Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-31 @ 4:55 PM
Study NCT ID:
NCT01753232
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'C563617', 'term': 'Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Low Density Lipoprotein (LDL)-Concentration', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Data are only recorded for visits with lab results'}], 'secondaryOutcomes': [{'measure': 'Blood/plasma volume treated', 'timeFrame': 'Every two weeks to every three months for 24 months'}, {'measure': 'Number of occurence of adverse and serious adverse device effects', 'timeFrame': '24 months'}, {'measure': 'Change of Lipoprotein(a)-concentration', 'timeFrame': 'Pre/post treatment over 24 months, once per month or every 3 months', 'description': 'Only in patients with isolated Lp(a) increase'}, {'measure': 'Change of total cholesterol', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results'}, {'measure': 'Change of High Density Lipoprotein (HDL)-concentration', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results'}, {'measure': 'Change of triglyceride-concentration', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results'}, {'measure': 'Change in blood count', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results'}, {'measure': 'Change of fibrinogen-concentration', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results'}, {'measure': 'Change of creatinine-concentration', 'timeFrame': 'Every two weeks to every three months for 24 months'}, {'measure': 'Change of Immunoglobulins (Ig)', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results, Immunoglobulin (Ig) G, IgA and IgM if measured. In MONET patients only.'}, {'measure': 'Change in C Reactive Protein (CRP)-concentration', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results'}, {'measure': 'Change of blood pressure and heart rate', 'timeFrame': 'Every two weeks to every three months for 24 months', 'description': 'Only for treatment sessions with lab results'}, {'measure': 'Blood or plasma flow', 'timeFrame': 'Every two weeks to every three months for 24 months'}, {'measure': 'Anticoagulation regime', 'timeFrame': 'Every two weeks to every three months for 24 months'}, {'measure': 'Treatment time', 'timeFrame': 'Every two weeks to every three months for 24 months'}, {'measure': 'Medication', 'timeFrame': 'Every two weeks to every three months for 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DALI adsorber', 'MONET lipoprotein filter'], 'conditions': ['Hypercholesterolemia, Familial', 'LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA']}, 'descriptionModule': {'briefSummary': "Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.", 'detailedDescription': 'Data were recorded from patients suffering from familial hypercholesterolemia and treated by lipid apheresis using one of the two systems investigated for at least 3 months prior to inclusion in the study. Only those treatments were documented in which routine blood samples for laboratory analysis were taken, or in which adverse or serious adverse device effects occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* given informed consent\n* 18 years or older\n* patient compliant to therapy as prescribed\n* at least two therapy sessions per month\n* treatment with DALI or MONET system for at least 3 months before inclusion\n* last severe invasive intervention in hospital more than 3 months ago\n\nExclusion Criteria:\n\n* earlier participation in the study\n* unconscious patient/persons without capacity to contract\n* for DALI: intake of ACE-inhibitors'}, 'identificationModule': {'nctId': 'NCT01753232', 'acronym': 'LINET', 'briefTitle': 'Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': 'Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter', 'orgStudyIdInfo': {'id': 'TA-DALI-MONET-01-D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DALI-adsorber, hypercholesterolemia', 'description': 'Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system', 'interventionNames': ['Device: DALI-adsorber']}, {'label': 'MONET-Filter, hypercholesterolemia', 'description': 'Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter', 'interventionNames': ['Device: MONET-Lipoprotein filter']}], 'interventions': [{'name': 'DALI-adsorber', 'type': 'DEVICE', 'description': 'Recording of treatment data. No extra interventional treatment', 'armGroupLabels': ['DALI-adsorber, hypercholesterolemia']}, {'name': 'MONET-Lipoprotein filter', 'type': 'DEVICE', 'description': 'Only treatment data recording. No extra interventional treatment', 'armGroupLabels': ['MONET-Filter, hypercholesterolemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68309', 'city': 'Mannheim', 'state': 'Baden Würtemberg', 'country': 'Germany', 'facility': 'Nierenzentrum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '87439', 'city': 'Kempten (Allgäu)', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Medizinisches Versorgungszentrum', 'geoPoint': {'lat': 47.72674, 'lon': 10.31389}}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '14482', 'city': 'Potsdam', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Dialysezentrum Potsdam', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Nephrologisches Zentrum Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '18059', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Apheresezentrum Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '51105', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45127', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '55218', 'city': 'Ingelheim', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Apheresezentrum Ingelheim', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}, {'zip': '39108', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Dialysezentrum Magdeburg-Stattfeld', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}], 'overallOfficials': [{'name': 'Rainer Heinzler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann'}, {'name': 'Franz Heigl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum'}, {'name': 'Frank Leistikow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nierenzentrum Mannheim'}, {'name': 'Frido Himmelsbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Apheresezentrum Ingelheim'}, {'name': 'Ralf Spitthöver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum'}, {'name': 'Eberhard Roeseler, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort Heidering'}, {'name': 'Volker Schettler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrologisches Zentrum Goettingen'}, {'name': 'Gerd Schmitz, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Regensburg Department Clinical Chemistry and Laboratory Medicine'}, {'name': 'Nadim Abduhl-Rahman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dialysezentrum Magdeburg-Stadtfeld'}, {'name': 'Jens Ringel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dialysezentrum Potsdam'}, {'name': 'Wolfgang Ramlow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Apheresezentrum Rostock'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care Deutschland GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}