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

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Brief Title

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

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

Brief 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 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 Type

Observational


Primary Outcome

disease progression

Secondary Outcome

 QOL (Quality of Life)

Condition

Autosomal Dominant Polycystic Kidney Disease


Study Arms / Comparison Groups

 ADPKD
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1100

Start Date

August 2013

Completion Date

December 2016

Primary Completion Date

December 2015

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andreas L Serra, MD, , [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT02187432

Organization ID

Eurocyst


Responsible Party

Sponsor-Investigator

Study Sponsor

Andreas L. Serra


Study Sponsor

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


Verification Date

May 2015