Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT06710834
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Hemodiafiltration with and Without Hemoadsorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017583', 'term': 'Hemodiafiltration'}], 'ancestors': [{'id': 'D006435', 'term': 'Renal Dialysis'}, {'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D006440', 'term': 'Hemofiltration'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uremic toxins reduction ratios (RR)', 'timeFrame': 'From enrollment to the end of treatment at 4-8 weeks.', 'description': 'Protein bound uremic toxins: p-cresyl sulfate RR, and indoxyl-sulfate RR. Medium and large molecules: ß2-microglobulin (11,800 Da) RR, myoglobin (17,200 Da) RR, kappa FLC (22,500 Da) RR, prolactin (23,000 Da) RR, α1-microglobulin (33,000 Da) RR, α1-acid glycoprotein (41,000 Da) RR, and lambda FLC (45,000 Da) RR.'}], 'secondaryOutcomes': [{'measure': 'Uremic toxins reduction ratios', 'timeFrame': 'From enrollment to the end of treatment at 4-8 weeks', 'description': 'Urea RR (60 Da), creatinine RR (113 Da), and albumin (66,000 Da)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adsorption', 'Convection', 'Hemodiafiltration', 'Efficacy'], 'conditions': ['Hemodialysis', 'Hemodiafiltration', 'Hemoadsorption']}, 'descriptionModule': {'briefSummary': 'Goals: The aim of the study is to assess the efficacy and safety of the combination of HDF + HA compared to HDF. To do this, we will evaluate the elimination of a wide range of molecular weight molecules, including small protein-bound solutes.\n\nDesign: Prospective, single-center study. Each patient underwent two dialysis sessions with routine dialysis parameters in which HDF or HDF + HA treatment modality will be compared.\n\nStudy subjects: 20 patients, stable on a thrice-weekly hemodialysis program, will be included. Local Ethics Committee will approve the study and patients will give informed consent.\n\nInterventions: Prospective collection of two dialysis sessions. The only difference among the sessions in each patient will be add or no sorbent cartridge. One session with FX60 Cordiax, helixone, Fresenius Medical Care in postdilution on-line hemodiafiltration and another session with the same dialyzer plus HA 130 cartridge. The order of these treatment sessions was randomly. Blood samples for analyses were taken for each patient in the same dialysis session of the week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Adult patients (age \\> 18 years)\n* More than 6 months on a dialysis program\n* Stable in a hemodialysis program\n* AV fistula, prosthesis, or tunneled catheter as vascular access\n* No residual diuresis (\\< 200 ml/day)\n* Not enrolled in a living donor transplant program\n* No immunosuppressive treatment\n* Provide written informed consent\n\nExclusion Criteria\n\n* Chronic inflammatory diseases\n* Neoplasms\n* Immunosuppressive treatment or chronic treatment with anti-inflammatory drugs\n* Dysfunctional AV fistula or catheter\n* Single-needle dialysis\n* Kt/V less than 1.3 or PRU \\< 70%\n* Scheduled living donor kidney transplant'}, 'identificationModule': {'nctId': 'NCT06710834', 'briefTitle': 'Comparing Hemodiafiltration with and Without Hemoadsorption', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Evaluating the Effectiveness of Combining Hemodiafiltration and Hemoadsorption in Comparison to Hemodiafiltration Alone', 'orgStudyIdInfo': {'id': 'HCB/2024/0704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hemodiafiltration alone', 'interventionNames': ['Device: Hemodiafiltration']}, {'type': 'EXPERIMENTAL', 'label': 'Hemodiafiltration plus hemoadsorption', 'interventionNames': ['Device: Hemoadsorption cartridge', 'Device: Hemodiafiltration']}], 'interventions': [{'name': 'Hemoadsorption cartridge', 'type': 'DEVICE', 'description': 'HA 130 cartridge', 'armGroupLabels': ['Hemodiafiltration plus hemoadsorption']}, {'name': 'Hemodiafiltration', 'type': 'DEVICE', 'description': 'Postdilutional hemodiafiltration', 'armGroupLabels': ['Hemodiafiltration alone', 'Hemodiafiltration plus hemoadsorption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Dialysis Section', 'investigatorFullName': 'Francisco Maduell', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}