
Praha 2, , Czechia
Warszawa, , Poland
Multiple Locations, , Germany
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Turku, , Finland
Montpellier, , France
Milano, Lombardia, Italy
Esplugues De Llobregat, Barcelona, Spain
Barcelona, , Spain
Beer Sheva, , Israel
Seongnam Si, Gyeonggido, Korea, Republic Of
Plovdiv, , Bulgaria
Hannover, Niedersachsen, Germany
Münster, Nordrhein Westfalen, Germany
Braga, , Portugal
Istanbul, , Turkey
Boston, Massachusetts, United States
Copenhagen, , Denmark
Petach Tikva, , Israel
Multiple Locations, , Finland
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Multiple Locations, , Greece
Málaga, , Spain
Helsinki, , Finland
Curitiba, Parana, Brazil
Thessaloniki, , Greece
Bonn, , Germany
Multiple Locations, , United Kingdom
Multiple Locations, , China
Multiple Locations, , France
Multiple Locations, , Italy
Multiple Locations, , Belgium
Multiple Locations, , Canada
Multiple Locations, , Spain
La Jolla, California, United States
Wroclaw, , Poland
Multiple Locations, , Austria
Multiple Locations, , Denmark
Multiple Locations, , Netherlands
Multiple Locations, , Turkey
Clayton, Victoria, Australia
Multiple Locations, , Switzerland
Palo Alto, California, United States
Salzburg, , Austria
Linz, Oberösterreich, Austria
Multiple Locations, , Portugal
Multiple Locations, , Australia
Multiple Locations, , Czechia
Multiple Locations, , Hungary
Multiple Locations, , Israel
Roma, Lazio, Italy
Multiple Locations, , Poland
Ankara, , Turkey
Genova, Liguria, Italy
Klaipeda, , Lithuania
Ankara, , Turkey
Taipei, , Taiwan
Salt Lake City, Utah, United States
Kaunas, , Lithuania
Ioannina, , Greece
Nahariya, , Israel
Szeged, , Hungary
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Bialystok, , Poland
Baltimore, Maryland, United States
Lisboa, , Portugal
Kansas City, Missouri, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
San Antonio, Texas, United States
Graz, Steiermark, Austria
Wien, , Austria
Bruxelles Brussel, , Belgium
Calgary, Alberta, Canada
Odense C, , Denmark
århus N, , Denmark
Tampere, , Finland
Bordeaux Cedex, , France
Bron, , France
Heidelberg, Baden Württemberg, Germany
Athens, , Greece
Crete, , Greece
Jerusalem, , Israel
Tel Aviv, , Israel
Daegu, Daegu Gwang''Yeogsi, Korea, Republic Of
Yangsan Si, Gyeongsangnamdo, Korea, Republic Of
Multiple Locations, , Lithuania
Vilnius, , Lithuania
Warszawa, , Poland
Porto, , Portugal
Madrid, , Spain
Sevilla, , Spain
Basel, Basel Stadt, Switzerland
Istanbul, , Turkey
Bonn, Nordrhein Westfalen, Germany
Berlin, , Germany
Aguascalientes, , Mexico
Barcelona, , Spain
Barcelona, , Spain
Köln, Nordrhein Westfalen, Germany
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Ankara, , Turkey
Ankara, , Turkey
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Vilnius, , Lithuania
Kolkata, , India
San Luis, , Argentina
Ribeirão Preto/Sp, Sao Paulo, Brazil
Leuven, , Belgium
Hollywood, Florida, United States
Ciudad De Buenos Aires, , Argentina
Santa Fe, , Argentina
Athens, , Greece
Istanbul, , Turkey
Liège, , Belgium
Geneva, , Switzerland
Phoenix, Arizona, United States
Esplugues De Llobregat, Barcelona, Spain
Sevilla, , Spain
Adana, , Turkey
Braga, , Portugal
Ankara, , Turkey
Ankara, , Turkey
Atlanta, Georgia, United States
Strasbourg, , France
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Kaohsiung City, , Taiwan
Beer Sheva, , Israel
Istanbul, , Turkey
San Luis, , Argentina
Ioannina, , Greece
Shah Alam, Selangor, Malaysia
Roma, Lazio, Italy
Baltimore, Maryland, United States
Cincinnati, Ohio, United States
Ciudad Autonoma De Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Santa Fe, , Argentina
Buenos Aires, , Argentina
Helsinki, , Finland
Tampere, , Finland
Athens, , Greece
Genova, Liguria, Italy
Firenze, , Italy
Missing, Lisboa, Portugal
Porto, , Portugal
Barcelona, , Spain
Málaga, , Spain
Ankara, , Turkey
Istanbul, , Turkey
Tainan, Tnn, Taiwan
Lisboa, , Portugal
Copenhagen, , Denmark
århus N, , Denmark
São Paulo, Sao Paulo, Brazil
Subang Jaya, Selangor, Malaysia
Odense C, , Denmark
Bologna, Emilia Romagna, Italy
Hamilton, Ontario, Canada
Athens, , Greece
Roma, Lazio, Italy
Genova, Liguria, Italy
Milano, Lombardia, Italy
Firenze, , Italy
Torino, , Italy
Johannesburg, , South Africa
Torino, , Italy
Coimbra, , Portugal
Sao Paulo, Sp, Brazil
Sao Paulo, , Brazil
Bangalore, , India
Ciudad De Mexico, Distrito Federal, Mexico
México D.F., Distrito Federal, Mexico
México, D.F., Distrito Federal, Mexico
Ixtapaluca, Estado De Mexico, Mexico
Lund, , Sweden
Washington, District Of Columbia, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Philadelphia, Pennsylvania, United States
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Delhi, , India
Heraklion, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Calgary, Alberta, Canada
Praha 2, , Czechia
Athens, , Greece
Athens, , Greece
Palo Alto, California, United States
Buenos Aires, , Argentina
Montpellier, , France
Columbus, Ohio, United States
Wilayah Persekutuan, Kuala Lumpur, Malaysia
Aguascalientes, Agguascalientes, Mexico
Ciudad De Mexico, Distrito Federal, Mexico
Soweto, Gauteng, South Africa
Guishan, , Taiwan
Bordeaux Cedex, , France
Portland, Oregon, United States
Athens, , Greece
Hollywood, Florida, United States
Seattle, Washington, United States
Málaga, , Spain
Sevilla, , Spain
Lausanne, Vaud, Switzerland
Linz, , Austria
San Luis, Provincia De San Luis, Argentina
Santa Fe, Provincia De Santa Fe, Argentina
Los Angeles, California, United States
Ahmedabad, , India
Nuevo León, Monterrey, Mexico
Taipei, , Taiwan
Glasgow, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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