Chronic Kidney Disease4CNCT01046448
The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study
An observational study of Chronic Kidney Disease and Pediatric, run by Heidelberg University at 50 sites in 15 countries.
Trial summary
Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Chronic Kidney Disease, Pediatric, Cardiovascular Disease
- How many people
- 650 participants
- Where
- 50 sitesin 15 countries
- Study dates
- Jul 2009to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 650 children with CKD stage IIIb to V (GFR 10-45 ml/min/1.73m²). Children who reach end-stage renal disease will be continuously followed while on renal replacement therapy.
Who may be able to join
- Age 6 to 17 years
- GFR 10 to 45 ml/min/1.73m² (CKD stage IIIb to V);
Who cannot join
- Active systemic vasculitis
- Diabetes mellitus
- Renal vascular anomalies
- Anomalies of the limbs preventing standardized diagnostic procedures
Trial locations and contacts
50 sites in 15 countries.
50 sites in 15 countries
Turkey (Türkiye)15 sites, 15 recruiting
- Recruiting
Cukurova Universitesi
Adana, 01330
Bayazit Aysun, MD, +90 322 3386832, ayskar@cu.edu.tr
Anarat Ali, MD, +90 322 3386832, anarat@cu.edu.tr
- Not yet recruiting
Ankara University of Medicine
Ankara, 06100
Fatos Yalcinkaya, MD, +90 312 5956708, yalcinkaya@tr.net
- Not yet recruiting
Hacettepe Medical Faculty
Ankara, 06100
Ali Duzova, MD, +90 3123051863
Aysin Bakkaloglu, MD, + 90 3123051863, aysin@hacettepe.edu.tr
- Not yet recruiting
Gazi University Hospital
Ankara, 06500
Oguz Soylemezoglu, MD, + 90 312 202 5202, oguzs@gazi.edu.tr
- Not yet recruiting
Baskent University, Faculty of Medicine
Ankara
Esra Baskin, MD, esrabaskin@yahoo.com
- Not yet recruiting
Diskapi Childrens Hospital
Ankara
Nilgun Cakar, MD, nilguncakar@hotmail.com
- Not yet recruiting
Sami Ulus Childrens Hospital
Ankara
Gulay Demircin, MD, gulaydemircin@hotmail.com
- Recruiting
Cerrahpasa Tip Fakultesi
Istanbul, 34303
Salim Caliskan, MD, +90 532 212 1302, salimc@istanbul.edu.tr
- Not yet recruiting
Istanbul Medical Faculty
Istanbul, 34360
Sevinc Emre, MD, +90 532 616 2569, semre@istanbul.edu.tr
- Not yet recruiting
Bakirkoy Children's Hospital
Istanbul
Nur Canpolat, MD, +90 5324423590, ncanpolat2000@hotmail.com
- Not yet recruiting
Goztepe Educational and Research Hospital
Istanbul
Nurdan Yildiz, MD, +90 506 2392539, nurdanyl@yahoo.com.tr
- Not yet recruiting
Haseki Educational and Research Hospital
Istanbul
Mahmut Civilibal, MD, +90 532 242 8989, drcivilibal@hotmail.com
Mahmut Civilibal, MD
- Not yet recruiting
Marmara University Medical Faculty
Istanbul
Harika Alpay, MD, +90 532 645 1515, dhtalpay@superonline.com
- Not yet recruiting
Sisli Educational and Research Hospital
Istanbul
Gul Ozcelik, MD, +90 542 233 4626, ozcelik62@gmail.com
- Not yet recruiting
Ege University
Izmir, 35100
Betül Sözeri, MD, +90 232390 1263, betulsozeri@yahoo.com
Sevgi Mir, MD, +90 232390 1001, sevgi.mir@ege.edu.tr
Germany12 sites, 12 recruiting
- Not yet recruiting
Charité Children's Hospital
Berlin, 13353
René Zeller, MD, +30 450 516 031, rene.zeller@charite.de
Uwe Querfeld, MD, +30 450 516 031, uwe.querfeld@charite.de
- Not yet recruiting
University Children's Hospital
Cologne, 50937
Bernd Hoppe, MD, bernd.hoppe@uk-koeln.de
- Not yet recruiting
University Children's Hospital
Erlangen, 91054
Eva-Maria Rüth, MD, +49 91318536097, eva-maria.rueth@uk-erlangen.de
- Not yet recruiting
University Children's Hospital
Essen, 45122
Rainer Büscher, MD, +49 201 723 3780, rainer.buescher@uk-essen.de
- Not yet recruiting
Center for Pediatrics and Adolescent Medicine
Freiburg im Breisgau, 79106
Martin Pohl, MD, +761 270 4531, martin.pohl@uniklinik-freiburg.de
- Not yet recruiting
UKE University Children's Hospital
Hamburg, 20246
Dirk E. Mueller-Wiefel, MD, +49 40 74105 2702, muellerw@uke.uni-hamburg.de
- Recruiting
Hannover Medical School
Hanover, 30625
Daniela Kracht, MD, +49 511 532 3213, kracht.daniela@mh-hannover.de
Anette Melk, MD, +49 511 532 5597, melk.anette@mh-hannover.de
- Recruiting
Center for Pediatrics and Adolescent Medicine
Heidelberg, 69120
Anke Doyon, MD, +49 6221 56 ext. 37296, anke.doyon@med.uni-heidelberg.de
Elke Wühl, MD, +49 6221 56 ext. 39318, elke.wuehl@med.uni-heidelberg.de
- Not yet recruiting
City Hospital St. Georg
Leipzig, 04129
Simone Wygoda, MD, +49 3419093640, simone.wygoda@kfh-dialyse.de
- Not yet recruiting
KfH Kidney Center for Children
Marburg, 35043
Nikola Jeck, +49 6421 586 2650, jeckn@staff.uni-marburg.de
- Not yet recruiting
University Children's Hospital
Münster, 48149
Martin Konrad, MD, konradma@uni-muenster.de
- Not yet recruiting
Children's Hospital
Rostock, 18057
Marianne Wigger, MD, +49 381 494 7158, marianne.wigger@med.uni-rostock.de
Italy6 sites, 6 recruiting
- Not yet recruiting
S. Orsola-Malphighi Hospital
Bologna, 40123
Giovanni Montini, MD, +39 6364617, giovanni.montini@aosp.bo.it
- Not yet recruiting
Istituto Giannina Gaslini
Genova, 16147
Alberto Canepa, MD, +39 010 5636275, albertocanepa@ospedale-gaslini.ge.it
- Not yet recruiting
Fondazione OSP Maggiore Policlinico
Milan, 20122
Sara Testa, MD, +39 0259032300, saratesta@tiscali.it
- Not yet recruiting
University of Padova
Padova, 35128
Luisa Murer, MD, +49 049 8213596, murer@pediatria.unipd.it
- Not yet recruiting
Bambino Gesu
Rome, 00163
Chiara Matteucci, MD, matteucc@opbg.net
- Not yet recruiting
Regina Margherita Children's Hospital
Torino, 10126
Licia Peruzzi, MD, +39 0113131761, liciaperuzzi@hotmail.com
Poland4 sites, 4 recruiting
- Not yet recruiting
Medical University Gdansk
Gdansk, 80211
Aleksandra Zurowska, MD, +48 601919335, azur@amq.qda.pl
- Not yet recruiting
University Children's Hospital
Krakow, 30-663
Dorota Drozdz, MD, +48 604 787415, dadrozdz@cm-uj.krakow.pl
- Not yet recruiting
Clinic of Pediatrics
Szczecin, 71-344
- Not yet recruiting
Children's Memorial Health Institute
Warsaw, 04-730
Mieczyslaw Litwin, MD, +48 228151603, m.liwin@czd.pl
Anna Niemirska, MD, +48 228151603, aniemirska@oz.pl
France2 sites, 2 recruiting
- Not yet recruiting
Service de Pédiatrie & Inserm U820
Lyon, 69677
Pierre Cochat, MD, +33 4 72119338, pierre.cochat@chu-lyon.fr
- Not yet recruiting
Hôpital de Hautepierre
Strasbourg, 67098
Michel Fischbach, MD, +33 388127743, michel.fischbach@chru-strasbourg.fr
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Inselspital
Bern, 3010
Giacomo Simonetti, MD, giacomo.simonetti@insel.ch
- Not yet recruiting
University Children's Hospital
Zurich, 8032
Guido Laube, MD, +41 442667390, guido.laube@kispi.uzh.ch
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Vienna
Vienna, 1010
Klaus Arbeiter, MD, +43 1 40400 3257, klaus.arbeiter@meduniwien.ac.at
Belgium1 site, 1 recruiting
- Not yet recruiting
UZ Gent
Ghent, 9000
Johan Vande Walle, MD, +32 9 332 2483, johan.vandewalle@ugent.be
Czechia1 site, 1 recruiting
- Not yet recruiting
University Hospital Motol
Prague, 15006
Jiri Dusek, MD, +420 224 432 044, j.dusek@lfmotol.cuni.cz
Hungary1 site, 1 recruiting
- Not yet recruiting
Semmelweis University
Budapest, 1083
Betti Schaefer, MD, +36 13343186, bettus13@gmail.com
Lithuania1 site, 1 recruiting
- Not yet recruiting
Vilnius University Children's Hospital
Vilnius, 08406
Augustina Jankauskiene, MD, +370 52720427, augustinajankauskiene@yahoo.com
Portugal1 site, 1 recruiting
- Not yet recruiting
Hospital Sao Joao
Porto, 4200
Ana Teixeira, MD, anafteixeira@gmail.com
Serbia1 site, 1 recruiting
- Not yet recruiting
University Children's Hospital
Belgrade, 11000
Amira Peco-Antic, MD, +381 64 328 9191, amira@udk.bg.ac.yu
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm, 14186
Rafael Krmar, MD, +46 858581480, rafael.krmar@klinvet.ki.se
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Great Ormond Street Hospital
London, WC1N3JH
Rukshana Shroff, MD, +44 207 4059200, shrofr@gosh.nhs.uk
About this study
Official title: The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities.
The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still elusive. In this multicenter, prospective, observational study the prevalence, degree and progression of CV comorbidity in children will be characterized and related to CKD progression. The morphology and function of the heart and vessels will be monitored by sensitive, non-invasive methods and will be compared with aged matched healthy controls. Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors will be monitored prospectively and will be related to CV status. Genotyping might identify predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.
Read the detailed description
Adult patients with CKD are at markedly increased risk of dying from cardiovascular events. The risk is most dramatically increased in young patients with end-stage renal disease, who are almost as likely to die from cardiovascular causes as elderly individuals in the general population.
Early morphological and functional vascular abnormalities can be detected even in adolescents with CKD, but information about the prevalence, severity and natural course of vascular lesions in different stages of renal failure is lacking and the factors predisposing to an early onset and rapid progression of cardiovascular morbidity are still elusive.
The pediatric population appears uniquely suited to study the effects of CKD on the cardiovascular system due to the virtual absence of vascular morbidity related to ageing, diabetes and smoking.
In order to improve our understanding of the causes and consequences of cardiovascular comorbidity in children with progressive CKD, a consortium of pediatric nephrologists in Europe has joined to perform a long-term prospective observational study following the cardiovascular health of children as they advance through successive stages of CKD.
The 4C Study will follow up at least 625 patients aged 6 to 17 years with a glomerular filtration rate of 10 to 45 ml/min/1.73 m² in more than 40 pediatric nephrology units in 14 European countries.
The morphology and function of the heart and the large arteries is regularly assessed by sensitive, non-invasive methods and the findings compared to a large group of healthy children.
Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors are monitored prospectively and will be related to the cardiovascular status of the patients.
A whole genome association study will be performed to identify genetic variants associated with the progression of cardio-vascular alterations and renal failure.
- Conditions
- Chronic Kidney Disease, Pediatric, Cardiovascular Disease
- Keywords
- Children, chronic renal failure, chronic kidney disease, cardiovascular disease, cardiovascular morbidity, left ventricular hypertrophy, carotid intima media thickness, arterial stiffness, pulse wave velocity, augmentation index, left ventricular cardiac function, progression, genetic risk factors, vasculopathy, cardiopathy, whole genome analysis, haplotype analysis, SNP-screening
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases, Kidney Failure, Chronic, Hypertrophy, Left Ventricular, Disease Progression, Vascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 4C | Children with chronic kidney disease stage IIIb to V (GFR 10 to 45 ml/min/1.73m²) at screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and morphological evidence of cardiovascular disease progression (arterial stiffness, myocardial dysfunction, cIMT, LVMI) and association with clinical, anamnestic, anthropometric, biochemical, drug-related and genetic risk factors
Measured: 3 years
Secondary outcomes (1)
Genetic risk factors for early manifesting progressive vascular lesions and progressive kidney disease by the genome-wide SNP-screening and haplotype analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- KfH Foundation for Preventive Medicine, German Federal Ministry of Education and Research
- Investigators
- Franz Schaefer, MD, Principal investigator, Center for Pediatric and Adolescent Medicine, University of Heidelberg, GermanyUwe Querfeld, MD, Principal investigator, Klinik für Pädiatrie m.S. Nephrologie, Charite, 13353 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046448
- Sponsor's protocol ID
- S-32/2009
- Acronym
- 4C
- Status last verified
- Jan 2010
- First submitted
- 7 Aug 2009
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular Morbidity in Children With Chronic Renal Failure Study
- ClinicalTrials.gov ID
- NCT01046448
- Acronym / sponsor ID
- 4C / S-32/2009
- Conditions
- Chronic Kidney Disease, Pediatric, Cardiovascular Disease
- Keywords
- Children, chronic renal failure, chronic kidney disease, cardiovascular disease, cardiovascular morbidity, left ventricular hypertrophy, carotid intima media thickness, arterial stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- KfH Foundation for Preventive Medicine, German Federal Ministry of Education and Research
- Study start
- Jul 2009
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities.
The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still elusive. In this multicenter, prospective, observational study the prevalence, degree and progression of CV comorbidity in children will be characterized and related to CKD progression. The morphology and function of the heart and vessels will be monitored by sensitive, non-invasive methods and will be compared with aged matched healthy controls. Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors will be monitored prospectively and will be related to CV status. Genotyping might identify predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.
Detailed description
Adult patients with CKD are at markedly increased risk of dying from cardiovascular events. The risk is most dramatically increased in young patients with end-stage renal disease, who are almost as likely to die from cardiovascular causes as elderly individuals in the general population.
Early morphological and functional vascular abnormalities can be detected even in adolescents with CKD, but information about the prevalence, severity and natural course of vascular lesions in different stages of renal failure is lacking and the factors predisposing to an early onset and rapid progression of cardiovascular morbidity are still elusive.
The pediatric population appears uniquely suited to study the effects of CKD on the cardiovascular system due to the virtual absence of vascular morbidity related to ageing, diabetes and smoking.
In order to improve our understanding of the causes and consequences of cardiovascular comorbidity in children with progressive CKD, a consortium of pediatric nephrologists in Europe has joined to perform a long-term prospective observational study following the cardiovascular health of children as they advance through successive stages of CKD.
The 4C Study will follow up at least 625 patients aged 6 to 17 years with a glomerular filtration rate of 10 to 45 ml/min/1.73 m² in more than 40 pediatric nephrology units in 14 European countries.
The morphology and function of the heart and the large arteries is regularly assessed by sensitive, non-invasive methods and the findings compared to a large group of healthy children.
Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors are monitored prospectively and will be related to the cardiovascular status of the patients.
A whole genome association study will be performed to identify genetic variants associated with the progression of cardio-vascular alterations and renal failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4C | – | –Children with chronic kidney disease stage IIIb to V (GFR 10 to 45 ml/min/1.73m²) at screening. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 650 children with CKD stage IIIb to V (GFR 10-45 ml/min/1.73m²). Children who reach end-stage renal disease will be continuously followed while on renal replacement therapy.
Key inclusion criteria (2 listed)
- Age 6 to 17 years
- GFR 10 to 45 ml/min/1.73m² (CKD stage IIIb to V);
Key exclusion criteria (4 listed)
- Active systemic vasculitis
- Diabetes mellitus
- Renal vascular anomalies
- Anomalies of the limbs preventing standardized diagnostic procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional and morphological evidence of cardiovascular disease progression (arterial stiffness, myocardial dysfunction, cIMT, LVMI) and association with clinical, anamnestic, anthropometric, biochemical, drug-related and genetic risk factors
Time frame: 3 years
1 secondary outcome
Genetic risk factors for early manifesting progressive vascular lesions and progressive kidney disease by the genome-wide SNP-screening and haplotype analysis.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Click here for more information about this study: 4C-StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franz Schaefer, MD principal investigator
Center for Pediatric and Adolescent Medicine, University of Heidelberg, Germany
Uwe Querfeld, MD principal investigator
Klinik für Pädiatrie m.S. Nephrologie, Charite, 13353 Berlin, Germany
50 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Pediatric, run by Heidelberg University at 50 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Turkey (Türkiye), Germany, Italy, Poland, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franz S Schaefer, MD (+49 6221 56 ext. 2349, franz.schaefer@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and morphological evidence of cardiovascular disease progression (arterial stiffness, myocardial dysfunction, cIMT, LVMI) and association with clinical, anamnestic, anthropometric, biochemical, drug-related and genetic risk factors (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.