Autosomal Dominant Polycystic Kidney DiseaseNCT02187432
The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Andreas L. Serra at 14 sites in 10 countries.
Trial summary
EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 1,100 participants
- Where
- 14 sitesin 10 countries
- Study dates
- Aug 2013to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 1,100 participants aged 18 and above with a diagnosis of ADPKD, diagnosed via imaging and family history. The assessment of participants is based on defined inclusion and exclusion criteria.
Who may be able to join
- Participants ≥ 18 years;
- Clinical diagnosis of ADPKD based on kidney imaging and family history;
- Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI)- formula);
- Provided written informed consent.
Who cannot join
- Receiving chronic renal replacement therapy before enrollment (dialysis, allograft) or anticipated in the following 12 months after enrollment;
- Participation in a clinical trial aiming to modify disease outcome one year or less before enrollment in the EuroCYST study;
- New York Heart Association (NYHA) stadium IV.
Trial locations and contacts
14 sites in 10 countries.
Andreas L Serra, MD contact
Andreas Serra, MD, MPH contact
14 sites in 10 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Charité Universitätsmedizin Berlin
Berlin, 10117
Klemens Budde, Prof, klemens.budde@charite.de
Klemens Budde, MD
- Not yet recruiting
University Hospital Erlangen
Erlangen, 91054
Kai-Uwe Eckardt, Prof, Kai-Uwe.Eckardt@uk-erlangen.de
Kai-Uwe Eckardt, Prof
- Not yet recruiting
University Hospital Freiburg
Freiburg im Breisgau, 79095
Anna Koettgen, MD, anna.koettgen@uniklinik-freiburg.de
Anna Koettgen, MD
France2 sites, 2 recruiting
- Not yet recruiting
Centre hospitalier universitaire de Brest
Brest, 29609
Yannick Le Meur, Prof, yannick.lemeur@chu-brest.fr
Yannick Le Meur, Prof
- Not yet recruiting
Hôpital de Rangueil
Toulouse, 31059
Dominique Chaveau, Prof, chauveau.d@chu-toulouse.fr
Dominique Chaveau, Prof
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
University of Cambridge, Cambridge Cancer Center
Cambridge, CB2 0XY
Richard Sandford, Prof, rns13@medschl.cam.ac.uk
Richard Sandford, Prof
- Not yet recruiting
University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity
Sheffield, S10 2RX
Albert CM Ong, Prof, a.ong@sheffield.ac.uk
Albert CM Ong, Prof
Belgium1 site, 1 recruiting
- Not yet recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Yves Pirson, Prof, yves.pirson@uclouvain.be
Yves Pirson, Prof
Czechia1 site, 1 recruiting
- Not yet recruiting
Charles University Prague
Prague, 128 08
Vladimir Tesar, Prof, vladimir.tesar@lf1.cuni.cz
Vladimir Tesar, Prof
Italy1 site, 1 recruiting
- Not yet recruiting
Istituto di Ricerche Farmacologiche "Mario Negri"
Bergamo, 24126
Giuseppe Remuzzi, Prof, giuseppe.remuzzi@marionegri.it
Giuseppe Remuzzi, Prof
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713
Ron Gansevoort, MD, R.T.Gansevoort@int.umcg.nl
Ron Gansevoort, MD
Spain1 site, 1 recruiting
- Not yet recruiting
Fundació Puigvert
Barcelona, 08025
Roser Torra, MD, rtorra@fundacio-puigvert.es
Roser Torra, MD
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Hospital Zurich
Zurich, 8091
Andreas L Serra, MD, +41 44 635 51 07, a.serra@gmx.ch
Andreas L Serra, MD
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Istanbul School of Medicine
Istanbul, 34390
Tefvik Ecder, Prof, ecder@istanbul.edu.tr
Tefvik Ecder, Prof
About this study
Official title: The Eurocyst Initiative: Building a Reference Center Network Across EUROpe to Establish a Large-scale Longitudinal Observational Cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) Patients
EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.
Read the detailed description
The EuroCYST Initiative aims to build a network of ADPKD reference centers across Europe and to establish a large-scale observational cohort of ADPKD patients for the purpose of studying the pathogenesis, rate of disease progression, progression rate modifiers, disease stage specific morbidity, mortality, health economic issues and the predictive value of biomarkers in ADPKD. Overall 1,100 patients will be enrolled in 14 study sites across Europe and will be followed up for at least three years. The ADPKD reference center network across Europe and the observational cohort study will enable European ADPKD researchers to gain insight into the natural history, heterogeneity and associated complications of the disease as well as how it affects the lives of patients across Europe.
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
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 |
|---|---|---|
| ADPKD | EuroCYST is and observational trail aiming to investigate disease progression across the different stages of disease and stage specific morbidity and mortality factors in a longitudinal observational multi center study and to evaluate the levels of and associations between the impacts of patients reported disease outcome (quality of life (QoL), pain, self-estimated health status, health burden). |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease progression
Investigate disease progression and association of disease biomarkers with the onset and severity of ADPKD-related outcomes.
Measured: participants will be followed annually for at least 3 years
Secondary outcomes (1)
QOL (Quality of Life)
Evaluate and establish the level of disease impact on self-estimated health status, pain, QoL, socioeconomic status (SES), ADPKD-related health burden, health care resource use.
Measured: participants will be followed annually for at least 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic 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
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andreas L. Serra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andreas L. Serra, University of Zurich
- Investigators
- Andreas L Serra, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187432
- Sponsor's protocol ID
- Eurocyst
- Status last verified
- May 2015
- First submitted
- 24 Feb 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Eurocyst Initiative: Building a Reference Center Network Across EUROpe to Establish a Large-scale Longitudinal Observational Cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) Patients
- ClinicalTrials.gov ID
- NCT02187432
- Acronym / sponsor ID
- Eurocyst
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Andreas L. SerraUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Jul 2014 (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.
EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.
Detailed description
The EuroCYST Initiative aims to build a network of ADPKD reference centers across Europe and to establish a large-scale observational cohort of ADPKD patients for the purpose of studying the pathogenesis, rate of disease progression, progression rate modifiers, disease stage specific morbidity, mortality, health economic issues and the predictive value of biomarkers in ADPKD. Overall 1,100 patients will be enrolled in 14 study sites across Europe and will be followed up for at least three years. The ADPKD reference center network across Europe and the observational cohort study will enable European ADPKD researchers to gain insight into the natural history, heterogeneity and associated complications of the disease as well as how it affects the lives of patients across Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADPKD | – | –EuroCYST is and observational trail aiming to investigate disease progression across the different stages of disease and stage specific morbidity and mortality factors in a longitudinal observational multi center study and to evaluate the levels of and associations between the impacts of patients reported disease outcome (quality of life (QoL), pain, self-estimated health status, health burden). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 1,100 participants aged 18 and above with a diagnosis of ADPKD, diagnosed via imaging and family history. The assessment of participants is based on defined inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Participants ≥ 18 years;
- Clinical diagnosis of ADPKD based on kidney imaging and family history;
- Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI)- formula);
- Provided written informed consent.
Key exclusion criteria (3 listed)
- Receiving chronic renal replacement therapy before enrollment (dialysis, allograft) or anticipated in the following 12 months after enrollment;
- Participation in a clinical trial aiming to modify disease outcome one year or less before enrollment in the EuroCYST study;
- New York Heart Association (NYHA) stadium IV.
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
disease progression
Time frame: participants will be followed annually for at least 3 years
Investigate disease progression and association of disease biomarkers with the onset and severity of ADPKD-related outcomes.
1 secondary outcome
QOL (Quality of Life)
Time frame: participants will be followed annually for at least 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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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.
Andreas L Serra, MD contact
Andreas Serra, MD, MPH contact
Andreas L Serra, MD principal investigator
University of Zurich
14 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Andreas L. Serra at 14 sites in 10 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 4 inclusion and 3 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, France, United Kingdom, Belgium, Czechia and 5 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 Andreas L Serra, MD (a.serra@gmx.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease progression (time frame: participants will be followed annually for at least 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 27 May 2015.