Chronic Kidney Disease-associated PruritusCKD-APNCT07370961
Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psychological) in the Treatment of Chronic Kidney Disease-Associated Pruritus
A study testing Structured psychological intervention in people with Chronic Kidney Disease-associated Pruritus, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease-associated Pruritus
- What is being tested?
- Structured psychological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CKD-aP: Diagnosis and Treatment Through a Multidisciplinary Approach - Pilot Study
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.
- Being tested
- Structured psychological intervention
- Keywords
- Chronic Kidney Disease-associated Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured psychological interventionOther
Structured psychological intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | standard of care alone |
| Intervention | Experimental | standard of care plus a structured psychological intervention Receives: Other: Structured psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease-associated PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Alberici, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370961
- Sponsor's protocol ID
- NP 6183
- Acronym
- CKD-AP
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CKD-aP: Diagnosis and Treatment Through a Multidisciplinary Approach - Pilot Study
- ClinicalTrials.gov ID
- NCT07370961
- Acronym / sponsor ID
- CKD-AP / NP 6183
- Keywords
- Chronic Kidney Disease-associated Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –standard of care alone |
| Intervention | Experimental | Other: Structured psychological interventionstandard of care plus a structured psychological intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured psychological interventionStructured psychological intervention | Other | Intervention |
Primary outcome
Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire.
Time frame: 6 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured psychological intervention in people with Chronic Kidney Disease-associated Pruritus, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.