Clinical trial NCT05524467: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
Official title: RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease-associated Pruritus
Keywords: CKD
CKD-AP
CKD associated pruritus
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 3100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of CKD-aP in HD patients
timeFrame: A 7-month study timeline
Secondary outcomes:
measure: The prevalence of CKD-aP by severity
timeFrame: A 7-month study timeline
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: 1113
city: Balingen
country: Germany
facility: 1011
city: Braunschweig
country: Germany
facility: 1007
city: Einbeck
country: Germany
facility: 1016
city: Eisenach
country: Germany
facility: 1012
city: Flensburg
country: Germany
facility: 1043
city: Freiburg
country: Germany
facility: 1048
city: Freiburg
country: Germany
facility: 1049
city: Hanover
country: Germany
facility: 1046
city: Herne
country: Germany
facility: 1001
city: Kiel
country: Germany
facility: 1035
city: Leipzig
country: Germany
facility: 1111
city: Mainz
country: Germany
facility: 1013
city: Saalfeld/Saale
country: Germany
facility: 1047
city: Sömmerda
country: Germany
facility: 1053
city: Witten
country: Germany
facility: 1044
city: Wuppertal
country: Germany
facility: 1051
city: Acquaviva Delle Fonti
country: Italy
facility: 4027
city: Bari
country: Italy
facility: 4015
city: Civitavecchia
country: Italy
facility: 4010
city: Firenze
country: Italy
facility: 4001
city: L'Aquila
country: Italy
facility: 4016
city: Lecce
country: Italy
facility: 4005
city: Macerata
country: Italy
facility: 4008
city: Mestre
country: Italy
facility: 4023
city: Milano
country: Italy
facility: 4006
city: Milano
country: Italy
facility: 4018
city: Milano
country: Italy
facility: 4021
city: Modena
country: Italy
facility: 4011
city: Monza
country: Italy
facility: 4009
city: Palermo
country: Italy
facility: 4003
city: Parma
country: Italy
facility: 4017
city: Pavia
country: Italy
facility: 4006
city: Pisa
country: Italy
facility: 4028
city: Pistoia
country: Italy
facility: 4002
city: Reggio Calabria
country: Italy
facility: 4026
city: Roma
country: Italy
facility: 4014
city: Rome
country: Italy
facility: 4024
city: Treviso
country: Italy
facility: 4022
city: Trieste
country: Italy
facility: 4030
city: Verona
country: Italy
facility: 4012
city: Viterbo
country: Italy
facility: 4025
city: Cascais
country: Portugal
facility: 5014
city: Faro
country: Portugal
facility: 5001
city: Gandra
country: Portugal
facility: 5013
city: Gondomar
country: Portugal
facility: 5011
city: Leiria
country: Portugal
facility: 5006
city: Porto
country: Portugal
facility: 5008
city: Sacavém
country: Portugal
facility: 5002
city: Palma De Mallorca
country: Spain
facility: 3009
state: Mallorca
city: Almería
country: Spain
facility: 3006
city: Barcelona
country: Spain
facility: 3005
city: Barcelona
country: Spain
facility: 3011
city: Barcelona
country: Spain
facility: 3012
city: Barcelona
country: Spain
facility: 3026
city: Benidorm
country: Spain
facility: 3002
city: Cadiz
country: Spain
facility: 3008
city: Gijón
country: Spain
facility: 3001
city: Granada
country: Spain
facility: 3018
city: Jaen
country: Spain
facility: 3025
city: Las Palmas
country: Spain
facility: 3020
city: León
country: Spain
facility: 3021
city: Madrid
country: Spain
facility: 3015
city: Madrid
country: Spain
facility: 3016
city: Madrid
country: Spain
facility: 3022
city: Madrid
country: Spain
facility: 3024
city: Pamplona
country: Spain
facility: 3017
city: Santander
country: Spain
facility: 3013
city: Sevilla
country: Spain
facility: 3007
city: Sevilla
country: Spain
facility: 3023
city: Terrassa
country: Spain
facility: 3010
city: Valencia
country: Spain
facility: 3003
city: Valencia
country: Spain
facility: 3004
city: Valencia
country: Spain
facility: 3027
city: Linköping
country: Sweden
facility: 6008
city: Malmö
country: Sweden
facility: 6007
city: Norrköping
country: Sweden
facility: 6005
city: Stockholm
country: Sweden
facility: 6001
city: Trollhättan
country: Sweden
facility: 6003
city: Umeå
country: Sweden
facility: 6006
city: Uppsala
country: Sweden
facility: 6002
city: Örebro
country: Sweden
facility: 6004
city: Baden
country: Switzerland
facility: 2009
city: Bern
country: Switzerland
facility: 2001
city: Frauenfeld
country: Switzerland
facility: 2002
city: Lugano
country: Switzerland
facility: 2004
city: Zurich
country: Switzerland
facility: 2003
city: Bradford
country: United Kingdom
facility: 7002
city: Hull
country: United Kingdom
facility: 7003
city: Leicester
country: United Kingdom
facility: 7001
city: London
country: United Kingdom
facility: 7006
city: London
country: United Kingdom
facility: 7007
city: Nottingham
country: United Kingdom
facility: 7005
city: Sheffield
country: United Kingdom
facility: 7004
Study officials:
affiliation: University of Leicester Leicester, United Kingdom
name: James Burton, Prof.
role: PRINCIPAL_INVESTIGATOR
References: