Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients

Chronic Kidney Disease-associated Pruritus Clinical Trial

— ReliefCensus  

Official title:

RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05524467
• Other study ID #: CS-DFK-2021-0712
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease-associated Pruritus
• Kidney Diseases
• Pruritus
• Renal Insufficiency, Chronic

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