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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Disease-associated Pruritus

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 Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vifor (International) Inc.
• Investigators: Study Chair: Despina Rüssmann, Dr, CSL Vifor

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Actual): June 10, 2023
• Study Completion (Estimated): June 30, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: CKD; CKD-AP; CKD associated pruritus
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Skin Manifestations; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Pruritus
• Other Study ID Numbers: CS-DFK-2022-0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
• IPD Sharing Time Frame: Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No