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

NCT ID: NCT05524467

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-02

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease-associated Pruritus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vifor (International) Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James Burton, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Leicester Leicester, United Kingdom

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1113

Aschaffenburg, , Germany

Site Status

1011

Balingen, , Germany

Site Status

1007

Braunschweig, , Germany

Site Status

1016

Einbeck, , Germany

Site Status

1012

Eisenach, , Germany

Site Status

1043

Flensburg, , Germany

Site Status

1048

Freiburg im Breisgau, , Germany

Site Status

1049

Freiburg im Breisgau, , Germany

Site Status

1046

Hanover, , Germany

Site Status

1001

Herne, , Germany

Site Status

1035

Kiel, , Germany

Site Status

1111

Leipzig, , Germany

Site Status

1013

Mainz, , Germany

Site Status

1047

Saalfeld, , Germany

Site Status

1053

Sömmerda, , Germany

Site Status

1044

Witten, , Germany

Site Status

1051

Wuppertal, , Germany

Site Status

4027

Acquaviva delle Fonti, , Italy

Site Status

4015

Bari, , Italy

Site Status

4010

Civitavecchia, , Italy

Site Status

4001

Florence, , Italy

Site Status

4005

Lecce, , Italy

Site Status

4016

L’Aquila, , Italy

Site Status

4008

Macerata, , Italy

Site Status

4023

Mestre, , Italy

Site Status

4006

Milan, , Italy

Site Status

4018

Milan, , Italy

Site Status

4021

Milan, , Italy

Site Status

4011

Modena, , Italy

Site Status

4009

Monza, , Italy

Site Status

4003

Palermo, , Italy

Site Status

4017

Parma, , Italy

Site Status

4006

Pavia, , Italy

Site Status

4028

Pisa, , Italy

Site Status

4002

Pistoia, , Italy

Site Status

4026

Reggio Calabria, , Italy

Site Status

4014

Roma, , Italy

Site Status

4024

Rome, , Italy

Site Status

4022

Treviso, , Italy

Site Status

4030

Trieste, , Italy

Site Status

4012

Verona, , Italy

Site Status

4025

Viterbo, , Italy

Site Status

5014

Cascais, , Portugal

Site Status

5001

Faro, , Portugal

Site Status

5013

Gandra, , Portugal

Site Status

5011

Gondomar, , Portugal

Site Status

5006

Leiria, , Portugal

Site Status

5008

Porto, , Portugal

Site Status

5002

Sacavém, , Portugal

Site Status

3009

Palma de Mallorca, Mallorca, Spain

Site Status

3006

Almería, , Spain

Site Status

3005

Barcelona, , Spain

Site Status

3011

Barcelona, , Spain

Site Status

3012

Barcelona, , Spain

Site Status

3026

Barcelona, , Spain

Site Status

3002

Benidorm, , Spain

Site Status

3008

Cadiz, , Spain

Site Status

3001

Gijón, , Spain

Site Status

3018

Granada, , Spain

Site Status

3025

Jaén, , Spain

Site Status

3020

Las Palmas, , Spain

Site Status

3021

León, , Spain

Site Status

3015

Madrid, , Spain

Site Status

3016

Madrid, , Spain

Site Status

3022

Madrid, , Spain

Site Status

3024

Madrid, , Spain

Site Status

3017

Pamplona, , Spain

Site Status

3013

Santander, , Spain

Site Status

3007

Seville, , Spain

Site Status

3023

Seville, , Spain

Site Status

3010

Terrassa, , Spain

Site Status

3003

Valencia, , Spain

Site Status

3004

Valencia, , Spain

Site Status

3027

Valencia, , Spain

Site Status

6008

Linköping, , Sweden

Site Status

6007

Malmo, , Sweden

Site Status

6005

Norrköping, , Sweden

Site Status

6004

Örebro, , Sweden

Site Status

6001

Stockholm, , Sweden

Site Status

6003

Trollhättan, , Sweden

Site Status

6006

Umeå, , Sweden

Site Status

6002

Uppsala, , Sweden

Site Status

2009

Baden, , Switzerland

Site Status

2001

Bern, , Switzerland

Site Status

2002

Frauenfeld, , Switzerland

Site Status

2004

Lugano, , Switzerland

Site Status

2003

Zurich, , Switzerland

Site Status

7002

Bradford, , United Kingdom

Site Status

7003

Hull, , United Kingdom

Site Status

7001

Leicester, , United Kingdom

Site Status

7006

London, , United Kingdom

Site Status

7007

London, , United Kingdom

Site Status

7005

Nottingham, , United Kingdom

Site Status

7004

Sheffield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany Italy Portugal Spain Sweden Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CS-DFK-2021-0712

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.