ClinicalTrials.gg
CompletedNCT05524467ReliefCensusUpdated Jul 9, 2024

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

An observational study in Chronic Kidney Disease-associated Pruritus, sponsored by Vifor (International) Inc.. Completed at 94 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by Vifor (International) Inc. (part of CSL Limited) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
3,100
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Chronic Kidney Disease-associated Pruritus

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Keywords

  • CKD
  • CKD-AP
  • CKD associated pruritus
03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's enrollment of 3,100 is above the median of 128 across 48 observational studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Vifor (International) Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

First submitted after Vifor (International) Inc. became part of CSL Limited.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing
  • Signed informed consent
  • Able and willing to fill in questionnaires

Exclusion criteria

Exclusion Criteria:

  • Patients performing HD at home or both home and centre
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
3,100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Prevalence of CKD-aP in HD patients

    Percentage (%)

    Time frame: A 7-month study timeline

Secondary outcomes

  1. The prevalence of CKD-aP by severity

    none, mild, moderate, and severe

    Time frame: A 7-month study timeline

07

Study locations

94 sites
  • 1113
    Aschaffenburg, Germany
  • 1011
    Balingen, Germany
  • 1007
    Braunschweig, Germany
  • 1016
    Einbeck, Germany
  • 1012
    Eisenach, Germany
  • 1043
    Flensburg, Germany
  • 1048
    Freiburg, Germany
  • 1049
    Freiburg, Germany
  • 1046
    Hanover, Germany
  • 1001
    Herne, Germany
  • 1035
    Kiel, Germany
  • 1111
    Leipzig, Germany
  • 1013
    Mainz, Germany
  • 1047
    Saalfeld/Saale, Germany
  • 1053
    Sömmerda, Germany
  • 1044
    Witten, Germany
  • 1051
    Wuppertal, Germany
  • 4027
    Acquaviva Delle Fonti, Italy
  • 4015
    Bari, Italy
  • 4010
    Civitavecchia, Italy
  • 4001
    Firenze, Italy
  • 4016
    L'Aquila, 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
  • 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
    Jaen, 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
    Sevilla, Spain
  • 3023
    Sevilla, Spain
  • 3010
    Terrassa, Spain
  • 3003
    Valencia, Spain
  • 3004
    Valencia, Spain
  • 3027
    Valencia, Spain
  • 6008
    Linköping, Sweden
  • 6007
    Malmö, Sweden
  • 6005
    Norrköping, Sweden
  • 6001
    Stockholm, Sweden
  • 6003
    Trollhättan, Sweden
  • 6006
    Umeå, Sweden
  • 6002
    Uppsala, Sweden
  • 6004
    Örebro, 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
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05524467
Responsible party
Sponsor
First posted
Sep 1, 2022
Start date
Feb 2, 2023
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024
Last update
Jul 9, 2024

Study contacts

James Burton, Prof.
principal investigator · University of Leicester Leicester, United Kingdom

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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