Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT02981992
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2016-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T Regulatory Cells in Hemodialysis Patients: Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sample used to evaluate T cell subpopulations'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2016-11-26', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treg number', 'timeFrame': 'Assessment of Treg number at basal control and then every 3 months for a total study period of 12 months', 'description': 'Assessment of the number of Treg by flow cytometry.'}], 'secondaryOutcomes': [{'measure': 'Treg function', 'timeFrame': 'Assessment of Treg function at basal control and then every 3 months for a total study period of 12 months', 'description': 'Evaluation of Treg function by measuring the ability to inhibit cell proliferation in the context of a mixed lymphocyte reaction.'}, {'measure': 'Effect of dialysis modality', 'timeFrame': 'Analysis of the number and function of Treg cells in function of the type of dialysis treatment at basal control and then every 6 months for a total study period of 12 months', 'description': 'Evaluation of the number and function of Treg cells before and after dialysis (by flow cytometry and in vitro experiments), as a function of the type of dialysis treatment by use of multivariate regression models'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Haemodialysis Complication', 'Immune Dysfunction']}, 'referencesModule': {'references': [{'pmid': '19193737', 'type': 'BACKGROUND', 'citation': 'Hendrikx TK, van Gurp EA, Mol WM, Schoordijk W, Sewgobind VD, Ijzermans JN, Weimar W, Baan CC. End-stage renal failure and regulatory activities of CD4+CD25bright+FoxP3+ T-cells. Nephrol Dial Transplant. 2009 Jun;24(6):1969-78. doi: 10.1093/ndt/gfp005. Epub 2009 Feb 4.'}, {'pmid': '20164820', 'type': 'BACKGROUND', 'citation': 'Sewgobind VD, van der Laan LJ, Kho MM, Kraaijeveld R, Korevaar SS, van Dam T, Ijzermans JN, Weimar W, Baan CC. Characterization of rabbit antithymocyte globulins-induced CD25+ regulatory T cells from cells of patients with end-stage renal disease. Transplantation. 2010 Mar 27;89(6):655-66. doi: 10.1097/TP.0b013e3181c9cc7a.'}, {'pmid': '25851286', 'type': 'BACKGROUND', 'citation': 'Sharif MR, Chitsazian Z, Moosavian M, Raygan F, Nikoueinejad H, Sharif AR, Einollahi B. Immune disorders in hemodialysis patients. Iran J Kidney Dis. 2015 Mar;9(2):84-96.'}, {'pmid': '21865772', 'type': 'BACKGROUND', 'citation': 'Uda S, Mizobuchi M, Akizawa T. Biocompatible characteristics of high-performance membranes. Contrib Nephrol. 2011;173:23-29. doi: 10.1159/000328941. Epub 2011 Aug 8.'}, {'pmid': '20157169', 'type': 'RESULT', 'citation': 'Libetta C, Esposito P, Sepe V, Portalupi V, Margiotta E, Canevari M, Dal Canton A. Dialysis treatment and regulatory T cells. Nephrol Dial Transplant. 2010 May;25(5):1723-7. doi: 10.1093/ndt/gfq055. Epub 2010 Feb 15. No abstract available.'}, {'pmid': '31729973', 'type': 'DERIVED', 'citation': 'Sepe V, Gregorini M, Rampino T, Esposito P, Coppo R, Galli F, Libetta C. Vitamin e-loaded membrane dialyzers reduce hemodialysis inflammaging. BMC Nephrol. 2019 Nov 15;20(1):412. doi: 10.1186/s12882-019-1585-6.'}]}, 'descriptionModule': {'briefSummary': 'In this observational study, the investigators evaluated the Treg number and function in a population of patients undergoing hemodialysis (HD).\n\nIn particular, the investigators considered the relationship of Treg cell status with the different HD modalities and clinical parameters.', 'detailedDescription': "Patients on hemodialysis (HD) present an elevated risk of cardiovascular disease, cancer and infectious events that may lead to the high morbidity and mortality rate characteristic of this population. Many causes can explain this increased risk, including inflammation that, in turn, might be secondary to dialysis-specific factors, such as contaminated water, dialysis modality and dialysis membranes used for treatment.\n\nIn addition to chronic inflammatory, in HD patients is also present a significant alteration of the immune system resulting in chronic lymphocytic infiltration, alteration of T-helper balance (Th1/Th2) etc. The immune response is controlled by very complex mechanisms; it is mediated by interaction between antigen-presenting cells (APC), CD4+ T helper (Th) and T cells CD4+ CD25+ regulatory (Treg), a cell subpopulation of T CD4+ expressing the IL-2 receptor (CD25) and forkhead factor (foxp 3). Treg cells contribute to the maintenance of peripheral tolerance by suppressing the immune response to self-normal or tumor antigens. Treg cells control population's expansion of peripheral cells and suppress the proliferation of Th activated cells. Accessory molecules such as CTLA-4 receptors, CD28 and IL-2 cytokines and IL-6, contribute to the activation and proliferation of Treg cells.\n\nThe characterization by flow cytometry of Treg suffered for a lack of specific surface markers. These cells are generally identified on the basis of contemporary expression of molecules CD4 and CD25, but the specificity of these markers is limited, given that the CD25 is also expressed on activated lymphocytes. Recently it has been showed that the expression of Foxp3 gene is a phenomenon strictly linked to the development of regulatory activity of Treg, and so, the extent of the expression of this gene by Real Time PCR is currently considered the most specific Treg marker. There is very poor data on Treg cells function in HD. A recent study shows that in patients on chronic HD, the number of Treg is lower if compared to healthy subjects. Moreover, the Treg cells of patients on HD would present a significant impairment of their function, assessed as the ability to inhibit lymphocyte proliferation.\n\nThose results, however, are affected by the lack of data on the characteristics of the studied patients and the type of dialysis treatment applied. In contrast, a recent study by our group showed that patients on hemodialysis with poor biocompatible membranes have a greater number of circulating Treg compared with healthy controls matched for age and sex.\n\nGiven the absence of other data, it still remains to investigate the actual significance and function of Treg in HD, considering that Treg status might potentially affect the immune response.\n\nTherefore, the purpose of this study was to evaluate the structure and function of Treg cells in patients undergoing HD, also considering their relationship with the different HD modalities and clinical parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total number of 30 prevalent patients undergoing chronic renal replacement terapy with hemodialysis (HD) has been included in the evaluation. The study duration was 12 months, with a check of the number and function of Treg every 3 months.\n\nDuring the study patients were subjected to dialysis and farmacology treatment as usual, without any alteration linked specifically to this protocol. The number and function of Treg were measured as a percentage of CD4+CD25bright+pre-dialysis in the last week of each third month of the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with spKt/V ≥ 1,2\n\nExclusion Criteria:\n\n* Cancer\n* Pregnant or breastfeeding\n* Sepsis\n* Kidney or other organ transplant\n* Major cardiovascular events in the previous 3 months\n* Patients unable to understand or interdicted'}, 'identificationModule': {'nctId': 'NCT02981992', 'briefTitle': 'T Regulatory Cells in Hemodialysis Patients: Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Observational Study on T Regulatory Cells in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '20100014090'}}, 'contactsLocationsModule': {'locations': [{'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione Policlinico "San Matteo"', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Carmelo Libetta, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico "San Matteo", Pavia- Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Carmelo Libetta', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}