Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 9:57 AM
Study NCT ID:
NCT07390604
Status:
COMPLETED
Last Update Posted:
2026-02-05
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case Series : Management of Elevated Lipoprotein(a) Using Double-Filtration Plasmapheresis (DFPP) in Hemodialysis Patients With Chronic Kidney Disease ; ( LiPo-A )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum Lp(a) concentration (nmol/L), on routine venous blood sampling', 'timeFrame': 'up to 15 months after inclusion', 'description': 'Before and after each DFPP session (repeated measures) during the study period'}], 'secondaryOutcomes': [{'measure': 'serum LDL and serum triglycerides concentration (g/L), on routine venous blood sampling', 'timeFrame': 'up to 15 months after inclusion', 'description': 'before and after each DFPP session (repeated measures) during the study period'}, {'measure': 'serum triglycerides concentration (g/L), on routine venous blood sampling', 'timeFrame': 'up to 15 months after inclusion', 'description': 'before and after each DFPP session (repeated measures) during the study period'}, {'measure': 'cardiovascular or thromboembolic events', 'timeFrame': 'during all the study period: up to 15 months after inclusion', 'description': 'Myocardial infarction, stroke, Deep vein thrombosis, Pulmonary embolism, Systemic arterial embolism, aortiques complictions, thrombosis, Based on patient questioning and clinical examination during routine follow-up consultations'}, {'measure': 'Hemodynamic status:blood pressure', 'timeFrame': 'up to 15 months after inclusion', 'description': "follow-up of patients' blood pressure (mmHg) before and after each DFPP session (repeated measures) during the study period"}, {'measure': 'Hemodynamic status: ultrafiltration rate', 'timeFrame': 'up to 15 months after inclusion', 'description': "follow-up of patients' ultrafiltration rate (grams) before and after each DFPP session (repeated measures) during the study period"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lipoprotein(a)', 'Lipoprotein-apheresis', 'Double-filtration Plasmapheresis', 'Hemodialysis Complication', 'End Stage Chronic Renal Failure']}, 'descriptionModule': {'briefSummary': 'Lipoprotein-apheresis DFPP has been performed in patients with Lp(a) levels greater than 125 nmol/L. In this report, data will be presented on five hemodialysis patients with significantly elevated Lp(a) levels (\\>200 nmol/L) who had a history of cardiovascular disease and notable thromboembolic events.', 'detailedDescription': 'The biological and clinical outcomes related to Lipoprotein-apheresis DFPP treatment and the associated cardiovascular and thromboembolic events will be described in these patients. Additionally, the impact of DFPP on biological and clinical markers including LDL cholesterol, triglycerides, fibrinogen, hemoglobin, platelet count, C-reactive protein (CRP), blood pressure, plasma volume treated, volume of albumin substitution, volume of plasma rejected, and duration of each Lipoprotein-apheresis DFPP session will be evaluated .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'chronic Hemodialsisi patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hemodialysis patients with elevated Lp(a) levels (\\>200 nmol/L) and a history of cardiovascular disease and/or thromboembolic events who underwent DFPP sessions as part of their management\n\nExclusion Criteria:\n\n* -Patients with progressive, active disease, presenting with severe general deterioration and a limited life expectancy\n* Patients presenting with hemodynamic instability\n* Patients presenting with acute kidney diseases.'}, 'identificationModule': {'nctId': 'NCT07390604', 'acronym': 'LiPo-A', 'briefTitle': 'Case Series : Management of Elevated Lipoprotein(a) Using Double-Filtration Plasmapheresis (DFPP) in Hemodialysis Patients With Chronic Kidney Disease ; ( LiPo-A )', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Case Series : Management of Elevated Lipoprotein(a) Using Double-Filtration Plasmapheresis (DFPP) in Hemodialysis Patients With Chronic Kidney Disease Clinical and Biological Outcomes in Patients at Cardiovascular and Thromboembolic Risk', 'orgStudyIdInfo': {'id': '2025-03Obs-CHRMT'}}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz-Thionville Hopital de Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}], 'overallOfficials': [{'name': 'Zead TUBAIL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz-Thionville Hopital de Mercy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}