Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006478

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006478
  •   2014/11/05
  •   2014/02/24
  •   yes
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Secondary IDs

  •   NCT02187432  (ClinicalTrials.gov)
  •   Eurocyst  (University of Zurich)
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Health Condition or Problem studied

  •   Autosomal Dominant Polycystic Kidney Disease
  •   Q61.2 -  Polycystic kidney, autosomal dominant
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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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.

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Secondary Outcome

- QOL (Quality of Life); time frame: participants will be followed annually for at least 3 years; 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.

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Countries of Recruitment

  •   Belgium
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Spain
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/08/31
  •   1100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- 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.

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Exclusion Criteria

- 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.

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Addresses

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    • University of Zurich
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    • University of Zurich
    • Andreas L Serra, MD 
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    • Andreas L Serra, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/12/02


* This entry means the parameter is not applicable or has not been set.