Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-20 @ 3:37 AM
Study NCT ID:
NCT05415969
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CKD-aP Among Adults on Dialysis in Switzerland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of CKD-aP', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Evaluation of the presence of CKD-aP. This outcome prevalence will be reported in %.'}, {'measure': 'Severity of CKD-aP using the Visual Analog Scale', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Severity of CKD-aP will be measured using the Visual Analog Scale (VAS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours.\n\nThe VAS score ranges from 0 (not itchy) to 10 (extremely itchy); Severity will be classified into five categories: 1) 0 = no pruritus, 2) 0.1-2.9 points = mild pruritus, 3) 3.0-6.9 points = moderate pruritus, 4) 7.0-8.9 points = severe pruritus, and 5) 9.0-10.0 points = very severe pruritus. Higher scores indicate a worse outcome.'}, {'measure': 'Severity of CKD-aP using the Verbal Rating Scale', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Severity of CKD-aP will also be measured using the Verbal Rating Scale (VRS) questionnaire. Participants will be asked to rate their maximum pruritus intensity during the last 24 hours.\n\nThe VRS is a five-point scale and consists of a list of adjectives describing various levels of symptom intensity (0= no itch, 1= mild itch, 2= moderate itch, 3= severe itch and 4=very severe itch). Higher scores indicate a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Sodium level (mmol/l) in sweat', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Measurement of sodium (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.\n\n60 participants (30 cases and 30 controls)'}, {'measure': 'Chloride level (mmol/l) in sweat', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Measurement of chloride (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.\n\n60 participants (30 cases and 30 controls)'}, {'measure': 'Potassium level (mmol/l) in sweat', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Measurement of potassium (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.\n\n60 participants (30 cases and 30 controls)'}, {'measure': 'Calcium level (mg/l) in sweat', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Measurement of calcium (mg/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.\n\n60 participants (30 cases and 30 controls)'}, {'measure': 'Phosphorus level (mg/ml) in sweat', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Measurement of phosphorus (mg/ml) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.\n\n60 participants (30 cases and 30 controls)'}, {'measure': 'Urea level (mmol/l) in sweat', 'timeFrame': 'June 27, 2022- October 31, 2023', 'description': 'Measurement of urea (mmol/l) in a subgroup of patients with CKD-aP and their age-sex-matched controls on dialysis.\n\n60 participants (30 cases and 30 controls)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease; Dialysis; Pruritus'], 'conditions': ['Chronic Kidney Diseases', 'Dialysis', 'Chronic Kidney Diseases Associated Pruritus']}, 'descriptionModule': {'briefSummary': 'Chronic Kidney Disease Associated Pruritus (CKD-aP) represents a localized or a generalized skin itch, which is a common symptom occurring in end-stage renal disease and dialysis. The prevalence of CKD-aP in adults on dialysis varies between countries ranging between 20-42%. Swiss data on CKD-aP are unfortunately largely lacking, as Switzerland is so far not part of large registries, such as DOPPS.\n\nThe aging population, the increase in diabetes (69% by 2030), the increase in hypertension (60% by 2025) and poly-morbidity will probably lead to a rise in the number of patients on dialysis and subsequent CKD-aP.\n\nCKD-aP is associated with sleep disturbances, compromised quality of life, emotional distress, and increased risks of hospitalization and death. Its management lacks approaches that are supported by strong evidence because its pathogenesis remains poorly understood and may be related to an increase in uremic toxins, skin inflammation. In this context, sweat composition deserves more attention.\n\nAim of the study The aim of the study is to determine the prevalence of CKD-aP in the population on dialysis, the association between CKD-aP and different electrolytes, and the potential role of the composition of sweat in CKD-aP.\n\nResults will be used for building a CKD-aP symptom management program to improve the quality of care of patients on dialysis and will be incorporated in the nursing continuing education program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients on hemodialysis or peritoneal dialysis followed by nephrologists in private and public hospitals of the French speaking Part of Switzerland.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 18 years old\n* Diagnosed with end-stage renal disease and receiving hemodialysis for at least 6 months\n* Able to communicate in French or availability of a French-speaking close relative for translation\n* Signed informed consent\n\nAdditional inclusion criteria for the case-control study outcomes phase 2:\n\n* Reporting moderate to severe CKD-aP for the participant considered as a case\n* Reporting no or mild CKD-aP for the participant considered as a control Cases and controls will be matched by age-group, sex, and dialysis modality (hemodialysis or peritoneal dialysis).\n\nExclusion Criteria:\n\n* Presence of cognitive impairment or cognitive disorder'}, 'identificationModule': {'nctId': 'NCT05415969', 'acronym': 'UP-RAISE', 'briefTitle': 'CKD-aP Among Adults on Dialysis in Switzerland', 'organization': {'class': 'OTHER', 'fullName': 'University of Applied Sciences of Western Switzerland'}, 'officialTitle': 'Uremic Pruritus Among Adults on Dialysis in the French Speaking Part of Switzerland', 'orgStudyIdInfo': {'id': '2022-00670'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CKD-aP', 'type': 'OTHER', 'description': 'Identification of CKD-aP prevalence and severity among patients on dialysis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'University of Lausanne Hospitals', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymized Data can be shared upon justified request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Applied Sciences of Western Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, {'name': 'Hôpital Fribourgeois', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'Valais Hospital', 'class': 'UNKNOWN'}, {'name': 'eHnv Hospital', 'class': 'UNKNOWN'}, {'name': 'Rennaz Hospital', 'class': 'UNKNOWN'}, {'name': 'Intercantonal Hospital of Broye', 'class': 'UNKNOWN'}, {'name': 'GHOL Nyon Hospital', 'class': 'UNKNOWN'}, {'name': 'Dialyse Riviera', 'class': 'UNKNOWN'}, {'name': 'Cecil Clinic Hirslanden Private Hospital Group', 'class': 'UNKNOWN'}, {'name': 'Vifor Pharma', 'class': 'INDUSTRY'}, {'name': 'Réseau Hospitalier Neuchâtelois', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor UAS', 'investigatorFullName': 'Nancy Helou', 'investigatorAffiliation': 'University of Applied Sciences of Western Switzerland'}}}}