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
- Conditions
- Chronic Kidney DiseaseProteinuria
- Interventions
- Drug: Placebo
- Registration Number
- NCT05196035
- Lead Sponsor
- Bayer
- Brief Summary
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, is expected to help control RAAS overactivation together with an ACEI or ARB.
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.
The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.
To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests.
This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take:
* either finerenone or the placebo, in addition to
* either ACEI or ARB, whichever they take as part of their normal treatment
Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will:
* have their blood pressure, heart rate, temperature, height and weight measured
* have blood and urine samples taken
* have physical examinations
* have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)
* answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer
* answer questions about how they are feeling, or have their parents or guardians answer
* answer question about how they like the study medication, or have their parents or guardians answer
The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The doctors will check the participants' health about 30 days after the participants take their last treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 219
-
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:
- no increase or decrease in eGFR ≥ 15% for children ≥1 year or
- no increase or decrease in creatinine ≥ 0.10 mg/dL for children <1 year
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Finerenone (Kerendia, BAY94-8862) Finerenone (Kerendia, BAY94-8862) Participants will receive finerenone treatment. Placebo Placebo Participants will receive placebo to finerenone.
- Primary Outcome Measures
Name Time Method Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7 From baseline to day 180±7 Proportion of participants at day 180±7 with a \>=30% reduction in UPCR compared to baseline.
- Secondary Outcome Measures
Name Time Method Change in systolic blood pressure from baseline to day 180±7 From baseline to day 180±7 Mean reduction from baseline to day 180±7 in UPCR From baseline to day 180±7 Percent change from baseline to day 180±7 in UPCR will be calculated.
Pharmacokinetics (PK) finerenone Cmax, md Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7 Maximum observed finerenone concentration in plasma after multiple doses.
Number participants with treatment emergent adverse events (TEAEs） From the start of study intervention to last study intervention + 3 days (up to 190 days) Below sub-categories will be considered:
1. Serious Treatment Emergent Adverse Events (TEAEs)
2. TEAEs and serious TEAEs leading to discontinuation of treatment
3. Study drug related TEAEs and serious TEAEs
4. TEAEs categorized by severity (mild, moderate, severe)
5. TEAEs by maximum intensity
6. Number of participants hospitalized with hyperkalemia,
7. Number of participants discontinuing due to hyperkalemia,
8. Number of participants with hospitalization for worsening of renal function
9. Number of participants discontinuing due to worsening of renal functionChange in eGFR from baseline to day 180±7 From baseline to day 180±7 Estimated glomerular filtration rate (eGFR)
Taste and texture questionnaire of the pediatric formulation On day 30±3 and day 180±7 Pharmacokinetics (PK) finerenone AUCτ,md Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7 Area under the curve for finerenone concentration in plasma after multiple doses.
Change in serum potassium levels from baseline to day 180±7 From baseline to day 180±7 Change in serum creatinine from baseline to day 180±7 From baseline to day 180±7 Change in UACR from baseline to day 180±7 From baseline to day 180±7 Urinary albumin-to-creatinine ratio (UACR)
Trial Locations
- Locations (156)
Rigshospitalet - Børn og Unge
🇩🇰Copenhagen, Denmark
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)
🇪🇸Madrid, Spain
Hospital la Paz
🇪🇸Madrid, Spain
Children's Hospital of Philadelphia - Nephrology
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Texas Health Science Center | Nephrology Res Dept
🇺🇸San Antonio, Texas, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
🇦🇷San Luis, Provincia De San Luis, Argentina
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
🇦🇷Santa Fe, Provincia De Santa Fe, Argentina
Hospital de Pediatría Juan P. Garrahan
🇦🇷Buenos Aires, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
🇦🇷Buenos Aires, Argentina
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Queensland Children's Hospital
🇦🇺South Brisbane, Queensland, Australia
Monash Children's Hospital
🇦🇺Clayton, Victoria, Australia
Royal Children's Hospital Melbourne
🇦🇺Parkville, Victoria, Australia
Kepler Universitätsklinikum Campus IV
🇦🇹Linz, Oberösterreich, Austria
Medizinische Univ Graz | Kinder & Jugendheilkunde
🇦🇹Graz, Steiermark, Austria
Uniklinikum Salzburg - Landeskrankenhaus
🇦🇹Salzburg, Austria
AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
🇦🇹Wien, Austria
Huderf / Ukzkf
🇧🇪Bruxelles - Brussel, Belgium
CU Saint-Luc/UZ St-Luc
🇧🇪Bruxelles - Brussel, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ Gasthuisberg - Pediatric Nephrology
🇧🇪Leuven, Belgium
CHC Montlégia - Pediatrics
🇧🇪Liège, Belgium
Santa Casa de Misericórdia de Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Hospital Pequeno Principe
🇧🇷Curitiba, Parana, Brazil
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
🇧🇷Ribeirão Preto/SP, Sao Paulo, Brazil
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
🇧🇷Sao Paulo, SP, Brazil
Instituto da Crianca e do Adolescente
🇧🇷Sao Paulo, Brazil
UMHAT Sveti Georgi
🇧🇬Plovdiv, Bulgaria
SHATPD "Prof. Ivan Mitev"
🇧🇬Sofia, Bulgaria
MHAT prof. Stoyan Kirkovitch AD
🇧🇬Stara Zagora, Bulgaria
Alberta Children's Hospital - Nephrology Clinic
🇨🇦Calgary, Alberta, Canada
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
The Hospital for Sick Children (SickKids)
🇨🇦Toronto, Ontario, Canada
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Všeobecná fakultní nemocnice v Praze
🇨🇿Praha 2, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Odense Universitetshospital - HC Andersen Børne og Ungehospital
🇩🇰Odense C, Denmark
Aarhus Universitetshospital - Børn og Unge
🇩🇰Århus N, Denmark
Helsinki University Hospital | Children's Hospital - Clinical Trial Unit, Nephrology Department
🇫🇮Helsinki, Finland
Tays Service Centre | Tampere University Hospital - Pediatric Early Phase Clinical Trials Unit
🇫🇮Tampere, Finland
Turun yliopistollinen keskussairaala
🇫🇮Turku, Finland
Hôpital Pellegrin - Bordeaux
🇫🇷BORDEAUX cedex, France
CHU de Lyon - Hopital Femme Mère Enfant
🇫🇷Bron, France
Hopital Arnaud de Villeneuve CHU Montpellier
🇫🇷Montpellier, France
Hopital Robert Debre
🇫🇷Paris, France
CHU Strasbourg - Hopital Hautepierre
🇫🇷Strasbourg, France
Hôpital des Enfants
🇫🇷TOULOUSE Cedex 9, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Niedersachsen, Germany
Kindernierenzentrum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Muenster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Charité / Pädiatrie
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
🇩🇪Hamburg, Germany
Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
🇬🇷Athens, Greece
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
🇬🇷Athens, Greece
University General Hospital of Heraklion - Department of Paediatrics
🇬🇷Heraklion, Greece
Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit
🇬🇷Ioannina, Greece
Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit'
🇬🇷Thessaloniki, Greece
Semmelweis University
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
St. John's National Academy of Health Sciences
🇮🇳Bangalore, India
All India Institute of Medical Sciences (AIIMS) - New Delhi
🇮🇳Delhi, India
NRS Medical college
🇮🇳Kolkata, India
Clalit Health | Soroka Medical Center - Internal Medicine Department
🇮🇱Beer Sheva, Israel
Wilf Children's Hospital Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Health Corporation of Galilee Medical Center
🇮🇱Nahariya, Israel
Clalit Health Services Schneider Children's Medical Center
🇮🇱Petach Tikva, Israel
Dana-Dwek Children's Hospital
🇮🇱Tel Aviv, Israel
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
🇮🇹Bologna, Emilia-Romagna, Italy
Ospedale Pediatrico Bambino Gesù - Nefrologia
🇮🇹Roma, Lazio, Italy
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
🇮🇹Genova, Liguria, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
🇮🇹Firenze, Italy
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
🇮🇹Torino, Italy
Kyungpook National University Hospital
🇰🇷Daegu, Daegu Gwang''yeogsi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital of LT University of Health Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
Klaipeda Children's Hospital
🇱🇹Klaipeda, Lithuania
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
🇱🇹Vilnius, Lithuania
Hospital Tunku Azizah
🇲🇾Wilayah Persekutuan, Kuala Lumpur, Malaysia
Hospital Tuanku Ja'afar
🇲🇾Seremban, Negeri Sembilan, Malaysia
Hospital Selayang
🇲🇾Shah Alam, Selangor, Malaysia
Sunway Medical Centre
🇲🇾Subang Jaya, Selangor, Malaysia
Hospital Universiti Sains Malaysia
🇲🇾Kelantan, Malaysia
Sitio Alfredo Chew Wong | Aguascalientes, Mexico
🇲🇽Aguascalientes, Agguascalientes, Mexico
Instituto Veracruzano en Investigación Clinica SC
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Hospital Infantil de México "Dr. Federico Gómez"
🇲🇽México D.F., Distrito Federal, Mexico
Instituto Nacional de Pediatría
🇲🇽México, D.F., Distrito Federal, Mexico
Hospital Regional de Alta Especialidad Ixtapaluca
🇲🇽Ixtapaluca, Estado De Mexico, Mexico
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Universitair Medisch Centrum St. Radboud
🇳🇱Nijmegen, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
🇵🇱Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
🇵🇱Krakow, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego
🇵🇱Warszawa, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
🇵🇱Warszawa, Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
🇵🇱Wroclaw, Poland
Hospital Santa Maria | Centro de Investigacao Clinica
🇵🇹Missing, Lisboa, Portugal
Centro Clinico Academico Braga | Braga, Portugal
🇵🇹Braga, Portugal
Hospital Pediátrico de Coimbra I ULS Coimbra
🇵🇹Coimbra, Portugal
Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica
🇵🇹Porto, Portugal
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
🇿🇦Soweto, Gauteng, South Africa
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Sant Joan de Déu
🇪🇸Barcelona, Spain
University Hospital of Malaga | Unidad de Gestion Clinica de Pediatria
🇪🇸Málaga, Spain
Virgen del Rocio University Hospital | Pediatric Nephrology Unit
🇪🇸Sevilla, Spain
Skånes Universitetssjukhus Lund - Barnnefroenheten
🇸🇪Lund, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Universitäts-Kinderspital UKBB
🇨🇭Basel, Basel-Stadt, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Vaud, Switzerland
Hopital des Enfants HUG
🇨🇭Geneva, Switzerland
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
🇨🇳Guishan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Cukurova Univ. Tip. Fak. Balcali Hastanesi
🇹🇷Adana, Turkey
Hacettepe Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Baskent Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Gazi Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
🇹🇷Ankara, Turkey
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
🇹🇷Istanbul, Turkey
Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
🇹🇷Istanbul, Turkey
Marmara University Medical Faculty | Pediatric Nephrology
🇹🇷Istanbul, Turkey
Birmingham Children's Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
Royal Hospital for Children
🇬🇧Glasgow, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
Queens Medical Centre
🇬🇧Nottingham, United Kingdom
Phoenix Children's Hospital | Main - Transplant Department
🇺🇸Phoenix, Arizona, United States
University of California San Diego (UCSD)
🇺🇸La Jolla, California, United States
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
🇺🇸Palo Alto, California, United States
Children's National Medical Center - Nephrology
🇺🇸Washington, District of Columbia, United States
South Broward Hosp. District dba Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
🇺🇸Atlanta, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
The Charlotte R. Bloomberg Children's Center Building - Nephrology
🇺🇸Baltimore, Maryland, United States
Boston Children's Hospital - Main Campus - Nephrology
🇺🇸Boston, Massachusetts, United States
Children's Mercy Hospital Kansas City - Nephrology
🇺🇸Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic | Pediatric Nephrology
🇺🇸Cleveland, Ohio, United States
Nationwide Children's Hospital - Nephrology
🇺🇸Columbus, Ohio, United States
Oregon Health and Science Univ | Doernbecher Childrens Hosp
🇺🇸Portland, Oregon, United States