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

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187432
• Other study ID #: Eurocyst
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: May 26, 2015
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: University of Zurich
• Contact: Andreas L Serra, MD
• Email: a.serra[@]gmx.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussel
Czech Republic	Charles University Prague	Prague
France	Centre hospitalier universitaire de Brest	Brest
France	Hôpital de Rangueil	Toulouse
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	University Hospital Erlangen	Erlangen
Germany	University Hospital Freiburg	Freiburg
Italy	Istituto di Ricerche Farmacologiche "Mario Negri"	Bergamo
Netherlands	University Medical Center Groningen	Groningen
Spain	Fundació Puigvert	Barcelona
Switzerland	University Hospital Zurich	Zurich
Turkey	Istanbul School of Medicine	Istanbul
United Kingdom	University of Cambridge, Cambridge Cancer Center	Cambridge
United Kingdom	University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Andreas L. Serra

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease progression	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	No
Secondary	QOL (Quality of Life)	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	No