Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 4:55 AM
Study NCT ID:
NCT05282732
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2022-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily values for urea, Unit: mg/dl or mmol/L', 'timeFrame': 'During the intervention', 'description': 'Acute haemodialysis patients'}, {'measure': 'Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L', 'timeFrame': 'During the intervention', 'description': 'Acute haemodialysis patients'}, {'measure': 'Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L', 'timeFrame': 'During the intervention', 'description': 'Acute haemodialysis patients'}, {'measure': 'Ultrafiltration volume (UF) and Effluent volume (per treatment)', 'timeFrame': 'During the intervention', 'description': 'Acute haemodialysis patients'}, {'measure': 'Values for urea and creatinine (measured according to the clinical practice of the site)', 'timeFrame': 'During the intervention', 'description': 'Chronic haemodialysis patients'}, {'measure': 'Planned and delivered UF-volume (per treatment)', 'timeFrame': 'During the intervention', 'description': 'Chronic haemodialysis patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Genius system', 'Slow extended daily dialysis'], 'conditions': ['Renal Failure', 'End Stage Renal Disease', 'Acute Renal Failure']}, 'descriptionModule': {'briefSummary': 'Retrospective analysis of performance and treatment data collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter \\& Genius 90 Concentrates in acute haemodialysis, haemodynamically instable patients and chronic haemodialysis patients\n\n* to analyse performance and treatment data from patients treated with the investigational device\n* to evaluate the filter characteristics for aHD (Acute haemodialysis) patients\n* to evaluate the improvement of kidney function for aHD patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Haemodynamically instable patients in acute haemodialysis and chronic haemodialysis patients treatment with the Genius system', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with an indication for the extracorporeal blood treatment suffering from renal insufficiency who received all treatments, between January 2019 and December 2019, with the investigational devices have to be included in the study in chronological order.\n* For aHD patients: availability of at least 3 of the 5 primary variables (daily urea, creatinine, potassium, ultrafiltration and effluent volume) for 50 % of the documented treatments.\n* For cHD patients: availability of the ultrafiltration values for all treatments and at least one value for urea and creatinine per week\n\nExclusion Criteria:\n\n* Simultaneous use of another filter/adsorber for another form of therapy'}, 'identificationModule': {'nctId': 'NCT05282732', 'acronym': 'Genius', 'briefTitle': 'Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': 'Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Acute Haemodialysis, Haemodynamically Instable Patients and Chronic Haemodialysis Patients', 'orgStudyIdInfo': {'id': 'Genius-AKI-01-D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'aHD: Acute haemodialysis patients'}, {'label': 'cHD: Chronic haemodialysis patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernhard Schmidt, Prof.Dr.', 'role': 'CONTACT', 'email': 'Schmidt.Bernhard@mh-hannover.de'}], 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '07743', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Brauer Martin, Dr.', 'role': 'CONTACT', 'email': 'martin.brauer@med.uni-jena.de'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'centralContacts': [{'name': 'Tatiana De los Rios', 'role': 'CONTACT', 'email': 'Tatiana.De-Los-Rios@fmc-ag.com', 'phone': '+49 6172 608 2362'}, {'name': 'Jana Schmitt', 'role': 'CONTACT', 'email': 'Jana.Schmitt@fmc-ag.com', 'phone': '+49 6172 609 95403'}], 'overallOfficials': [{'name': 'Martin Brauer, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jena University Hospital'}, {'name': 'Bernhard Schmidt, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care Deutschland GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Alcedis GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}