Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT02687594
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599459', 'term': 'sucroferric oxyhydroxide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Drug Reactions (ADRs)', 'timeFrame': 'through study completion, up to 42 months'}, {'measure': 'Proportion of Adverse Drug Reactions (ADRs)', 'timeFrame': 'through study completion, up to 42 months'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire', 'timeFrame': 'through study completion, up to 42 months', 'description': 'Patient reported outcomes will be evaluated by descriptive statistics'}, {'measure': 'Patient Reported Outcome questionnaire - Perceived Pill based on the ACTG questionnaire', 'timeFrame': 'through study completion, up to 42 months', 'description': 'Patient reported outcomes will be evaluated by descriptive statistics'}, {'measure': 'Patient Reported Outcome questionnaire - Treatment satisfaction based on the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)', 'timeFrame': 'through study completion, up to 42 months', 'description': 'Patient reported outcomes will be evaluated by descriptive statistics'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal dialysis).\n\nIt is of major interest to observe the drug in daily use outside of controlled trial settings. The Marketing Authorisation Holder wishes to obtain further systematic data within a non-interventional study to investigate short and long-term safety.\n\nEffectiveness and Treatment adherence during real-life use will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Male or female patients with a diagnosis of hyperphosphataemia who are due to be treated with Velphoro according to the product's Summary of Product Characteristics (SmPC) are eligible for this non-interventional study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Signed informed consent\n* Indication for Velphoro treatment in accordance with the SmPC\n* Prevalent dialysis patients with a dialysis vintage of at least 6 months (HD or PD)\n* Treatment-naïve or pre-treated with anti-hyperphosphataemic therapy\n\nExclusion Criteria:\n\n* Prior participation in this NIS (Non-Interventional Study)\n* Parallel participation in an interventional study\n* Enrolment in a prior clinical trial with Velphoro'}, 'identificationModule': {'nctId': 'NCT02687594', 'acronym': 'VERIFIE', 'briefTitle': 'Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Fresenius Medical Care Renal Pharma'}, 'officialTitle': 'Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis or Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'VFMCRP-MEAF-PA21-01-EU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single group', 'description': 'sucroferric oxyhydroxide', 'interventionNames': ['Drug: sucroferric oxyhydroxide']}], 'interventions': [{'name': 'sucroferric oxyhydroxide', 'type': 'DRUG', 'otherNames': ['PA21 (Velphoro)'], 'description': 'The non-interventional design allows the observation of patients in a broad range of settings 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 a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.', 'armGroupLabels': ['single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier LYON-SUD', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '96450', 'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens Laiko', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '1007 MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospitals NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sebastian Walpen, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Vifor Fresenius Medical Care Renal Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vifor Fresenius Medical Care Renal Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}