Chronic Kidney Disease-associated PruritusReliefCensusNCT05524467
Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
An observational study of Chronic Kidney Disease-associated Pruritus, run by Vifor (International) Inc. at 94 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease-associated Pruritus
- How many people
- 3,100 participants
- Where
- 94 sitesin 7 countries
- Study dates
- 2 Feb 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients performing HD at home or both home and centre
Trial locations and contacts
94 sites in 7 countries.
94 sites in 7 countries
Italy25 sites
4027
Acquaviva delle Fonti
4015
Bari
4010
Civitavecchia
4001
Florence
4016
L’Aquila
4005
Lecce
4023
Mestre
4006
Milan
4018
Milan
4021
Milan
4011
Modena
4009
Monza
4003
Palermo
4017
Parma
4006
Pavia
4028
Pisa
4002
Pistoia
4008
Province of Macerata
4026
Reggio Calabria
4014
Roma
4024
Rome
4022
Treviso
4030
Trieste
4012
Verona
4025
Viterbo
Spain25 sites
3006
Almería
3005
Barcelona
3011
Barcelona
3012
Barcelona
3026
Barcelona
3002
Benidorm
3008
Cadiz
3001
Gijón
3018
Granada
3025
Jaén
3020
Las Palmas
3021
León
3015
Madrid
3016
Madrid
3022
Madrid
3024
Madrid
3009
Palma de Mallorca, Mallorca
3017
Pamplona
3013
Santander
3007
Seville
3023
Seville
3010
Terrassa
3003
Valencia
3004
Valencia
3027
Valencia
Germany17 sites
1113
Aschaffenburg
1011
Balingen
1007
Braunschweig
1016
Einbeck
1012
Eisenach
1043
Flensburg
1048
Freiburg im Breisgau
1049
Freiburg im Breisgau
1046
Hanover
1001
Herne
1035
Kiel
1111
Leipzig
1013
Mainz
1047
Saalfeld
1053
Sömmerda
1044
Witten
1051
Wuppertal
Sweden8 sites
6008
Linköping
6007
Malmö
6005
Norrköping
6004
Örebro
6001
Stockholm
6003
Trollhättan
6006
Umeå
6002
Uppsala
Portugal7 sites
5014
Cascais
5001
Faro
5013
Gandra
5011
Gondomar
5006
Leiria
5008
Porto
5002
Sacavém
United Kingdom7 sites
7002
Bradford
7003
Hull
7001
Leicester
7006
London
7007
London
7005
Nottingham
7004
Sheffield
Switzerland5 sites
2009
Baden
2001
Bern
2002
Frauenfeld
2004
Lugano
2003
Zurich
About this study
Official title: RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
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.
Read the 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
- Keywords
- CKD, CKD-AP, CKD associated pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CKD-aP in HD patients
Percentage (%)
Measured: A 7-month study timeline
Secondary outcomes (1)
The prevalence of CKD-aP by severity
none, mild, moderate, and severe
Measured: A 7-month study timeline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start2 Feb 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease-associated PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor (International) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Burton, Prof., Principal investigator, University of Leicester Leicester, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524467
- Sponsor's protocol ID
- CS-DFK-2021-0712
- Acronym
- ReliefCensus
- Status last verified
- Dec 2023
- First submitted
- 29 Aug 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Burton JO, Gallieni MA, Jacobson SH, Molina P, Westhoff TH, Perrin A, Ruessmann D. Prevalence and burden of chronic kidney disease-associated pruritus in Europe (CENSUS-EU). J Nephrol. 2026 Jun 15:aajag038. doi: 10.1093/joneph/aajag038. Online ahead of print.
PubMed 42290117Helou N, Nobre D, Corre T, Bonny O, Chazot R, Cherpillod A, De Seigneux S, Fumeaux D, Fumeaux Z, Humbert A, Jaques D, Hemett OM, Mehier P, Nowak G, Phan O, Reboux AH, Rossier A, Seydtaghia F, Teta D, Vogel G, Pruijm M. Prevalence, severity, and determinants of CKD-associated pruritus in a Swiss hemodialysis population with widespread use of hemodiafiltration: a cross-sectional study. BMC Nephrol. 2025 Nov 17;26(1):640. doi: 10.1186/s12882-025-04570-w.
PubMed 41249950
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT05524467
- Acronym / sponsor ID
- ReliefCensus / CS-DFK-2021-0712
- Keywords
- CKD, CKD-AP, CKD associated pruritus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,100 participants (actual)
- Lead sponsor
- Vifor (International) Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients performing HD at home or both home and centre
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of CKD-aP in HD patients
Time frame: A 7-month study timeline
Percentage (%)
1 secondary outcome
The prevalence of CKD-aP by severity
Time frame: A 7-month study timeline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 42290117Burton JO, Gallieni MA, Jacobson SH, Molina P, Westhoff TH, Perrin A, Ruessmann D. Prevalence and burden of chronic kidney disease-associated pruritus in Europe (CENSUS-EU). J Nephrol. 2026 Jun 15:aajag038. doi: 10.1093/joneph/aajag038. Online ahead of print.
- Derived from this study: PubMed 41249950Helou N, Nobre D, Corre T, Bonny O, Chazot R, Cherpillod A, De Seigneux S, Fumeaux D, Fumeaux Z, Humbert A, Jaques D, Hemett OM, Mehier P, Nowak G, Phan O, Reboux AH, Rossier A, Seydtaghia F, Teta D, Vogel G, Pruijm M. Prevalence, severity, and determinants of CKD-associated pruritus in a Swiss hemodialysis population with widespread use of hemodiafiltration: a cross-sectional study. BMC Nephrol. 2025 Nov 17;26(1):640. doi: 10.1186/s12882-025-04570-w.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Burton, Prof. principal investigator
University of Leicester Leicester, United Kingdom
94 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease-associated Pruritus, run by Vifor (International) Inc. at 94 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Italy, Spain, Germany, Sweden, Portugal and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CKD-aP in HD patients (time frame: A 7-month study timeline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05524467, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.