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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02187432

Enrollment

1100

Registered

2014-07-11

Start date

2013-08-31

Completion date

2016-12-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
disease progression	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.

Secondary

Measure	Time frame	Description
QOL (Quality of Life)	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.

Countries

Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Contacts

Primary ContactAndreas L Serra, MD

a.serra@gmx.ch

Backup ContactAndreas Serra, MD, MPH