Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
ReliefCensus
RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
1 other identifier
observational
3,100
7 countries
94
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Shorter than P25 for all trials
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedJuly 9, 2024
December 1, 2023
12 months
August 29, 2022
July 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of CKD-aP in HD patients
Percentage (%)
A 7-month study timeline
Secondary Outcomes (1)
The prevalence of CKD-aP by severity
A 7-month study timeline
Study Arms (1)
Haemodialysis Patients
Only one data collection timepoint per patient is planned. Eligible and consenting patients will be asked to complete several PROs and one questionnaire, and their respective medical charts will be assessed retrospectively
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients performing HD at home or both home and centre
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
1113
Aschaffenburg, Germany
1011
Balingen, Germany
1007
Braunschweig, Germany
1016
Einbeck, Germany
1012
Eisenach, Germany
1043
Flensburg, Germany
1048
Freiburg im Breisgau, Germany
1049
Freiburg im Breisgau, Germany
1046
Hanover, Germany
1001
Herne, Germany
1035
Kiel, Germany
1111
Leipzig, Germany
1013
Mainz, Germany
1047
Saalfeld, Germany
1053
Sömmerda, Germany
1044
Witten, Germany
1051
Wuppertal, Germany
4027
Acquaviva delle Fonti, Italy
4015
Bari, Italy
4010
Civitavecchia, Italy
4001
Florence, Italy
4005
Lecce, Italy
4016
L’Aquila, Italy
4008
Macerata, Italy
4023
Mestre, Italy
4006
Milan, Italy
4018
Milan, Italy
4021
Milan, Italy
4011
Modena, Italy
4009
Monza, Italy
4003
Palermo, Italy
4017
Parma, Italy
4006
Pavia, Italy
4028
Pisa, Italy
4002
Pistoia, Italy
4026
Reggio Calabria, Italy
4014
Roma, Italy
4024
Rome, Italy
4022
Treviso, Italy
4030
Trieste, Italy
4012
Verona, Italy
4025
Viterbo, Italy
5014
Cascais, Portugal
5001
Faro, Portugal
5013
Gandra, Portugal
5011
Gondomar, Portugal
5006
Leiria, Portugal
5008
Porto, Portugal
5002
Sacavém, Portugal
3009
Palma de Mallorca, Mallorca, Spain
3006
Almería, Spain
3005
Barcelona, Spain
3011
Barcelona, Spain
3012
Barcelona, Spain
3026
Barcelona, Spain
3002
Benidorm, Spain
3008
Cadiz, Spain
3001
Gijón, Spain
3018
Granada, Spain
3025
Jaén, Spain
3020
Las Palmas, Spain
3021
León, Spain
3015
Madrid, Spain
3016
Madrid, Spain
3022
Madrid, Spain
3024
Madrid, Spain
3017
Pamplona, Spain
3013
Santander, Spain
3007
Seville, Spain
3023
Seville, Spain
3010
Terrassa, Spain
3003
Valencia, Spain
3004
Valencia, Spain
3027
Valencia, Spain
6008
Linköping, Sweden
6007
Malmo, Sweden
6005
Norrköping, Sweden
6004
Örebro, Sweden
6001
Stockholm, Sweden
6003
Trollhättan, Sweden
6006
Umeå, Sweden
6002
Uppsala, Sweden
2009
Baden, Switzerland
2001
Bern, Switzerland
2002
Frauenfeld, Switzerland
2004
Lugano, Switzerland
2003
Zurich, Switzerland
7002
Bradford, United Kingdom
7003
Hull, United Kingdom
7001
Leicester, United Kingdom
7006
London, United Kingdom
7007
London, United Kingdom
7005
Nottingham, United Kingdom
7004
Sheffield, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
James Burton, Prof.
University of Leicester Leicester, United Kingdom
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2022
First Posted
September 1, 2022
Study Start
February 2, 2023
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
July 9, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
- Access Criteria
- A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.