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

Study Overview
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Brief Summary
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Vifor International Ltd. 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
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CKD-aP is a global clinical problem, and finding effective treatment remains a therapeutic challenge because of its complex pathophysiology (Sommer 2007, Weisshaar 2019, Yosipovitch 2013). The association between CKD-aP and clinical features and laboratory data remains unclear (Davison 2021, Manenti 2021). CKD-aP is thought to be associated with several conditions, including vitamin D deficiency, metabolic abnormalities (e.g., abnormal serum calcium or phosphate levels), toxin build-up, peripheral neuropathy, immune system dysregulation, or opioid receptor dysregulation (Jung 2015, Xie 2021, Kremer 2019, Verduzco 2020, Swarna 2019, Manenti 2021). At present, there is no systematic assessment of CKD-aP in routine clinical practice, and the prevalence of CKD-aP is generally under-reported by patients and therefore underestimated by as much as 69% of healthcare professionals (HCPs) (Rayner 2017). Alleviating the burden of CKD-aP requires proactive identification of patients who suffer from it (Sukul 2020, Davison 2015, Phan 2012).

Official Title
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RELIEF CENSUS-US: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients

Conditions
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Chronic Kidney Disease-associated Pruritus

Participation Criteria
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Eligibility Criteria
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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 receiving HD at home or both home and site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence (%) of CKD-aP patients undergoing HD based on the WI-NRS score (past 24 hours). | Ratio between the overall number of patients with WI-NRS scores ranging from 1-10 and the overall number of patients with WI-NRS scores ranging from 0-10, from patients randomly selected to participate in the study. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence (%) of patients undergoing HD with various CKD-aP severities based on the WI-NRS score (past 24 hours). | none (0), mild (1-3), moderate (4-6), or severe (7-10) scores | Day 1 | 
| Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape | in the management of CKD-aP | Day 1 | 
| Impact of pruritus severity (WI-NRS)on HRQoL, | as reported by patients | Day 1 | 
| Patient-reported communication with physician and other healthcare provider with respect to pruritus, as well as self-reported anti-itch treatments. | Pruritus and anti-itch | Day 1 | 
| Clinical and healthcare resource outcomes in the last 12 months. | Missed or additional dialysis sessions, Hospitalizations, etc. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, CKD-AP, CKD associated pruritus