Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-27 @ 2:27 AM
Study NCT ID:
NCT01066559
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who will respond to vaccination', 'timeFrame': 'Week 40'}], 'secondaryOutcomes': [{'measure': 'Percentage and the level of anti-HBs antibodies', 'timeFrame': 'at week 16, week 20, week 24 and week 40'}, {'measure': 'Correlation between the sCD40 levels and the response to HBV vaccination', 'timeFrame': 'At week 12 and week 40'}, {'measure': 'Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.', 'timeFrame': 'at week 12, week 24, and week 36'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Renal Failure', 'Humoral Immune Alterations']}, 'referencesModule': {'references': [{'pmid': '31722332', 'type': 'DERIVED', 'citation': 'de Precigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination', 'detailedDescription': 'Chronic renal failure is associated with humoral immune alterations characterized by a diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular contact between immunological cells have been hypothesized to explain this observation but the precise mechanism leading to this "immunocompromised" status is not clear. The soluble form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154 contact, which is pivotal in the establishment of a proper humoral immune response. It has been shown that the most elevated sCD40 levels are associated with a lack of response to HBV vaccination in the hemodialyzed patients. The majority of the hemodialysis membranes, including high flux polysulfone membranes are unable to clear sCD40 from the sera. However, we found that the high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical Company, Japan) allows for sCD40 clearing.\n\nThe aim of this study is to assess the effect of dialysis on PMMA membrane on the improvement of humoral immune response through the efficiency of HBV vaccination in hemodialysed patients who were non responders to one ore more previous vaccination and its link to sCD40 clearing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 80 years, male or female\n* Patient not immunized against hepatitis B despite complete well done anterior vaccination according to recommendations\n* Hemodialyzed patients with hemodialysed sessions performed three times a week\n* Patient able to give informed consent and affiliated to the medical insurance\n\nExclusion Criteria:\n\n* Pregnant woman\n* Patient never vaccinated against HBV\n* Previous known hepatitis B even without anti HBs antibody (anti HBc antibody or HBs antigenemia positive)\n* Active neoplasia or plasma cell dyscrasia\n* VIH infection\n* Known allergy to vaccine or to PMMA membrane\n* Patient dialysed with PMMA membrane within three months before screening\n* Necessity of acetate free biofiltration or hemodiafiltration as the technique of extrarenal epuration\n* Vascular access problem with necessity of unipuncture for more than 30% of dialysis sessions.\n* Patient under judicial protection'}, 'identificationModule': {'nctId': 'NCT01066559', 'acronym': 'HEPADIAL', 'briefTitle': 'Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Multicentric Randomized Trial of the Impact of Hemodialysis With Polymethylmetacrylate Membrane on the Improvement of Humoral Immune Response in the Hemodialyzed Patients: Application to Hepatitis B Vaccination and Correlation to sCD40 Clearing', 'orgStudyIdInfo': {'id': 'CHUBX 2009/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High flux polymethylmetacrylate membrane', 'interventionNames': ['Procedure: High flux polymethylmetacrylate membrane', 'Biological: Hepatitis B serological control', 'Biological: Seric sCD40 level']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polysulfone membranes', 'interventionNames': ['Procedure: Polysulfone membrane', 'Biological: Hepatitis B serological control', 'Biological: Seric sCD40 level']}], 'interventions': [{'name': 'High flux polymethylmetacrylate membrane', 'type': 'PROCEDURE', 'description': 'Patients will be hemodialysed with high flux polymethylmetacrylate membranes', 'armGroupLabels': ['High flux polymethylmetacrylate membrane']}, {'name': 'Polysulfone membrane', 'type': 'PROCEDURE', 'description': 'Patients be hemodialysed with polysulfone membranes', 'armGroupLabels': ['Polysulfone membranes']}, {'name': 'Hepatitis B serological control', 'type': 'BIOLOGICAL', 'description': 'It will be assessed at week 16, week 20 and week 40', 'armGroupLabels': ['High flux polymethylmetacrylate membrane', 'Polysulfone membranes']}, {'name': 'Seric sCD40 level', 'type': 'BIOLOGICAL', 'description': 'Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.', 'armGroupLabels': ['High flux polymethylmetacrylate membrane', 'Polysulfone membranes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Annonay', 'country': 'France', 'facility': 'CH Annonay', 'geoPoint': {'lat': 45.23992, 'lon': 4.6707}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'CH de la côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Saint-Augustin Clinic, Dialyze Unit', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Pellegrin Hospital, Nephrology Unit', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Larrey Hospital, Dialyze Unit', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Valérie de PRECIGOUT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux, France'}, {'name': 'Pierre BORIES, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse, France'}, {'name': 'Michel RINCE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Limoges, France'}, {'name': 'Caroline DELCLAUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital, Libourne, France'}, {'name': 'Antoine POMMEREAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic Saint-Augustin, Bordeaux, France'}, {'name': 'Benjamin DEROURE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic Delay, Bayonne, France'}, {'name': 'Hervé BONAREK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital, Saintes, France'}, {'name': 'Antoine BENARD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Bordeaux, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}