Trial Condition(s):
Chronic Kidney Disease, Proteinuria
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 (FIONA)
Bayer Identifier:
19920
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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:
-- 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 D0Exclusion 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Austria | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Australia | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Belgium | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Canada | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Switzerland | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, China | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Czech Republic | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Germany | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Denmark | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Spain | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Finland | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, France | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, United Kingdom | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Greece | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Hungary | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Israel | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Italy | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, South Korea | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Lithuania | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Netherlands | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Poland | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Portugal | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Sweden | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Many Locations Many Locations, Turkey | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Universitätsklinikum Essen Essen, Germany, 45147 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Universitätsklinikum Münster (UKM) Münster, Germany, 48149 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Great Ormond Street Hospital for Children London, United Kingdom, WC1N 3JH | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Queens Medical Centre Nottingham, United Kingdom, NG7 2UH | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Royal Manchester Children's Hospital Manchester, United Kingdom, M13 9WL | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Royal Hospital for Children Glasgow, United Kingdom, G51 4TF | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Children's Mercy Hospital & Clinics Kansas City, United States, 64108-9898 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Oregon Health and Science Univ | Doernbecher Childrens Hosp Portland, United States, 97239 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hôpital des Enfants TOULOUSE Cedex 9, France, 31059 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hôpital Pellegrin - Bordeaux BORDEAUX cedex, France, 33076 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations CHU de Lyon - Hopital Femme Mère Enfant BRON, France, 69677 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hôpital Arnaud de Villeneuve - Montpellier MONTPELLIER, France, 34059 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations CHU STRASBOURG - Hôpital de Hautepierre Strasbourg, France, 67200 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations HOPITAL ROBERT DEBRE Paris, France, 75019 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Instytut "Pomnik – Centrum Zdrowia Dziecka" Warszawa, Poland, 04-730 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa Bialystok, Poland, 15-274 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations IRCCS Istituto Giannina Gaslini Genova, Italy, 16147 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations IRCCS Ospedale Pediatrico Bambino Gesù Roma, Italy, 00165 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Virgen del Rocio University Hospital | Pediatric Nephrology Unit Sevilla, Spain, 41013 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08023 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hospital de Sant Joan de Déu Esplugues de LLobregat, Spain, 8950 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hospital Regional de Málaga Málaga, Spain, 29010 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC) Madrid, Spain, 28041 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations UZ Gasthuisberg - Pediatric Nephrology Leuven, Belgium, 3000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations HUDERF / UKZKF BRUXELLES - BRUSSEL, Belgium, 1020 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Universitair Medisch Centrum Groningen GRONINGEN, Netherlands, 9713 GZ | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations University Medical Center Utrecht UTRECHT, Netherlands, 3584 CX | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Karolinska University Hospital Stockholm, Sweden, 141 86 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Uppsala University Hospital Uppsala, Sweden, 751 85 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Skåne University Hospital Lund, Sweden, 221 85 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Århus N, Denmark, 8200 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Odense, HC Andersen Odense C, Denmark, 5000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Rigshospitalet, Dept Pediatrics & Adelescent Med. Copenhagen, Denmark, 2100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 12808 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Fakultni nemocnice v Motole Praha 5, Czech Republic, 150 06 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Clalit Health Services Schneider Children's Medical Center Petach Tikva, Israel, 4920235 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Dana-Dwek Children’s Hospital Tel Aviv, Israel, 6423906 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Wilf Children's Hospital Shaare Zedek Medical Center Jerusalem, Israel, 9103102 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Soroka University Medical Center Beer Sheva, Israel, 8410101 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Monash Children's Hospital Clayton, Australia, 3168 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Queensland Children’s Hospital South Brisbane, Australia, 4101 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Royal Children's Hospital Melbourne Parkville, Australia, 3052 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4050-651 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie Wien, Austria, 1090 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Medizinische Univ Graz | Kinder & Jugendheilkunde Graz, Austria, 8036 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Kepler Universitätsklinikum Campus IV Linz, Austria, 4020 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Uniklinikum Salzburg - Landeskrankenhaus Salzburg, Austria, 5020 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6720 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1083 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7623 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Gazi Universitesi Tip Fakultesi Ankara, Turkey, 06560 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hacettepe Universitesi Tip Fakultesi Ankara, Turkey, 06100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali Istanbul, Turkey, 34098 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital Ankara, Turkey, 06800 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi Istanbul, Turkey, 34899 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Baskent Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 06490 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Children's Hospital of Athens P&A Kyriakou Athens, Greece | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations University General Hospital of Heraklion Crete, Greece, 71500 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Ioannina University General Hospital Ioannina, Greece, 45500 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 3080 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Kyungpook National University Hospital Daegu, South Korea, 41944 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Pusan National University Yangsan Hospital Yangsan-si, South Korea, 50612 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Seoul National University Bundang Hospital Seongnam-si, South Korea, 13620 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Vilnius University Hospital Santaros Klinikos Children‘s Hospital Paediatrics Centre Vilnius, Lithuania, LT-08406 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hospital of LT University of Health Sciences Kaunas Clinics Kaunas, Lithuania, LT-50161 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne, Switzerland, 1011 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations HUS Uusi lastensairaala Helsinki, Finland, 00290 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Pediatric Early Phase Trial Unit, Tampere University Hospita Tampere, Finland, 33521 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, 20520 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Cincinnati Children's Hospital and Medical Center Cincinnati, United States, 45229 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Stanford Medicine Palo Alto, United States, 94304 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations CHU Sainte-Justine Montreal, Canada, H3T 1C5 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Univ of Texas Health Science Center | Nephrology Res Dept San Antonio, United States, 78207 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Seattle Children's Hospital Seattle, United States, 98105 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Universitäts-Kinderspital UKBB Basel, Switzerland, 4056 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Cleveland Clinic | Pediatric Nephrology Cleveland, United States, 14013 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Alberta Children's Hospital, University of Calgary Calgary, Canada, T3B 6A8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Instytut Centrum Zdrowia Matki Polki Lodz, Poland, 93-338 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Kindernierenzentrum Bonn Bonn, Germany, 53127 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Charité / Pädiatrie Berlin, Germany, 13353 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Centro de Rehabilitacion Cardiovascular | San Luis, Argentina San Luis, Argentina, D5700CGR | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hospital de Niños "Ricardo Gutiérrez" Buenos Aires, Argentina, C1425EFD | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina Santa Fe, Argentina, S3000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hospital Italiano Buenos Aires Buenos Aires, Argentina, C1199ABB | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hospital General de Niños Pedro de Elizalde Ciudad de Buenos Aires, Argentina, C1270AAN | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics Istanbul, Turkey, 34093 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations University of Iowa Iowa City, United States, 52242 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Primary Children’s Hospital Salt Lake City, United States, 84112 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations South Broward Hosp. District dba Memorial Healthcare System Hollywood, United States, 33021 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations AGIA SOFIA Children's Hospital Athens, Greece, 11527 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Phoenix Children's Hospital | Main - Transplant Department Phoenix, United States, 85016 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Children's Hospital of Philadelphia Philadelphia, United States, 19104 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Korea University Guro Hospital Seoul, South Korea, 08308 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Hopital des Enfants HUG Geneva, Switzerland, 1211 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob Baltimore, United States, 21287 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations CHC Montlégia - Pediatrics Liège, Belgium, 4000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-214 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Locations Cukurova Univ. Tip. Fak. Balcali Hastanesi Adana, Turkey, 01790 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7Proportion of participants at day 180±7 with a >=30% reduction in UPCR compared to baseline.Timeframe: From baseline to day 180±7
Secondary Outcome
- Number participants with treatment emergent adverse events (TEAEs）Below sub-categories will be considered: a. Serious Treatment Emergent Adverse Events (TEAEs) b. TEAEs and serious TEAEs leading to discontinuation of treatment c. Study drug related TEAEs and serious TEAEs d. TEAEs categorized by severity (mild, moderate, severe) e. TEAEs by maximum intensity f. Number of participants hospitalized with hyperkalemia, g. Number of participants discontinuing due to hyperkalemia, h. Number of participants with hospitalization for worsening of renal function i. Number of participants discontinuing due to worsening of renal functionTimeframe: 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±7Timeframe: From baseline to day 180±7
- Change in serum creatinine from baseline to day 180±7Timeframe: From baseline to day 180±7
- Change in eGFR from baseline to day 180±7Estimated glomerular filtration rate (eGFR)Timeframe: From baseline to day 180±7
- Change in systolic blood pressure from baseline to day 180±7Timeframe: From baseline to day 180±7
- Mean reduction from baseline to day 180±7 in UPCRPercent change from baseline to day 180±7 in UPCR will be calculated.Timeframe: From baseline to day 180±7
- Change in UACR from baseline to day 180±7Urinary albumin-to-creatinine ratio (UACR)Timeframe: From baseline to day 180±7
- Pharmacokinetics (PK) finerenone Cmax, mdMaximum observed finerenone concentration in plasma after multiple doses.Timeframe: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
- Pharmacokinetics (PK) finerenone AUCτ,mdArea under the curve for finerenone concentration in plasma after multiple doses.Timeframe: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
- Taste and texture questionnaire of the pediatric formulationTimeframe: On day 30±3 and day 180±7
Additional Information
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