Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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).
Study Design
Outcome Measures
Primary Outcome Measures
- Prevalence (%) of CKD-aP patients undergoing HD based on the WI-NRS score (past 24 hours). [Day 1]
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.
Secondary Outcome Measures
- Prevalence (%) of patients undergoing HD with various CKD-aP severities based on the WI-NRS score (past 24 hours). [Day 1]
none (0), mild (1-3), moderate (4-6), or severe (7-10) scores
- Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape [Day 1]
in the management of CKD-aP
- Impact of pruritus severity (WI-NRS)on HRQoL, [Day 1]
as reported by patients
- Patient-reported communication with physician and other healthcare provider with respect to pruritus, as well as self-reported anti-itch treatments. [Day 1]
Pruritus and anti-itch
- Clinical and healthcare resource outcomes in the last 12 months. [Day 1]
Missed or additional dialysis sessions, Hospitalizations, etc.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing informed consent
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Signed informed consent
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Able and willing to fill in questionnaires
Exclusion Criteria:
- Patients receiving HD at home or both home and site
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vifor (International) Inc.
Investigators
- Principal Investigator: Rajiv Agarwal, Dr, Indiana University, Indianapolis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS-DFK-2022-0027