The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe

May 26, 2015 updated by: Andreas L. Serra

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1200
        • Not yet recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
        • Principal Investigator:
          • Yves Pirson, Prof
  • Czech Republic
      • Prague, Czech Republic, 128 08
        • Not yet recruiting
        • Charles University Prague
        • Contact:
        • Principal Investigator:
          • Vladimir Tesar, Prof
  • France
      • Brest, France, 29609
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Brest
        • Contact:
        • Principal Investigator:
          • Yannick Le Meur, Prof
      • Toulouse, France, 31059
        • Not yet recruiting
        • Hopital de Rangueil
        • Contact:
        • Principal Investigator:
          • Dominique Chaveau, Prof
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité Universitätsmedizin Berlin
        • Principal Investigator:
          • Klemens Budde, MD
        • Contact:
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • University Hospital Erlangen
        • Contact:
        • Principal Investigator:
          • Kai-Uwe Eckardt, Prof
      • Freiburg, Germany, 79095
  • Italy
      • Bergamo, Italy, 24126
        • Not yet recruiting
        • Istituto di Ricerche Farmacologiche "Mario Negri"
        • Contact:
        • Principal Investigator:
          • Giuseppe Remuzzi, Prof
  • Netherlands
      • Groningen, Netherlands, 9713
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • Principal Investigator:
          • Ron Gansevoort, MD
  • Spain
      • Barcelona, Spain, 08025
        • Not yet recruiting
        • Fundacio Puigvert
        • Principal Investigator:
          • Roser Torra, MD
        • Contact:
  • Switzerland
      • Zurich, Switzerland, 8091
        • Not yet recruiting
        • University Hospital Zurich
        • Contact:
          • Andreas L Serra, MD
          • Phone Number: +41 44 635 51 07
          • Email: a.serra@gmx.ch
        • Principal Investigator:
          • Andreas L Serra, MD
  • Turkey
      • Istanbul, Turkey, 34390
        • Not yet recruiting
        • Istanbul School of Medicine
        • Contact:
        • Principal Investigator:
          • Tefvik Ecder, Prof
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0XY
        • Not yet recruiting
        • University of Cambridge, Cambridge Cancer Center
        • Contact:
        • Principal Investigator:
          • Richard Sandford, Prof
      • Sheffield, United Kingdom, S10 2RX
        • Not yet recruiting
        • University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity
        • Contact:
        • Principal Investigator:
          • Albert CM Ong, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed annually for at least 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed annually for at least 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andreas L. Serra

Investigators

  • Principal Investigator: Andreas L Serra, MD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eurocyst

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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