Chronic Kidney DiseasePhase 3FIONANCT05196035
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
A Phase 3 study testing Finerenone (Kerendia, BAY94-8862) in people with Chronic Kidney Disease and Proteinuria, run by Bayer at 132 sites in 32 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Chronic Kidney Disease, Proteinuria
- What is being tested?
- Finerenone (Kerendia, BAY94-8862)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 132 sitesin 32 countries
- Study dates
- 28 Mar 2022to 10 May 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
132 sites in 32 countries.
132 sites in 32 countries
United States10 sites
The Charlotte R. Bloomberg Children's Center Building - Nephrology
Baltimore, Maryland, 21287
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati, Ohio, 45229
Cleveland Clinic | Pediatric Nephrology
Cleveland, Ohio, 14013
Memorial Transplant Institute - Pediatric Nephrology
Hollywood, Florida, 33021
Children's Mercy Hospital Kansas City - Nephrology
Kansas City, Missouri, 64108
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, 94304
OHSU Doernbecher Children's Hospital - Neurology
Portland, Oregon, 97239
Eccles Primary Children's Outpatient Services - Nephrology
Salt Lake City, Utah, 84113
UC San Diego - Altman Clinical and Translational Research Institute (ACTRI) - Linda Vista Clinic
San Diego, California, 92023
Seattle Children's Hospital - Nephrology
Seattle, Washington, 98105
Turkey (Türkiye)8 sites
Cukurova Univ. Tip. Fak. Balcali Hastanesi
Adana, 01790
T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu
Ankara, Aksaray, 6800
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230
Baskent Universitesi Tip Fakultesi Hastanesi
Ankara, 6490
Gazi Universitesi Tip Fakultesi
Ankara, 6560
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
Istanbul, 34093
Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
Istanbul, 34098
Marmara University Medical Faculty | Pediatric Nephrology
Istanbul, 34899
Germany7 sites
Charité / Pädiatrie
Berlin, 13353
Kindernierenzentrum Bonn
Bonn, North Rhine-Westphalia, 53127
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, 20246
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69115
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
France6 sites
CHU bordeaux - Hopital Pellegrin
Bordeaux, New Aquitaine, 33076
CHU Lyon - Hopital Femme Mere Enfant - Service de nephrologie-rhumatologie-dermatologie pediatriques
Bron, Auvergne-Rhône-Alpes, 69500
CHU Montpellier - Hopital Arnaud de Villeneuve - Service nephrologie pediatrique
Montpellier, Occitanie, 34295
APHP - Hopital Robert Debre
Paris, Île-de-France Region, 75019
CHU Strasbourg - Hopital Hautepierre - Service nephrologie pediatrique
Strasbourg, Grand Est, 67200
CHU Toulouse - Hopital des enfants
Toulouse, Occitanie, 31059
Italy6 sites
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
Bologna, Emilia-Romagna, 40138
Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
Florence, Tuscany, 50139
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
Genoa, Liguria, 16147
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
Milan, Lombardy, 20122
Ospedale Pediatrico Bambino Gesù - Nefrologia
Rome, Lazio, 00165
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
Turin, Piedmont, 10126
Spain6 sites
Hospital Universitari Vall D Hebron | Nefrologia pediatrica
Barcelona, Catalonia, 08035
Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica
Esplugues de Llobregat, Barcelona, 8950
Hospital Universitario 12 De Octubre | Nefrologia pediatrica
Madrid, 28041
Hospital Universitario La Paz | Nefrologia pediatrica
Madrid, 28046
Hospital Universitario Regional De Malaga | Nefrologia pediatrica
Málaga, 29010
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
Seville, 41013
Argentina5 sites
Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department
Buenos Aires, C1199ABB
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires, C1270
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
Buenos Aires, C1425EFD
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, D5700CGR
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
Santa Fe, Santa Fe Province, S3000
Belgium5 sites
Huderf / Ukzkf
Brussels, Brussels Capital, 1020
CU Saint-Luc/UZ St-Luc
Brussels, Brussels Capital, 1200
UZ Gent
Ghent, East Flanders, 9000
UZ Gasthuisberg - Pediatric Nephrology
Leuven, Flemish Brabant, 3000
CHC Montlégia - Pediatrics
Liège, 4000
Brazil5 sites
Hospital Pequeno Principe
Curitiba, Paraná, 80250-060
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
Ribeirão Preto, São Paulo, 14051-140
Instituto da Crianca e do Adolescente
São Paulo, 05403 000
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
São Paulo, 13034-685
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, 30150-221
Greece5 sites
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
Athens, 11526
Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
Athens, 11527
University General Hospital of Heraklion
Heraklion, 71110
University General Hospital Of Ioannina-Child Health Sector
Ioannina, 45500
Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics
Thessaloniki, 54642
Israel5 sites
Clalit Health | Soroka Medical Center
Beersheba, Southern District, 8410101
Wilf Children's Hospital Shaare Zedek Medical Center
Jerusalem, 9103102
Health Corporation of Galilee Medical Center
Nahariya, Northern District, 2210001
Clalit Health Services Schneider Children's Medical Center
Petah Tikva, Central District, 4920235
Dana-Dwek Children's Hospital
Tel Aviv, 6423906
Malaysia5 sites
Hospital Universiti Sains Malaysia
Kelantan, Kelantan, 16150
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, 70300
Hospital Selayang
Shah Alam, Selangor, 68100
Sunway Medical Centre
Subang Jaya, Selangor, 47500
Hospital Tunku Azizah
Wilayah Persekutuan Putrajaya, Kuala Lumpur, 50300
South Korea5 sites
Kyungpook National University Hospital | Pediatric Nephrology
Daegu, 41944
Seoul National University Bundang Hospital | Pediatric Nephrology
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital | Pediatric Nephrology
Seoul, 03080
Korea University Guro Hospital | Pediatric Nephrology
Seoul, 08308
Pusan National University Children's Hospital | Pediatric Nephrology
Yangsan, Gyeongsangnam-do, 50612
Taiwan5 sites
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, Taoyuan, 83301
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100229
Chang Gung Memorial Hospital at Linkou
Taipei, 10507
Taipei Veterans General Hospital
Taipei, 11217
Austria4 sites
Medizinische Univ Graz | Kinder & Jugendheilkunde
Graz, Styria, 8036
Kepler Universitätsklinikum Campus IV
Innsbruck, Tyrol, 6020
Uniklinikum Salzburg - Landeskrankenhaus
Vienna, State of Vienna, 1090
AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
Vienna, Vorarlberg, 6800
Hungary4 sites
Semmelweis University
Budapest, 1083
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, 4032
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Baranya, 7623
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, 6720
India4 sites
Mavani Kidney Care
Ahmedabad, Gujarat, 380052
St. John's National Academy of Health Sciences
Bengaluru, Karnataka, 560034
All India Institute of Medical Sciences (AIIMS) - New Delhi
Delhi, National Capital Territory of Delhi, 110029
NRS Medical college
Kolkata, West Bengal, 700014
Poland4 sites
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
Bialystok, Podlaskie Voivodeship, 15-274
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, Masovian Voivodeship, 04-730
United Kingdom4 sites
Royal Hospital for Children | Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF
Great Ormond Street Hospital for Children | Clinical Research Facility
London, Greater London, WC1N 3JH
Royal Manchester Children's Hospital | Clinical Research Facility
Manchester, Greater Manchester, M13 9WL
Nottingham Children's Hospital | Renal and Urology Unit
Nottingham, Nottinghamshire, NG7 2UH
Australia3 sites
Monash Children's Hospital
Clayton, Victoria, 3168
Royal Children's Hospital Melbourne
Parkville, Victoria, 3052
Queensland Children's Hospital
South Brisbane, Queensland, 4101
Denmark3 sites
Aarhus Universitetshospital - Børn og Unge
Aarhus N, Central Denmark Region / Region Midtjylland, 8200
Rigshospitalet - Børn og Unge
Copenhagen, Capital Region / Region Hovedstaden, 2100
Odense Universitetshospital - HC Andersen Børne og Ungehospital
Odense, Region of Southern Denmark / Region Syddanmark, 5000
Finland3 sites
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
Helsinki, Uusimaa, 00290
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
Tampere, Pirkanmaa, 33521
Turun yliopistollinen keskussairaala
Turku, Southwest Finland, 20520
Mexico3 sites
Sitio Alfredo Chew Wong | Aguascalientes, Mexico
Aguascalientes, Agguascalientes, 20124
Instituto Nacional de Pediatría
México, D.F., Mexico City, 4530
Instituto Veracruzano en Investigación Clinica SC
Veracruz, 91900
Switzerland3 sites
Universitäts-Kinderspital UKBB
Basel, Canton of Basel-City, 4031
Hopital des Enfants HUG
Geneva, 1211
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne University Hospital
Lausanne, Canton of Vaud, 1012
Canada2 sites
Alberta Children's Hospital | Nephrology Clinic
Calgary, Alberta, T3B 6A8
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, H3T 1C5
Czechia2 sites
Všeobecná fakultní nemocnice v Praze
Prague, Prague, 128 08
Fakultní nemocnice Motol a Homolka, Pracoviště MOTOL
Prague, Prague, 150 06
Lithuania2 sites
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, LT-50161
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
Vilnius, Vilnius County, LT-08406
Netherlands2 sites
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
University Medical Center Utrecht
Utrecht, 3584 CX
Portugal2 sites
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Pediatria Ambulatória - Nefrologia
Coimbra, 3000
Unidade Local de Saúde de Santo António, E.P.E
Porto, 4050-651
Sweden2 sites
Skånes Universitetssjukhus - Lund - Barnnefroenheten
Lund, Skåne County, 221 85
Karolinska Universitetssjukhuset - Huddinge - Barnnjurmedicin
Stockholm - Huddinge, 141 86
South Africa1 site
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Soweto, Gauteng, 1862
About this study
Official title: 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.
Read more
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.
- Conditions
- Chronic Kidney Disease, Proteinuria
- Being tested
- Finerenone (Kerendia, BAY94-8862), Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (Kerendia, BAY94-8862)Drug
Finerenone in different doses, treatment duration will be 180±7 days
PlaceboDrug
Placebo to finerenone, treatment duration will be 180±7 days
| Study group | Role | What they receive |
|---|---|---|
| Finerenone (Kerendia, BAY94-8862) | Experimental | Participants will receive finerenone treatment. Receives: Drug: Finerenone (Kerendia, BAY94-8862) |
| Placebo | Placebo comparator | Participants will receive placebo to finerenone. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Urinary protein-to-creatinine ratio (UPCR) reduction from baseline to day 180+/-7
Percent change from baseline to day 180±7 in UPCR will be calculated.
Measured: From baseline to day 180+/-7
Secondary outcomes (10)
Number participants with treatment emergent adverse events (TEAEs）
Below sub-categories will be considered:
- Serious Treatment Emergent Adverse Events (TEAEs)
- TEAEs and serious TEAEs leading to discontinuation of treatment
- Study drug related TEAEs and serious TEAEs
- TEAEs categorized by severity (mild, moderate, severe)
- TEAEs by maximum intensity
- Number of participants hospitalized with hyperkalemia,
- Number of participants discontinuing due to hyperkalemia,
- Number of participants with hospitalization for worsening of renal function
- Number of participants discontinuing due to worsening of renal function
Measured: From the start of study intervention to last study intervention + 3 days (up to 190 days)
Change in serum potassium levels from baseline to day 180±7
Measured: From baseline to day 180±7
Change in serum creatinine from baseline to day 180±7
Measured: From baseline to day 180±7
Change in eGFR from baseline to day 180±7
Estimated glomerular filtration rate (eGFR)
Measured: From baseline to day 180±7
Change in systolic blood pressure from baseline to day 180±7
Measured: From baseline to day 180±7
UPCR reduction of at least 30% from baseline to day 180+/-7
Proportion of participants at day 180+/-7 with a >=30% reduction in PUCR compared to baseline
Measured: From baseline to day 180±7
Change in UACR from baseline to day 180±7
Urinary albumin-to-creatinine ratio (UACR)
Measured: From baseline to day 180±7
Pharmacokinetics (PK) finerenone Cmax, md
Maximum observed finerenone concentration in plasma after multiple doses.
Measured: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Pharmacokinetics (PK) finerenone AUCτ,md
Area under the curve for finerenone concentration in plasma after multiple doses.
Measured: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Taste and texture questionnaire of the pediatric formulation
Measured: On day 30±3 and day 180±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start28 Mar 2022
- Primary completion10 Apr 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196035
- Sponsor's protocol ID
- 19920
- Other IDs
- 2023-504884-17-00, 2021-002071-19, 2023
- Acronym
- FIONA
- Status last verified
- 2 Sep 2026
- First submitted
- 7 Jan 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Schaefer F, Montini G, Kang HG, Walle JV, Zaritsky J, Schreuder MF, Litwin M, Scalise A, Scott H, Potts J, Iveli P, Breitenstein S, Warady BA. Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies. Trials. 2024 Mar 21;25(1):203. doi: 10.1186/s13063-024-08021-z.
PubMed 38509517