RELIEF CENSUS-US: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Prevalence (%) of CKD-aP patients undergoing HD based on the WI-NRS score (past 24 hours).
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients receiving HD at home or both home and site
结局指标
主要结局
Prevalence (%) of CKD-aP patients undergoing HD based on the WI-NRS score (past 24 hours).
时间窗: 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.
次要结局
- Impact of pruritus severity (WI-NRS)on HRQoL,(Day 1)
- Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape(Day 1)
- Clinical and healthcare resource outcomes in the last 12 months.(Day 1)
- Patient-reported communication with physician and other healthcare provider with respect to pruritus, as well as self-reported anti-itch treatments.(Day 1)
- Prevalence (%) of patients undergoing HD with various CKD-aP severities based on the WI-NRS score (past 24 hours).(Day 1)