RELIEF CENSUS-EU
Research type
Research Study
Full title
RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
IRAS ID
320493
Contact name
James Burton
Contact email
Sponsor organisation
Vifor (International) Ltd.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT number, NCT05524467
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
Research Summary:
Chronic kidney disease associated pruritus (CKD-aP) is a highly prevalent condition in patients with advanced chronic kidney disease and end-stage renal disease receiving dialysis, regardless of age or sex. The estimated prevalence of CKD-aP is approximately 70% among patients undergoing hemodialisys. The true prevalence is, however, unknown because it is often under-reported by patients or not assessed by healthcare providers, partly due to the uncertainty regarding its pathogenesis.
Presenting as large symmetric reddened areas of skin, and often at night, CKD-aP significantly impacts the patient’s health-related quality of life, sleep quality, and mental health. Unmanaged CKD-aP is associated with a poor prognosis and represents a significant unmet need due to lack of treatment options.
This is a non-interventional, cross-sectional, multicentre, and multinational (European) study. The objectives of the "RELIEF CENSUS" study are to assess the epidemiology and prevalence of chronic kidney disease associated pruritus in patients undergoing hemodialysis in participating centres.
Up to 4,810 patients randomly selected will be invited to participate in the study which is planned to involve approximately 136 hemodialysis sites across several European countries.
In addition to the collection of data from patients medical charts, patients will be asked to complete 6 questionnaires during one of their routine hemodialysis visits.
The study design is cross-sectional in nature and hence will have only one data collection time point (the index date is the patient visit date when PROs are completed and could be the same as the informed consent date if the questionnaires are completed on the same day the informed consent is signed).Lay summary of study results: Study title: RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
Sponsor: Vifor (International) Ltd.
The overall aim of this study was to assess the epidemiology and prevalence of CKD-aP in a random selection of patients undergoing haemodialysis (HD) in participating centres across 7 countries in Europe.
Vifor (International) Ltd. was seeking real-world evidence (RWE) to better understand the prevalence, epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.
At the time of this study, routine screening is not well established in daily dialysis routine, and CKD-aP is generally under reported by patients and therefore underestimated by as much as 69% of healthcare professionals (HCPs). Alleviating the burden of CKD-aP requires proactive identification of patients who suffer from pruritus. In addition, untreated CKD-aP affects HRQoL significantly and therefore warrants detection.The primary objective was:
To estimate the prevalence of CKD-aP using the worst itch numeric rating scale (WI-NRS) patient-reported outcome (PRO) in the study population.
The secondary objectives were:
To estimate the prevalence of 4 categories of itch severity (no CKD-aP, mild CKD-aP, moderate CKD-aP, severe CKD-aP) using the WI-NRS [22–24]in the study population To describe the current socio-demographic, clinical, and dialysis characteristics as well as the current treatment landscape and management options using medical charts To describe the impact of CKD-aP on HRQoL using several validated PROs To describe to whom patients with CKD-aP communicate their concerns of pruritus/itch, when their itch started, and the anti-itch treatments currently used through a short, self-administered questionnaire To describe clinical and healthcare resource outcomes in the last 12 months (using medical charts) A total of 3,131 randomly selected adult patients undergoing HD were screened in the electronic data capture (EDC) system, and 3,095 were included in the All Enrolled Patients set. All enrolled patients consented to the study. After excluding screen failures, patients with missing WI-NRS scores, and patients with major protocol deviations, a total of 2,963 patients were included in the Full Analysis Set. Ninety-four centres were initiated, and 90 recruited at least 1 patient.
A 7-month data collection period was initially proposed, reflecting the time between site/centre activation, first patient in (FPI), and last patient in (LPI). This proposed timeline changed over time and was extended to 12 months in total to reach a representative number of patients, closer to the initial target. The enrolment started in February 2023 and ended end of January 2024.
Results from this non-interventional, cross-sectional, multicentre and multinational study, estimated a prevalence of CKD-aP in line with the current literature. Utilising a range of scales, findings suggest up to a third of patients experience moderate to severe itching, as well as impacts on HRQoL, highlighting the significant burden that pruritus has on patients undergoing HD.
The CSR has not been published yet but it will be presented at ERA 2025 (abstract in development) and at the World Congress on Itch 2025 (abstract in development).
For more details please refer to the CSR.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
22/YH/0264
Date of REC Opinion
3 Jan 2023
REC opinion
Further Information Favourable Opinion