Chronic Kidney Disease-associated Pruritus
Conditions
Keywords
CKD, CKD-AP, CKD associated pruritus
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.
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).
Interventions
None listed
Sponsors
Vifor (International) Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed