Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT05524467
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of CKD-aP in HD patients', 'timeFrame': 'A 7-month study timeline', 'description': 'Percentage (%)'}], 'secondaryOutcomes': [{'measure': 'The prevalence of CKD-aP by severity', 'timeFrame': 'A 7-month study timeline', 'description': 'none, mild, moderate, and severe'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD', 'CKD-AP', 'CKD associated pruritus'], 'conditions': ['Chronic Kidney Disease-associated Pruritus']}, 'descriptionModule': {'briefSummary': 'Vifor International Inc. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.', 'detailedDescription': 'This is a non-interventional, cross-sectional, multicentre, and multinational (European) study. The non-interventional study (NIS) design allows the observation of patients in large haemodialysis (HD) centres reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by the sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.\n\nThe CENSUS-EU represents a cross-sectional study design of a representative selection of patients undergoing HD at 113 large dialysis centres across 7 countries in Europe. Prot. v.2.0, 9 May 2023'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The CENSUS-EU represents a cross-sectional study design of a representative selection of patients undergoing HD at 113 large dialysis centres across 7 countries in Europe. Prot. v.2.0, 9 May 2023', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing informed consent\n* Signed informed consent\n* Able and willing to fill in questionnaires\n\nExclusion Criteria:\n\n* Patients performing HD at home or both home and centre'}, 'identificationModule': {'nctId': 'NCT05524467', 'acronym': 'ReliefCensus', 'briefTitle': 'Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'RELIEF CENSUS-EU: Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients', 'orgStudyIdInfo': {'id': 'CS-DFK-2021-0712'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Haemodialysis Patients', 'description': 'Only one data collection timepoint per patient is planned. Eligible and consenting patients will be asked to complete several PROs and one questionnaire, and their respective medical charts will be assessed retrospectively'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aschaffenburg', 'country': 'Germany', 'facility': '1113', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'city': 'Balingen', 'country': 'Germany', 'facility': '1011', 'geoPoint': {'lat': 48.27525, 'lon': 8.85464}}, {'city': 'Braunschweig', 'country': 'Germany', 'facility': '1007', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'city': 'Einbeck', 'country': 'Germany', 'facility': '1016', 'geoPoint': {'lat': 51.82018, 'lon': 9.86961}}, {'city': 'Eisenach', 'country': 'Germany', 'facility': '1012', 'geoPoint': {'lat': 50.9807, 'lon': 10.31522}}, {'city': 'Flensburg', 'country': 'Germany', 'facility': '1043', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': '1048', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': '1049', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Hanover', 'country': 'Germany', 'facility': '1046', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Herne', 'country': 'Germany', 'facility': '1001', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'city': 'Kiel', 'country': 'Germany', 'facility': '1035', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': '1111', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mainz', 'country': 'Germany', 'facility': '1013', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Saalfeld', 'country': 'Germany', 'facility': '1047', 'geoPoint': {'lat': 50.64826, 'lon': 11.36536}}, {'city': 'Sömmerda', 'country': 'Germany', 'facility': '1053', 'geoPoint': {'lat': 51.15914, 'lon': 11.11524}}, {'city': 'Witten', 'country': 'Germany', 'facility': '1044', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}, {'city': 'Wuppertal', 'country': 'Germany', 'facility': '1051', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'city': 'Acquaviva delle Fonti', 'country': 'Italy', 'facility': '4027', 'geoPoint': {'lat': 40.89704, 'lon': 16.8433}}, {'city': 'Bari', 'country': 'Italy', 'facility': '4015', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Civitavecchia', 'country': 'Italy', 'facility': '4010', 'geoPoint': {'lat': 42.09325, 'lon': 11.79674}}, {'city': 'Florence', 'country': 'Italy', 'facility': '4001', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Lecce', 'country': 'Italy', 'facility': '4005', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'L’Aquila', 'country': 'Italy', 'facility': '4016', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'city': 'Macerata', 'country': 'Italy', 'facility': '4008', 'geoPoint': {'lat': 43.29789, 'lon': 13.45293}}, {'city': 'Mestre', 'country': 'Italy', 'facility': '4023', 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Milan', 'country': 'Italy', 'facility': '4006', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': '4018', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': '4021', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Modena', 'country': 'Italy', 'facility': '4011', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Monza', 'country': 'Italy', 'facility': '4009', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Palermo', 'country': 'Italy', 'facility': '4003', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Parma', 'country': 'Italy', 'facility': '4017', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Pavia', 'country': 'Italy', 'facility': '4006', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pisa', 'country': 'Italy', 'facility': '4028', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Pistoia', 'country': 'Italy', 'facility': '4002', 'geoPoint': {'lat': 43.93064, 'lon': 10.92365}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'facility': '4026', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Roma', 'country': 'Italy', 'facility': '4014', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rome', 'country': 'Italy', 'facility': '4024', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Treviso', 'country': 'Italy', 'facility': '4022', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Trieste', 'country': 'Italy', 'facility': '4030', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Verona', 'country': 'Italy', 'facility': '4012', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Viterbo', 'country': 'Italy', 'facility': '4025', 'geoPoint': {'lat': 42.41937, 'lon': 12.1056}}, {'city': 'Cascais', 'country': 'Portugal', 'facility': '5014', 'geoPoint': {'lat': 38.69681, 'lon': -9.42147}}, {'city': 'Faro', 'country': 'Portugal', 'facility': '5001', 'geoPoint': {'lat': 37.01869, 'lon': -7.92716}}, {'city': 'Gandra', 'country': 'Portugal', 'facility': '5013', 'geoPoint': {'lat': 41.20116, 'lon': -8.43376}}, {'city': 'Gondomar', 'country': 'Portugal', 'facility': '5011', 'geoPoint': {'lat': 41.14454, 'lon': -8.53223}}, {'city': 'Leiria', 'country': 'Portugal', 'facility': '5006', 'geoPoint': {'lat': 39.74362, 'lon': -8.80705}}, {'city': 'Porto', 'country': 'Portugal', 'facility': '5008', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Sacavém', 'country': 'Portugal', 'facility': '5002', 'geoPoint': {'lat': 38.79202, 'lon': -9.10801}}, {'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': '3009', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Almería', 'country': 'Spain', 'facility': '3006', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '3005', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '3011', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '3012', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '3026', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Benidorm', 'country': 'Spain', 'facility': '3002', 'geoPoint': {'lat': 38.53816, 'lon': -0.13098}}, {'city': 'Cadiz', 'country': 'Spain', 'facility': '3008', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Gijón', 'country': 'Spain', 'facility': '3001', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'city': 'Granada', 'country': 'Spain', 'facility': '3018', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Jaén', 'country': 'Spain', 'facility': '3025', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'city': 'Las Palmas', 'country': 'Spain', 'facility': '3020', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'city': 'León', 'country': 'Spain', 'facility': '3021', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '3015', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '3016', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '3022', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '3024', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': '3017', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Santander', 'country': 'Spain', 'facility': '3013', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Seville', 'country': 'Spain', 'facility': '3007', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': '3023', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Terrassa', 'country': 'Spain', 'facility': '3010', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'city': 'Valencia', 'country': 'Spain', 'facility': '3003', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': '3004', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': '3027', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': '6008', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': '6007', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Norrköping', 'country': 'Sweden', 'facility': '6005', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'city': 'Örebro', 'country': 'Sweden', 'facility': '6004', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': '6001', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Trollhättan', 'country': 'Sweden', 'facility': '6003', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': '6006', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': '6002', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Baden', 'country': 'Switzerland', 'facility': '2009', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': '2001', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Frauenfeld', 'country': 'Switzerland', 'facility': '2002', 'geoPoint': {'lat': 47.55776, 'lon': 8.89893}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': '2004', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': '2003', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Bradford', 'country': 'United Kingdom', 'facility': '7002', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'city': 'Hull', 'country': 'United Kingdom', 'facility': '7003', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': '7001', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': '7006', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': '7007', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': '7005', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': '7004', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'James Burton, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leicester Leicester, United Kingdom'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.\n\nData will be indefinitely available for requesting', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vifor (International) Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}