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

NCT05625542 | Withdrawn

• 1 other identifier: CS-DFK-2022-0027
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease-associated Pruritus

Keywords

CKD; CKD-AP; CKD associated pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Prevalence (%) of patients undergoing HD with various CKD-aP severities based on the WI-NRS score (past 24 hours).

  Day 1

• Current socio-demographic, clinical, and dialysis characteristics as well as current therapeutic landscape

  Day 1

• Impact of pruritus severity (WI-NRS)on HRQoL,

  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

• Clinical and healthcare resource outcomes in the last 12 months.

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male or female adult patients (≥18 years) undergoing HD
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients receiving HD at home or both home and site

Sponsors & Collaborators

• Vifor (International) Inc.: lead

Study Officials

• Despina Rüssmann, Dr

  CSL Vifor

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 23, 2022
• Study Start: June 10, 2023
• Primary Completion: June 10, 2023
• Study Completion: June 30, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.