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

Completed

• Conditions: Chronic Kidney Disease-associated Pruritus

• Registration Number: NCT05524467
• Lead Sponsor: Vifor (International) Inc.

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.

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 Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-09-01
• Study Start: 2023-02-02
• Status Verified: 2023-12
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of CKD-aP in HD patients	A 7-month study timeline	Percentage (%)

Secondary Outcome Measures

Name	Time	Method
The prevalence of CKD-aP by severity	A 7-month study timeline	none, mild, moderate, and severe

Trial Locations

Locations (93)

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

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