Trial Condition(s):

Chronic Kidney Disease, Proteinuria, Children

A study to learn more about how safe the study treatment finerenone is in long-term use when taken with an ACE inhibitor or angiotensin receptor blocker over 18 months of use in children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria (FIONA OLE)

Bayer Identifier:

20186

ClinicalTrials.gov Identifier:

NCT05457283

EudraCT Number:

2021-002905-89

EU CT Number:

2023-504885-50-00

Recruiting

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 help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). 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 impair the ability of the kidneys to work 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 how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term.

To see how safe the treatment is, the study team will collect information on medical problems which are also known as “treatment emergent adverse events” (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study.

The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants’ urine and benefit kidney function when taken with standard of care.

To see how the treatment works, the study team will collect participants’ urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function.

The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years.

The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone.

In the visit, the study team 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 guardian’s answer
•    answer questions about how they are feeling, or have their parents or guardian’s answer
•    answer question about how they like the study medication, or have their parents or guardian’s 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 ≥1 year to 18 years of age, at the time of signing the informed consent/assent.
 - Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
 - Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as
    -- CKD stages 1-3 (estimated glomerular filtration rate [eGFR] ≥30 mL/min/1.73m^2) for children ≥1 year to <19 years of age at FIONA EoT and at Visit 1
 - 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 (BP) management, unchanged for at least 30 days prior to Visit 1.
 - K+ ≤5.0 mmol/L for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol/L for children <2 years of age at both FIONA EoT and Visit 1
 - Participants who have reached legal age of consent: Capable of giving signed informed consent.
 - Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
Exclusion Criteria
- Planned urological surgery expected to influence renal function
 - Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
 - Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.
 - Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants <18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) <90 mmHg in participants ≥18 years at Visit 1.
 - Known hypersensitivity to the study treatment (active substance or excipients)
 - Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
 - Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
 - Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)
 - Concomitant therapy with both ACEI and ARBs together
 - Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers 
 - Previous assignment to treatment during this study
 - Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
 - Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study. 
 - Pregnant or breastfeeding or intention to become pregnant during the study

Trial Summary

Enrollment Goal
100
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Many Locations

Many Locations, Italy

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Recruiting
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Many Locations, Austria

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Many Locations, Australia

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Many Locations, Belgium

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Many Locations, Canada

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Many Locations, Switzerland

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Many Locations

Many Locations, Czech Republic

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Many Locations

Many Locations, Germany

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Many Locations

Many Locations, Denmark

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Many Locations, Spain

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Many Locations, Finland

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Many Locations

Many Locations, France

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Many Locations

Many Locations, United Kingdom

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Many Locations

Many Locations, Greece

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Many Locations

Many Locations, Hungary

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Many Locations

Many Locations, Israel

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Many Locations

Many Locations, South Korea

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Many Locations

Many Locations, Lithuania

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Many Locations

Many Locations, Netherlands

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Many Locations

Many Locations, Poland

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Many Locations

Many Locations, Portugal

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Many Locations, Sweden

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Many Locations, Turkey

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Many Locations, Argentina

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Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

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Not yet recruiting
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Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

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Not yet recruiting
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Medizinische Hochschule Hannover (MHH)

Hannover, Germany, 30625

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Not yet recruiting
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Universitätsklinikum Essen

Essen, Germany, 45147

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Recruiting
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Universitätsklinikum Münster (UKM)

Münster, Germany, 48149

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Not yet recruiting
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Charité / Pädiatrie

Berlin, Germany, 13353

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Not yet recruiting
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Great Ormond Street Hospital for Children

London, United Kingdom, WC1N 3JH

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Recruiting
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Queens Medical Centre

Nottingham, United Kingdom, NG7 2UH

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Not yet recruiting
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Royal Manchester Children's Hospital

Manchester, United Kingdom, M13 9WL

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Recruiting
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Royal Hospital for Children

Glasgow, United Kingdom, G3 8SJ

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Recruiting
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Univ of Texas Health Science Center | Nephrology Res Dept

San Antonio, United States, 78207

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Not yet recruiting
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Cincinnati Children's Hospital and Medical Center

Cincinnati, United States, 45229-3039

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Not yet recruiting
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Seattle Children's Hospital

Seattle, United States, 98105

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Not yet recruiting
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Children's Mercy Hospital & Clinics

Kansas City, United States, 64108-9898

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Not yet recruiting
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Oregon Health and Science Univ | Doernbecher Childrens Hosp

Portland, United States, 97239

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Not yet recruiting
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Stanford Medicine

Palo Alto, United States, 94304

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Not yet recruiting
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Cleveland Clinic | Pediatric Nephrology

Cleveland, United States, 14013

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Not yet recruiting
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University of Iowa

Iowa City, United States, 52242

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Not yet recruiting
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Emory University Hospital/Children's Healthcare of Atlanta (CHOA)

Atlanta, United States, 30329

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Not yet recruiting
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Primary Children’s Hospital

Salt Lake City, United States, 84112

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Not yet recruiting
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University of California San Diego (UCSD)

La Jolla, United States, 92093

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Not yet recruiting
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South Broward Hosp. District dba Memorial Healthcare System

Hollywood, United States, 33021

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Not yet recruiting
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Children's Research Institute

Washington, United States, 20010

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Not yet recruiting
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Phoenix Children's Hospital | Main - Transplant Department

Phoenix, United States, 85016

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Not yet recruiting
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Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob

Baltimore, United States, 21287

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Not yet recruiting
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Children's Hospital of Philadelphia

Philadelphia, United States, 19104

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Not yet recruiting
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Hôpital des Enfants

TOULOUSE Cedex 9, France, 31059

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Recruiting
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Hôpital Pellegrin - Bordeaux

BORDEAUX, France, 33000

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Not yet recruiting
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CHU de Lyon - Hopital Femme Mère Enfant

BRON, France, 69677

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Recruiting
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Hôpital Arnaud de Villeneuve - Montpellier

MONTPELLIER, France, 34059

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Not yet recruiting
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CHU STRASBOURG - Hôpital de Hautepierre

STRASBOURG, France, 67098

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Not yet recruiting
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HOPITAL ROBERT DEBRE

PARIS, France, 75019

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Recruiting
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Instytut "Pomnik – Centrum Zdrowia Dziecka"

Warszawa, Poland, 04-730

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Recruiting
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Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

Bialystok, Poland, 15-274

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Not yet recruiting
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Instytut Centrum Zdrowia Matki Polki

Lodz, Poland, 93-338

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Recruiting
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Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-214

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Not yet recruiting
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

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Recruiting
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IRCCS Istituto Giannina Gaslini

Genova, Italy, 16147

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Recruiting
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A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Italy, 40138

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Recruiting
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IRCCS Ospedale Pediatrico Bambino Gesù

Roma, Italy, 00165

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Recruiting
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Virgen del Rocio University Hospital | Pediatric Nephrology Unit

Sevilla, Spain, 41013

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Recruiting
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Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

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Recruiting
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Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08023

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Recruiting
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Hospital de Sant Joan de Déu

Esplugues de LLobregat, Spain, 8950

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Recruiting
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Hospital Regional de Málaga

Málaga, Spain, 29010

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Not yet recruiting
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CHU Sainte-Justine

Montreal, Canada, H3T 1C5

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Not yet recruiting
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The Hospital for Sick Children (SickKids)

Toronto, Canada, M5G 1X8

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Not yet recruiting
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Alberta Children's Hospital, University of Calgary

Calgary, Canada, T3B 6A8

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Not yet recruiting
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UZ Gasthuisberg - Pediatric Nephrology

Leuven, Belgium, 3000

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Recruiting
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UZ Gent

GENT, Belgium, 9000

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Recruiting
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HUDERF / UKZKF

BRUXELLES - BRUSSEL, Belgium, 1020

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Not yet recruiting
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CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

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Not yet recruiting
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CHC Montlégia - Pediatrics

Liège, Belgium, 4000

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Not yet recruiting
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Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

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Not yet recruiting
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University Medical Center Utrecht

UTRECHT, Netherlands, 3584 CX

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Not yet recruiting
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Karolinska University Hospital

Stockholm, Sweden, 141 86

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Not yet recruiting
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Uppsala University Hospital

Uppsala, Sweden, 751 85

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Not yet recruiting
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Skåne University Hospital

Lund, Sweden, 221 85

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Not yet recruiting
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Aarhus Universitetshospital, Skejby

Århus N, Denmark, 8200

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Not yet recruiting
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Odense, HC Andersen

Odense C, Denmark, 5000

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Recruiting
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Rigshospitalet, Dept Pediatrics & Adelescent Med.

Copenhagen, Denmark, 2100

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Not yet recruiting
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Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 12808

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Recruiting
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Fakultni nemocnice v Motole

Praha 5, Czech Republic, 150 06

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Not yet recruiting
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Clalit Health Services Schneider Children's Medical Center

Petach Tikva, Israel, 4920235

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Not yet recruiting
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Dana-Dwek Children’s Hospital

Tel Aviv, Israel, 6423906

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Not yet recruiting
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Wilf Children's Hospital Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

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Not yet recruiting
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Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

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Recruiting
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Soroka University Medical Center

Beer Sheva, Israel, 8410101

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Not yet recruiting
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Monash Children's Hospital

Clayton, Australia, 3168

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Not yet recruiting
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Queensland Children’s Hospital

South Brisbane, Australia, 4101

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Recruiting
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Royal Children's Hospital Melbourne

Parkville, Australia, 3052

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Not yet recruiting
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Centro Hospitalar Universitario do Porto

Porto, Portugal, 4050-651

Status
Not yet recruiting
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Centro de Rehabilitacion Cardiovascular | San Luis, Argentina

San Luis, Argentina, D5700CGR

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Not yet recruiting
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Hospital de Niños "Ricardo Gutiérrez"

Buenos Aires, Argentina, C1425EFD

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Not yet recruiting
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Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina

Santa Fe, Argentina, S3000

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Not yet recruiting
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Hospital Italiano de Buenos Aires

Buenos Aires, Argentina, C1199ABB

Status
Not yet recruiting
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Hospital General de Niños Pedro de Elizalde

Ciudad de Buenos Aires, Argentina, C1270AAN

Status
Not yet recruiting
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Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Not yet recruiting
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Medizinische Universität Graz

Graz, Austria, 8036

Status
Not yet recruiting
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Kepler Universitätsklinikum Campus IV

Linz, Austria, 4020

Status
Recruiting
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Uniklinikum Salzburg - Landeskrankenhaus

Salzburg, Austria, 5020

Status
Not yet recruiting
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SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, Hungary, 6720

Status
Not yet recruiting
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Semmelweis University

Budapest, Hungary, 1083

Status
Not yet recruiting
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Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Status
Recruiting
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Pecsi Tudomanyegyetem Klinikai Kozpont

Pecs, Hungary, 7623

Status
Not yet recruiting
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Gazi Universitesi Tip Fakultesi

Ankara, Turkey, 06560

Status
Not yet recruiting
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Hacettepe Universitesi Tip Fakultesi

Ankara, Turkey, 06100

Status
Not yet recruiting
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Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali

Istanbul, Turkey, 34098

Status
Recruiting
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Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital

Ankara, Turkey, 06800

Status
Not yet recruiting
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Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

Istanbul, Turkey, 34899

Status
Not yet recruiting
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Baskent Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey, 06490

Status
Recruiting
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Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics

Istanbul, Turkey, 34093

Status
Not yet recruiting
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Children's Hospital of Athens P&A Kyriakou

Athens, Greece

Status
Recruiting
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University General Hospital of Heraklion

Crete, Greece, 71500

Status
Not yet recruiting
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Ioannina University General Hospital

Ioannina, Greece, 45500

Status
Recruiting
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Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece

Status
Not yet recruiting
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AGIA SOFIA Children's Hospital

Athens, Greece, 11527

Status
Not yet recruiting
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Seoul National University Hospital

Seoul, South Korea, 3080

Status
Recruiting
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Kyungpook National University Hospital

Daegu, South Korea, 41944

Status
Recruiting
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Pusan National University Yangsan Hospital

Yangsan-si, South Korea, 50612

Status
Recruiting
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Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

Status
Recruiting
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Vilnius University Hospital Santaros Klinikos Children‘s Hospital Paediatrics Centre

Vilnius, Lithuania, LT-08406

Status
Recruiting
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Hospital of LT University of Health Sciences Kaunas Clinics

Kaunas, Lithuania, LT-50161

Status
Not yet recruiting
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Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland, 1011

Status
Recruiting
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Universitäts-Kinderspital UKBB

Basel, Switzerland, 4056

Status
Not yet recruiting
Locations

HUS Uusi lastensairaala

Helsinki, Finland, 00290

Status
Recruiting
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Pediatric Early Phase Trial Unit, Tampere University Hospita

Tampere, Finland, 33521

Status
Recruiting
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Turun yliopistollinen keskussairaala

Turku, Finland, 20520

Status
Not yet recruiting

Trial Design