Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:51 PM
Study NCT ID:
NCT07370961
Status:
COMPLETED
Last Update Posted:
2026-01-27
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psychological) in the Treatment of Chronic Kidney Disease-Associated Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '6 months', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease-associated Pruritus'], 'conditions': ['Chronic Kidney Disease-associated Pruritus']}, 'descriptionModule': {'briefSummary': "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.\n\nTwenty 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.\n\nThe study aims to provide preliminary evidence on the effectiveness of integrating psychological support into the management of CKD-associated pruritus in the hemodialysis population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* KDQOL-SF™ 1.3 score ≥ 3 (corresponding to the presence of the symptom in the last 4 weeks, rated as "moderately bothered")\n* On chronic hemodialysis for at least 3 months and clinically stable\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* Refusal to provide informed consent\n* Age \\< 18 years\n* KDQOL-SF™ 1.3 score \\< 3\n* 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\n* Active substance abuse\n* Severe mental illness or severe cognitive impairment (e.g. active psychosis, dementia, etc.)'}, 'identificationModule': {'nctId': 'NCT07370961', 'acronym': 'CKD-AP', 'briefTitle': 'Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psychological) in the Treatment of Chronic Kidney Disease-Associated Pruritus', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}, 'officialTitle': 'CKD-aP: Diagnosis and Treatment Through a Multidisciplinary Approach - Pilot Study', 'orgStudyIdInfo': {'id': 'NP 6183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'standard of care alone'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'standard of care plus a structured psychological intervention', 'interventionNames': ['Other: Structured psychological intervention']}], 'interventions': [{'name': 'Structured psychological intervention', 'type': 'OTHER', 'description': 'Structured psychological intervention', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'state': 'Italy', 'country': 'Italy', 'facility': 'ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Federico Alberici', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}}}}