Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT07265635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a monocentric, randomized, controlled, crossover trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the filters in term of the reduction of plasma HMWs and PBL death levels in a cross-over design', 'timeFrame': 'up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Identification of plasma proteins composition of the uremic retentates.', 'timeFrame': 'day 0, day 90, day 180'}, {'measure': 'Pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes.', 'timeFrame': 'day 0, day 90, day 180', 'description': 'Thiol metabolomics and pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes'}, {'measure': 'Proteomics studies of the role of GSTP hyperexpression in the modulation of Nrf2 expression and activity in uremic leukocytes.', 'timeFrame': 'day 0, day 90, day 180'}, {'measure': 'Study on transcription factors alternative to Nrf2', 'timeFrame': 'day 0, day 90, day 180', 'description': 'Study on transcription factors alternative to Nrf2 using human and murine Nrf2 inhibited monocyte lines'}, {'measure': 'Study of Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes', 'timeFrame': 'day 0, day 90, day 180', 'description': 'Study of expression and activity of the Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes exposed to isolated uremic retention solutes.'}, {'measure': 'Study of cell death in PBL freshly isolated from study groups', 'timeFrame': 'day 0, day 90, day 180', 'description': 'Study of cell death in PBL freshly isolated from study groups before and after treatment with autologous and heterologous whole plasma or isolated HMW fractions (studies of the IPR mechanism)'}, {'measure': 'Analysis of CD4+ cells from blood samples and assessment of inflammatory cytokines after LPS stimulation', 'timeFrame': 'day 0, day 90, day 180', 'description': 'Purification and culture of CD4+ cells from blood samples and assessment of inflammatory cytokines (IL-4, IL-10, IL-12 p70, IL-18, and IFNγ) after LPS stimulation'}, {'measure': 'Determination of lymphocyte subpopulations ex vivo', 'timeFrame': 'day 0, day 90, day 180'}, {'measure': 'Pathway analysis of the differentially expressed proteins of PBL and of principal component of complement system', 'timeFrame': 'day 0, day 90, day 180'}, {'measure': 'Analysis of HMWs characteristic oxidative PTMs in plasma and PBL lysate samples collected', 'timeFrame': 'day 0, day 90, day 180'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled crossover trial (58) in order to characterize PBL damage and death rate in hemodialysis patients treated with membranes with different permeability, including protein-leaking dialysers.\n\nThe study will enroll fourty patients on regular 4-h three times per week hemodialysis (HD) of the dialysis unit of the "Fondazione IRCCS Policlinico San Matteo" (Pavia, Italy). Thirteen age and sex matched healthy individuals (Ctr) and ten CKD patients on peritoneal dialysis treatment (PD\\*) will be included as healthy and CKD-matched controls, respectively. Comparison between HD and PD patients is aimed to assess the effect of biocompatibility and protein leakage during the treatments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent as documented by signature (Appendix Informed Consent Form)\n* Male or female adults at time of enrolment aged \\<90 years old and \\>18 years old\n* Patients in stable standard bicarbonate HD regimen, for at least two months\n\nExclusion Criteria:\n\n* Patients aged \\<18 years old and \\>90 years old\n* Known hypersensitivity or allergy to class of drugs or the investigational product or inability to comply with the requirements of the protocol;\n* Participation in another study with investigational drug within the 30 days preceding and during the present study;\n* Enrolment of the investigator, his/her family members, employees and other dependent persons;\n* Recent illness (within the previous 1 week);\n* Severe anemia (Hb \\< 7 g/dl);\n* Bacterial or viral active infections;'}, 'identificationModule': {'nctId': 'NCT07265635', 'briefTitle': 'Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response', 'orgStudyIdInfo': {'id': 'PROTEURS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes', 'interventionNames': ['Device: HDF with PMMA', 'Device: HDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF)', 'interventionNames': ['Device: HDF with PMMA', 'Device: HDF']}, {'type': 'NO_INTERVENTION', 'label': 'healthy individuals'}], 'interventions': [{'name': 'HDF with PMMA', 'type': 'DEVICE', 'description': 'Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane', 'armGroupLabels': ['patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes', 'patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF)']}, {'name': 'HDF', 'type': 'DEVICE', 'description': 'Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane', 'armGroupLabels': ['patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes', 'patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Carmelo Libetta', 'investigatorFullName': 'Carmelo Libetta', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}