Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psychological) in the Treatment of Chronic Kidney Disease-Associated Pruritus

NCT07370961 | Completed

• 1 other identifier: NP 6183
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, pilot, randomized, open-label, non-profit interventional study designed to evaluate the impact of a multidisciplinary approach on chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing chronic extracorporeal hemodialysis. Twenty adult, clinically stable hemodialysis patients with moderate to severe uremic pruritus will be enrolled and randomized to receive either standard of care alone or standard of care plus a structured psychological intervention. The primary objective is to assess the change in pruritus-related quality of life after 6 months, measured by the KDQOL-SF questionnaire. Secondary objectives include evaluation of pruritus severity, quality of life, sleep quality, psychological distress, patient engagement, clinical and biochemical parameters, and exploration of patients' psychological experience over time. The study aims to provide preliminary evidence on the effectiveness of integrating psychological support into the management of CKD-associated pruritus in the hemodialysis population.

Conditions

Chronic Kidney Disease-associated Pruritus

Keywords

Chronic Kidney Disease-associated Pruritus

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire.

  Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire. This item assesses how bothersome pruritus is, on a scale ranging from 1 (not bothered at all) to 5 (extremely bothered).

  6 months

Study Arms (2)

Control

NO INTERVENTION

standard of care alone

Intervention

EXPERIMENTAL

standard of care plus a structured psychological intervention

Other: Structured psychological intervention

Interventions

Structured psychological intervention OTHER

Structured psychological intervention

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• KDQOL-SF™ 1.3 score ≥ 3 (corresponding to the presence of the symptom in the last 4 weeks, rated as "moderately bothered")
• On chronic hemodialysis for at least 3 months and clinically stable
• Signed informed consent for participation in the study

You may not qualify if:

• Refusal to provide informed consent
• Age \< 18 years
• KDQOL-SF™ 1.3 score \< 3
• Pruritus secondary to dermatologic diseases, autoimmune diseases with skin involvement (e.g. SLE, scleroderma, vasculitis, etc.), hepatobiliary diseases causing cholestatic jaundice, malignancies, or uncontrolled endocrine disorders
• Active substance abuse
• Severe mental illness or severe cognitive impairment (e.g. active psychosis, dementia, etc.)

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

ASST Spedali Civili di Brescia

Brescia, Italy, 25123, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 27, 2026
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)