Clinical trial NCT05625542: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
Official title: RELIEF CENSUS-US: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Kidney Disease-associated Pruritus
Keywords: CKD
CKD-AP
CKD associated pruritus
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will consist of a random selection of approximately 3,330 male or female adult patients (≥18 years) undergoing HD within two large dialysis organization (DO) networks.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence (%) of CKD-aP patients undergoing HD based on the WI-NRS score (past 24 hours).
timeFrame: Day 1
Secondary outcomes:
measure: Prevalence (%) of patients undergoing HD with various CKD-aP severities based on the WI-NRS score (past 24 hours).
timeFrame: Day 1
measure: Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape
timeFrame: Day 1
measure: Impact of pruritus severity (WI-NRS)on HRQoL,
timeFrame: Day 1
measure: Patient-reported communication with physician and other healthcare provider with respect to pruritus, as well as self-reported anti-itch treatments.
timeFrame: Day 1
measure: Clinical and healthcare resource outcomes in the last 12 months.
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: CSL Vifor
name: Despina Rüssmann, Dr
role: STUDY_CHAIR
References: