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

Andreas L. Serra

Status: Unknown

Conditions: Autosomal Dominant Polycystic Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02187432

Eurocyst

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

1,100 participants in 1 patient group

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).