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

Chronic Kidney Disease-associated Pruritus Clinical Trial

— CKD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05625542
• Other study ID #: CS-DFK-2022-0027
• Status: Withdrawn
• Start date: June 10, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Vifor Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2023
• Est. primary completion date: June 10, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease-associated Pruritus
• Kidney Diseases
• Pruritus
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vifor (International) Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape	in the management of CKD-aP	Day 1
Secondary	Impact of pruritus severity (WI-NRS)on HRQoL,	as reported by patients	Day 1
Secondary	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
Secondary	Clinical and healthcare resource outcomes in the last 12 months.	Missed or additional dialysis sessions, Hospitalizations, etc.	Day 1