Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-03-02 @ 4:37 PM
Study NCT ID:
NCT05117450
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2021-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 302}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of hemodialysis session success without heparin', 'timeFrame': '4 weeks', 'description': 'The success of the hemodialysis session is defined by a dialysis time\\> 95% of the prescribed time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.\n\nTo avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.\n\nIn this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.\n\nThe HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session', 'detailedDescription': 'The aim of this study is to compare the HYDROLINK™ membrane to the HeprAN™ membrane in a large-scale trial with the strategy of minimizing the dose of peridialytic heparin in order to reduce the risk of bleeding in chronic hemodialysis patients.\n\nParticipation in the research will be offered at the time of a hemodialysis session to any eligible patient, i.e., over 18 years of age, who has been on chronic hemodialysis for at least 3 months at a rate of three times a week and who has given their consent to this study. A cross over trial will be performed. Each included patient will have hemodialysis sessions with HYDROLINK™ and HeprAN™ membrane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria :\n\n* Patients with Age \\> 18 years\n* Chronic hemodialysis for at least 3 months\n* Hemodialysis three times a week\n* On per dialytic heparin therapy (UFH or LMWH)\n* Affiliated to the French Social Security\n* Having given their consent for this study\n\nexclusion criteria :\n\n* Patients undergoing Hemodiafiltration (HDF)\n* Pregnant or lactating woman\n* Patient participating in another interventional study\n* Persons deprived of liberty by judicial or administrative decision\n* Adults under legal protection (under guardianship or curators)\n* Persons under a legal protection measure\n* Patients with a history of HIT\n* Patients with acquired or congenital coagulation disorders\n* Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers)\n* Patient on an ACE inhibitor (ACE inhibitor)\n* Patient requiring transfusion during the study period\n* Patient not hemoglobin-stabilized (mean Hb \\< 10g/dL or \\>12 g/dL in the previous month)\n* Patient septic or with significant inflammation (defined as C-reactive protein \\> 25mg/L) at the time of inclusion\n* Patient requiring per-dialytic parenteral nutrition\n* Patient requiring hospitalization or scheduled surgery during the study period\n* Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (\\< 300 mL/min determined during the screening phase = blood flow prescribed by the nephrologist)\n* Patient dialyzing on catheter ("single line" or "double line") or in unipuncture on Arteriovenous fistula on the day of the screening session\n* Net ultrafiltration on the day of the screening session \\> 4000 mL'}, 'identificationModule': {'nctId': 'NCT05117450', 'acronym': 'RESTIT', 'briefTitle': 'Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'PO20179*'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HeprAN first', 'description': 'Each included patient will have hemodialysis sessions with HeprAN membrane and then HYDROLINK', 'interventionNames': ['Device: Decrease per-dialytic heparin therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HYDROLINK first', 'description': 'Each included patient will have hemodialysis sessions with HYDROLINK and then HeprAN membrane', 'interventionNames': ['Device: Decrease per-dialytic heparin therapy']}], 'interventions': [{'name': 'Decrease per-dialytic heparin therapy', 'type': 'DEVICE', 'description': 'Decrease per-dialytic heparin therapy with the HYDROLINK membrane (dialyzer NV-21U, surface 2.1m², Toray industry, Tokyo, Japan) and with the HeprAN membrane (dialyzer Evodial 2.2, surface 2.15 m2, Hospal SAS, Meyzieu, France)', 'armGroupLabels': ['HYDROLINK first', 'HeprAN first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien JOLLY', 'role': 'CONTACT', 'email': 'djolly@chu-reims.fr', 'phone': '326788472', 'phoneExt': '33'}], 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Antoine BRACONNIER', 'role': 'CONTACT', 'email': 'abraconnier@chu-reims.fr', 'phone': '03 26 78 41 40', 'phoneExt': '0033'}, {'name': 'Philippe RIEU', 'role': 'CONTACT', 'email': 'prieu@chu-reims.fr', 'phone': '03 26 78 76 38', 'phoneExt': '0033'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}