NCT07370961Completed
Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psychological) in the Treatment of Chronic Kidney Disease-Associated Pruritus
CKD-aP: Diagnosis and Treatment Through a Multidisciplinary Approach - Pilot Study
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 19 Dec 2025
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Diseases
- Chronic kidney disease
- NCT number
- NCT07370961
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 1 Jun 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Severe mental illness or severe cognitive impairment (e.g. active psychosis, dementia, etc.)
Age
- Age < 18 years
Other
- Refusal to provide informed consent
- KDQOL-SF™ 1.3 score < 3
- Active substance abuse
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.