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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease-associated Pruritus

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 Type: Observational
• Enrollment (Actual): 3100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of CKD-aP in HD patients	Percentage (%)	A 7-month study timeline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of CKD-aP by severity	none, mild, moderate, and severe	A 7-month study timeline

Collaborators and Investigators

• Sponsor: Vifor (International) Inc.
• Investigators: Principal Investigator: James Burton, Prof., University of Leicester Leicester, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: CKD; CKD-AP; CKD associated pruritus
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Skin Manifestations; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Pruritus
• Other Study ID Numbers: CS-DFK-2021-0712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing 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

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No