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:

NCT05196035

EudraCT Number:

2021-002071-19

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 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 D0
Exclusion Criteria
- Planned urological surgery expected to influence renal function 
- Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
- Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
- Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
- Renal allograft in place
- Bilateral renal artery stenosis 
- Acute kidney injury requiring dialysis within 6 months prior to screening 
- Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization 
- Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
- Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg)
- Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids, within <6 months prior to screening for any reason

Trial Summary

Enrollment Goal
219
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

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Recruiting
 
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Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

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Medizinische Hochschule Hannover (MHH)

Hannover, Germany, 30625

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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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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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Birmingham Children's Hospital

Birmingham, United Kingdom, B4 6NH

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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, G51 4TF

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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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Boston hildren's Hospital

Boston, United States, 02115

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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 cedex, France, 33076

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CHU de Lyon - Hopital Femme Mère Enfant

BRON, France, 69677

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Hôpital Arnaud de Villeneuve - Montpellier

MONTPELLIER, France, 34059

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Recruiting
 
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CHU STRASBOURG - Hôpital de Hautepierre

Strasbourg, France, 67200

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HOPITAL ROBERT DEBRE

Paris, France, 75019

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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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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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H Univ. Virgen Rocío | Unidad Nefrología Pediátrica

Sevilla, Spain, 41013

Status
Recruiting
 
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Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08023

Status
Recruiting
 
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Hospital de Sant Joan de Déu

Esplugues de LLobregat, Spain, 08950

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Recruiting
 
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Hospital Regional de Málaga

Málaga, Spain, 29010

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Recruiting
 
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H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)

Madrid, Spain, 28041

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Recruiting
 
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UZ Leuven Gasthuisberg

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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CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

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Universitair Medisch Centrum Groningen

GRONINGEN, Netherlands, 9713 GZ

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Karolinska University Hospital

Stockholm, Sweden, 141 86

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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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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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Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 12808

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Fakultni nemocnice v Motole

Praha 5, Czech Republic, 150 06

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Clalit Health Services Schneider Children's Medical Center

Petach Tikva, Israel, 4920235

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Dana-Dwek Children’s Hospital

Tel Aviv, Israel, 6423906

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Wilf Children's Hospital Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

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Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

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Soroka University Medical Center

Beer Sheva, Israel, 8410101

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Monash Children's Hospital

Clayton, Australia, 3168

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Queensland Children’s Hospital

South Brisbane, Australia, 4101

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Royal Children's Hospital Melbourne

Parkville, Australia, 3052

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Centro Hospitalar Universitario do Porto

Porto, Portugal, 4050-651

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CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

Lisboa, Portugal, 1649-035

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Centro Clinico Academico - Braga

Braga, Portugal, 4710-243

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AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie

Wien, Austria, 1090

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Recruiting
 
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Medizinische Univ Graz | Kinder & Jugendheilkunde

Graz, Austria, 8036

Status
Recruiting
 
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Kepler Universitätsklinikum Campus IV

Linz, Austria, 4020

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Recruiting
 
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Uniklinikum Salzburg - Landeskrankenhaus

Salzburg, Austria, 5020

Status
Recruiting
 
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SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, Hungary, 6720

Status
Recruiting
 
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Semmelweis University

Budapest, Hungary, 1083

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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
Recruiting
 
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Gazi Universitesi Tip Fakultesi

Ankara, Turkey, 06560

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Recruiting
 
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Hacettepe Universitesi Tip Fakultesi

Ankara, Turkey, 06100

Status
Recruiting
 
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Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali

Istanbul, Turkey, 34098

Status
Recruiting
 
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Ankara Sehir Hastanesi

Ankara, Turkey, 06800

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

Istanbul, Turkey, 34899

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Not yet recruiting
 
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Baskent Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey, 06490

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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Seoul National University Hospital

Seoul, South Korea, 03080

Status
Recruiting
 
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Kyungpook National University Hospital

Daegu, South Korea, 41944

Status
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Pusan National University Yangsan Hospital

Yangsan-si, South Korea, 50612

Status
Not yet recruiting
 
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Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

Status
Recruiting
 
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Children’s hospital Affiliate of Vilnius University Hospital

Vilnius, Lithuania, LT-08661

Status
Recruiting
 
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Hospital of LT University of Health Sciences Kaunas Clinics

Kaunas, Lithuania, LT-50161

Status
Recruiting
 
Locations

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland, 1011

Status
Recruiting
 
Locations

HUS Uusi lastensairaala

Helsinki, Finland, 00290

Status
Recruiting
 
Locations

Pediatric Early Phase Trial Unit, Tampere University Hospita

Tampere, Finland, 33521

Status
Not yet recruiting
 
Locations

Turun yliopistollinen keskussairaala

Turku, Finland, 20520

Status
Recruiting
 
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Cincinnati Children's Hospital and Medical Center

Cincinnati, United States, 45229

Status
Not yet recruiting
 
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Stanford Medicine

Palo Alto, United States, 94304

Status
Not yet recruiting
 
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CHU Sainte-Justine

Montreal, Canada, H3T 1C5

Status
Not yet recruiting
 
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The Hospital for Sick Children (SickKids)

Toronto, Canada, M5G 1X8

Status
Not yet recruiting
 
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Univ of Texas Health Science Center | Nephrology Res Dept

San Antonio, United States, 78207

Status
Not yet recruiting
 
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Seattle Children's Hospital

Seattle, United States, 98105

Status
Not yet recruiting
 
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Universitäts-Kinderspital UKBB

Basel, Switzerland, 4056

Status
Not yet recruiting
 
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Cleveland Clinic | Pediatric Nephrology

Cleveland, United States, 14013

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

Calgary, Canada, T3B 6A8

Status
Not yet recruiting
 
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Instytut Centrum Zdrowia Matki Polki

Lodz, Poland, 93-338

Status
Not yet recruiting
 
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Kindernierenzentrum Bonn

Köln, Germany, 50858

Status
Not yet recruiting
 
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Charité / Pädiatrie

Berlin, Germany, 13353

Status
Not yet recruiting
 

Trial Design