Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-02 @ 10:09 AM
Study NCT ID:
NCT07141628
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Link between hyperlipoproteinemia A and a first event of cardiovascular death', 'timeFrame': '18 months', 'description': 'cardiovascular death: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a first event of myocardial infarction', 'timeFrame': '18 months', 'description': 'myocardial infarction: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a first event of stroke', 'timeFrame': '18 months', 'description': 'stroke: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4', 'timeFrame': '18 months', 'description': 'peripheral artery disease stage 4: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy', 'timeFrame': '18 months', 'description': 'initiation of renal replacement therapy: yes/no'}], 'secondaryOutcomes': [{'measure': 'Rate of hyperlipoproteinemia A', 'timeFrame': 'Baseline (Day 0)', 'description': 'defined as a lipoprotein A level \\> 125 nmol/L'}, {'measure': 'Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion', 'timeFrame': 'Baseline (Day 0)', 'description': 'Ischemic heart disease: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion', 'timeFrame': 'Baseline (Day 0)', 'description': 'Ischemic stroke: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion', 'timeFrame': 'Baseline (Day 0)', 'description': 'Calcified aortic stenosis: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a history of lower limb arterial disease stage 2-4 at inclusion', 'timeFrame': 'Baseline (Day 0)', 'description': 'Lower limb arterial disease stage 2-4: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a history of vascular nephropathy at inclusion', 'timeFrame': 'Baseline (Day 0)', 'description': 'Vascular nephropathy: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and a history of arterial angioplasty at any site at inclusion', 'timeFrame': 'Month 18', 'description': 'coronary artery or limb angioplasty: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and hospitalization for cardiac decompensation during follow-up', 'timeFrame': 'Month 18', 'description': 'hospitalization for cardiac decompensation: yes/no'}, {'measure': 'Link between hyperlipoproteinemia A and the occurrence of repeated cardiovascular events during follow-up', 'timeFrame': 'Month 18', 'description': 'Cumulative events from the following: myocardial infarction, stroke, PAD stage 4, initiation of renal replacement therapy, death, arterial angioplasty at any site, cardiac decompensation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lipoproteinA'], 'conditions': ['CKD', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The blood level of lipoprotein A (Lp(a)) is linked to mutations in gene 6 and is associated with atherothrombotic risk and clinical manifestations such as myocardial infarction, ischemic stroke, and aortic valve calcification and stenosis. Several studies show an increased cardiovascular risk for a level \\>125 nmol/L. Patients with severe chronic kidney disease (CKD) or on hemodialysis are at high cardiovascular risk, and Lp(a) levels would allow for better reclassification of this cardiovascular risk in the general population.\n\nThe study authors wished to the heterogeneity of the Lp(a) level in the population with CKD stages 4 without renal replacement therapy and to identify whether a high Lp(a) level is associated with cardiovascular comorbidity defined by the presence of cardiovascular comorbidity after adjustment for known risk factors such as diabetic status, obesity, smoking, LDLc level and medical treatment for cardiovascular prevention (statins, etc.). Furthermore, they will evaluate whether there is a link between a high level (\\> 125 mmol/l) of Lp(a) at inclusion in the cohort and the occurrence of cardiovascular or renal events (i.e. death of cardiovascular origin or occurrence of MI, stroke, stage 4 peripheral artery disease (PAD) or initiation of renal replacement) over a follow-up period of 18 months which could raise questions about the benefit of a specific treatment which remains to be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage 4 chronic kidney disease without replacement therapy followed as outpatients at Nîmes University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* Patient being followed at the Nîmes University Hospital for stage 4 chronic kidney disease without replacement therapy\n* Patient available for follow-up at 18 months\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Familial hypercholesterolemia\n* Morbid obesity (BMI \\> 40 kg/m2).\n* Persons deprived of their liberty by a judicial or administrative decision, persons receiving psychiatric care, and persons admitted to a health or social care facility for purposes other than research (Article L1121-6 of the French Public Health Code)'}, 'identificationModule': {'nctId': 'NCT07141628', 'acronym': 'LPACKD45', 'briefTitle': 'Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': "Etude de l'hyperlipoprotéinémie A Comme Marqueur de Risque Cardio-vasculaire Chez Les Patients Atteints de Maladie rénale Chronique au Stade 4", 'orgStudyIdInfo': {'id': 'NIMAO/2024-2/OM01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with stage 4 chronic kidney disease without replacement therapy', 'interventionNames': ['Diagnostic Test: lipoprotein A level dosing']}], 'interventions': [{'name': 'lipoprotein A level dosing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Plasma levels measured in mmol/l', 'armGroupLabels': ['Patients with stage 4 chronic kidney disease without replacement therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'Olivier Moranne', 'role': 'CONTACT', 'email': 'olivier.moranne@chu-nimes.fr', 'phone': '04.66.68.32.59'}], 'overallOfficials': [{'name': 'Olivier Moranne', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}