Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:25 PM
Study NCT ID:
NCT04747067
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'It is a pilot crossover study, 25 ESRD patients were dialyzed using dialyzer; BIOPURE 260 HF on a single session on two hemodialysis modalities (conventional HD and online post-dilution HDF) with washout period of 2 weeks using high flux dialyzers with maximum surface area 2.0 m2.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2021-02-06', 'studyFirstSubmitQcDate': '2021-02-06', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free light chain reduction', 'timeFrame': '1 day of hemodialysis session', 'description': 'Measurement of kappa (23KDa) and lambda (45 KDa)free light chains levels, pre and post dialysis session, in patients undergoing high-flux dialysis versus HDF.'}], 'secondaryOutcomes': [{'measure': 'Cumulative albumin loss', 'timeFrame': '1 day of hemodialysis session', 'description': 'Assessment of cumulative dialysate albumin loss by measuring albumin spent in dialysate -hourly- in patients undergoing high flux dialysis versus HDF'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['End stage renal disease (ESRD)', 'hemodiafiltration (HDF)', 'hemodialysis (HD)', 'Free light chains', 'Albumin loss', 'Kappa and lambda'], 'conditions': ['End Stage Renal Disease', 'Hemodiafiltration', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '26022721', 'type': 'BACKGROUND', 'citation': 'Bourguignon C, Chenine L, Bargnoux AS, Leray-Moragues H, Canaud B, Cristol JP, Morena M. Hemodiafiltration improves free light chain removal and normalizes kappa/lambda ratio in hemodialysis patients. J Nephrol. 2016 Apr;29(2):251-257. doi: 10.1007/s40620-015-0207-z. Epub 2015 May 29.'}, {'pmid': '27884120', 'type': 'BACKGROUND', 'citation': 'Donati G, Moretti MI, Baraldi O, Spazzoli A, Capelli I, Comai G, Marchetti A, Sarma M, Mancini R, La Manna G. Removal of free light chains in hemodialysis patients without multiple myeloma: a crossover comparison of three different dialyzers. BMC Nephrol. 2016 Nov 25;17(1):193. doi: 10.1186/s12882-016-0405-5.'}, {'pmid': '24603634', 'type': 'BACKGROUND', 'citation': 'Lamy T, Henri P, Lobbedez T, Comby E, Ryckelynck JP, Ficheux M. Comparison between on-line high-efficiency hemodiafiltration and conventional high-flux hemodialysis for polyclonal free light chain removal. Blood Purif. 2014;37(2):93-8. doi: 10.1159/000357968. Epub 2014 Mar 1.'}, {'pmid': '29813181', 'type': 'BACKGROUND', 'citation': 'Maduell F. Hemodiafiltration versus conventional hemodialysis: Should "conventional" be redefined? Semin Dial. 2018 Nov;31(6):625-632. doi: 10.1111/sdi.12715. Epub 2018 May 29.'}, {'pmid': '28452109', 'type': 'BACKGROUND', 'citation': 'Nagai K, Tsuchida K, Ishihara N, Minagawa N, Ichien G, Yamada S, Hirose D, Michiwaki H, Kanayama HO, Doi T, Minakuchi J. Implications of Albumin Leakage for Survival in Maintenance Hemodialysis Patients: A 7-year Observational Study. Ther Apher Dial. 2017 Aug;21(4):378-386. doi: 10.1111/1744-9987.12526. Epub 2017 Apr 27.'}, {'pmid': '29106652', 'type': 'BACKGROUND', 'citation': 'van Gelder MK, Abrahams AC, Joles JA, Kaysen GA, Gerritsen KGF. Albumin handling in different hemodialysis modalities. Nephrol Dial Transplant. 2018 Jun 1;33(6):906-913. doi: 10.1093/ndt/gfx191.'}, {'pmid': '29507008', 'type': 'BACKGROUND', 'citation': 'Wolley M, Jardine M, Hutchison CA. Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules. Clin J Am Soc Nephrol. 2018 May 7;13(5):805-814. doi: 10.2215/CJN.10110917. Epub 2018 Mar 5.'}, {'pmid': '30281131', 'type': 'BACKGROUND', 'citation': 'Wolley MJ, Hutchison CA. Large uremic toxins: an unsolved problem in end-stage kidney disease. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii6-iii11. doi: 10.1093/ndt/gfy179.'}]}, 'descriptionModule': {'briefSummary': 'Removal of uremic toxins is the main goal of HD, It was improved by using high volume convective technique with high flux (HF) dialyzer. This technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life.\n\nThis study will assess the effect of hemodiafiltration (HDF) versus high flux dialysis on free light chains (FLC) reduction as a marker of HD adequacy and its relation to albumin loss using dialyzer effective surface area 2.6m2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prevalent HD patients on regular hemodialysis sessions for \\>6 months 3 sessions/week of 4 hours duration.\n* Patients with Arterio-venous fistula as dialysis access.\n\nExclusion Criteria:\n\n* Patients with hemodialysis catheters.\n* Patients with active inflammation or infection.\n* Decompensated heart failure.\n* Liver Cell Failure ( Child B,C)\n* Patients with known malignancies.'}, 'identificationModule': {'nctId': 'NCT04747067', 'briefTitle': 'To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Hemodiafiltration Versus High Flux Dialysis On Free Light Chains Reduction And Its Relation To Albumin Loss.', 'orgStudyIdInfo': {'id': 'HD vs HDF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-flux Hemodialysis', 'description': 'patients treated by conventional hemodialysis', 'interventionNames': ['Device: BIOPURE 260HF dialyzer']}, {'type': 'EXPERIMENTAL', 'label': 'Hemodiafiltration', 'description': 'patients treated by online post-dilution hemodialysis', 'interventionNames': ['Device: BIOPURE 260HF dialyzer']}], 'interventions': [{'name': 'BIOPURE 260HF dialyzer', 'type': 'DEVICE', 'description': 'Dialyzer with effective surface area 2.6 m2, High-flux polyethersulfone hollow fiber with steam sterilization, myoglobin sieving coefficient (SC) 0.7, membrane cutoff 40,000 Daltons (Allmed Medical Gmbh)', 'armGroupLabels': ['Hemodiafiltration', 'High-flux Hemodialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Cairo', 'state': 'Governorate', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Reem Sultan, M.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Ain Shams Univeristy.'}, {'name': 'Hesham ElSayed, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, Ain Shams Univeristy'}, {'name': 'Magdy ElSharkawy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, Ain Shams Univeristy'}, {'name': 'Waleed AbdelMohsen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Ain Shams Univeristy'}, {'name': 'Shaimaa Zaki, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Ain Shams Univeristy'}, {'name': 'Ahmed Emara, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Ain Shams Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Internal Medicine and Nephrology', 'investigatorFullName': 'Reem Sultan', 'investigatorAffiliation': 'Ain Shams University'}}}}