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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05524467
Other study ID # CS-DFK-2021-0712
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 2, 2023
Est. completion date June 2024

Study information

Verified date December 2023
Source Vifor Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vifor International Inc. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.


Description:

This is a non-interventional, cross-sectional, multicentre, and multinational (European) study. The non-interventional study (NIS) design allows the observation of patients in large haemodialysis (HD) centres reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by the sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour. The CENSUS-EU represents a cross-sectional study design of a representative selection of patients undergoing HD at 113 large dialysis centres across 7 countries in Europe. Prot. v.2.0, 9 May 2023


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3100
Est. completion date June 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female adult patients with CKD (=18 years) receiving HD for at least 3 months prior to signing informed consent - Signed informed consent - Able and willing to fill in questionnaires Exclusion Criteria: - Patients performing HD at home or both home and centre

Study Design


Locations

Country Name City State
Germany 1113 Aschaffenburg
Germany 1011 Balingen
Germany 1007 Braunschweig
Germany 1012 Eisenach
Germany 1043 Flensburg
Germany 1048 Freiburg
Germany 1049 Freiburg
Germany 1001 Herne
Germany 1035 Kiel
Germany 1111 Leipzig
Germany 1047 Saalfeld/Saale
Germany 1053 Sömmerda
Germany 1044 Witten
Italy 4027 Acquaviva Delle Fonti
Italy 4010 Civitavecchia
Italy 4001 Firenze
Italy 4005 Lecce
Italy 4008 Macerata
Italy 4023 Mestre
Italy 4006 Milano
Italy 4018 Milano
Italy 4021 Milano
Italy 4011 Modena
Italy 4009 Monza
Italy 4017 Parma
Italy 4028 Pisa
Italy 4002 Pistoia
Italy 4026 Reggio Calabria
Italy 4024 Rome
Italy 4022 Treviso
Italy 4012 Verona
Portugal 5001 Faro
Portugal 5011 Gondomar
Portugal 5006 Leiria
Portugal 5008 Porto
Portugal 5002 Sacavém
Spain 3006 Almería
Spain 3005 Barcelona
Spain 3012 Barcelona
Spain 3026 Barcelona
Spain 3002 Benidorm
Spain 3001 Gijón
Spain 3018 Granada
Spain 3025 Jaen
Spain 3020 Las Palmas
Spain 3021 León
Spain 3015 Madrid
Spain 3022 Madrid
Spain 3009 Palma De Mallorca Mallorca
Spain 3017 Pamplona
Spain 3013 Santander
Spain 3007 Sevilla
Spain 3010 Terrassa
Spain 3003 Valencia
Spain 3004 Valencia
Sweden 6008 Linköping
Sweden 6007 Malmö
Sweden 6005 Norrköping
Sweden 6004 Örebro
Sweden 6001 Stockholm
Sweden 6003 Trollhättan
Sweden 6006 Umeå
Sweden 6002 Uppsala
Switzerland 2009 Baden
Switzerland 2001 Bern
Switzerland 2002 Frauenfeld
Switzerland 2003 Zurich
United Kingdom 7002 Bradford
United Kingdom 7003 Hull
United Kingdom 7001 Leicester
United Kingdom 7005 Nottingham

Sponsors (1)

Lead Sponsor Collaborator
Vifor (International) Inc.

Countries where clinical trial is conducted

Germany,  Italy,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of CKD-aP in HD patients Percentage (%) A 7-month study timeline
Secondary The prevalence of CKD-aP by severity none, mild, moderate, and severe A 7-month study timeline
See also
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