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

Vifor

Status: Completed

Conditions: Chronic Kidney Disease-associated Pruritus

Study type: Observational

Funder types: Industry

Identifiers

NCT05524467

CS-DFK-2021-0712

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,100 participants in 1 patient group

Haemodialysis Patients

Description:

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