Clinical trial NCT02187432: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autosomal Dominant Polycystic Kidney Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: disease progression
timeFrame: participants will be followed annually for at least 3 years
Secondary outcomes:
measure: QOL (Quality of Life)
timeFrame: participants will be followed annually for at least 3 years
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Prague
country: Czech Republic
facility: Charles University Prague
city: Brest
country: France
facility: Centre hospitalier universitaire de Brest
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Bergamo
country: Italy
facility: Istituto di Ricerche Farmacologiche "Mario Negri"
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Istanbul
country: Turkey
facility: Istanbul School of Medicine
city: Cambridge
country: United Kingdom
facility: University of Cambridge, Cambridge Cancer Center
city: Sheffield
country: United Kingdom
facility: University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity
Study officials:
affiliation: University of Zurich
name: Andreas L Serra, MD
role: PRINCIPAL_INVESTIGATOR
References: