Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05362812
Status:
UNKNOWN
Last Update Posted:
2022-05-10
First Post:
2022-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Lupus Renal Flares Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'urine, lymphocytes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2022-05-02', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal flares within the next 6 months', 'timeFrame': '6 months', 'description': 'To evaluate whether the number of urinary CD4+ T cells has the potential to predict subsequent renal flares in the next 6 months.\n\nRenal flares will be defined as an increase of proteinuria by \\> 0.5 g/g creatinine or an increase in creatinine by 30% without other likely explanation or a novel kidney biopsy demonstrating lupus nephritis.'}], 'secondaryOutcomes': [{'measure': 'To investigate whether the phenotype of urinary T cell subsets can predict renal involvement or subsequent renal flares in preexisting LN (CD4+ and CD8+ T cells subsets).', 'timeFrame': '6 months'}, {'measure': 'To investigate whether the number and phenotype of urinary B- and plasma cell subsets can predict renal involvement or subsequent renal flares in preexisting LN', 'timeFrame': '6 months'}, {'measure': 'To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement.', 'timeFrame': '6 months'}, {'measure': 'To assess whether urinary or peripheral blood T- and B cell subsets or IFN-I activity can predict the incidence of mild/moderate or severe flares of SLE according to the SELENA-SLEDAI Flare Index (SFI)', 'timeFrame': '6 months'}, {'measure': 'Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function.', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Lupus Nephritis', 'Flow Cytometry', 'CD4-Positive T-Lymphocytes', 'Biomarker', 'Urine Specimen Collection'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '23475982', 'type': 'BACKGROUND', 'citation': 'Enghard P, Rieder C, Kopetschke K, Klocke JR, Undeutsch R, Biesen R, Dragun D, Gollasch M, Schneider U, Aupperle K, Humrich JY, Hiepe F, Backhaus M, Radbruch AH, Burmester GR, Riemekasten G. Urinary CD4 T cells identify SLE patients with proliferative lupus nephritis and can be used to monitor treatment response. Ann Rheum Dis. 2014 Jan;73(1):277-83. doi: 10.1136/annrheumdis-2012-202784. Epub 2013 Mar 8.'}, {'pmid': '28859328', 'type': 'BACKGROUND', 'citation': 'Rose T, Grutzkau A, Klotsche J, Enghard P, Flechsig A, Keller J, Riemekasten G, Radbruch A, Burmester GR, Dorner T, Hiepe F, Biesen R. Are interferon-related biomarkers advantageous for monitoring disease activity in systemic lupus erythematosus? A longitudinal benchmark study. Rheumatology (Oxford). 2017 Sep 1;56(9):1618-1626. doi: 10.1093/rheumatology/kex220.'}, {'pmid': '33670902', 'type': 'BACKGROUND', 'citation': 'Burns M, Ostendorf L, Biesen R, Grutzkau A, Hiepe F, Mei HE, Alexander T. Dysregulated CD38 Expression on Peripheral Blood Immune Cell Subsets in SLE. Int J Mol Sci. 2021 Feb 28;22(5):2424. doi: 10.3390/ijms22052424.'}]}, 'descriptionModule': {'briefSummary': 'In patients with systemic lupus erythematosus, urinary CD4+ T cells may have the potential to predict subsequent renal flares in the next 6 months. Patients with systemic lupus erythematosus from our outpatient clinic will be included in this cross-sectional, prospective biomarker study regardless of disease activity, clinical phenotype, and disease duration or baseline therapy. Urinary T cells will be analyzed by flow cytometry. 6 months after sample collection a clinical follow-up will be conducted to assess the occurrence of either recurrent or de novo renal flares.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with systemic lupus erythematosus from the outpatient clinic of the Department of Rheumatology and Clinical Immunology, University Hospital Charité, Berlin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria Stable immunosuppressive or biologic background therapy within the last 6 months prior to inclusion\n\nExclusion Criteria:\n\n* Age \\< 18\n* Inability to consent\n* Urinary tract infection (defined by detection of nitrite or positive urine culture)\n* Patients on chronic dialysis\n* Concomitant other autoimmune disease'}, 'identificationModule': {'nctId': 'NCT05362812', 'briefTitle': 'Prediction of Lupus Renal Flares Study', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prediction of Lupus Renal Flares Study', 'orgStudyIdInfo': {'id': 'PreLuFlare'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with systemic lupus erythematosus', 'description': 'Diagnostic Test: Flow cytometry analysis of urine samples. Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and B cell panel with fluorochromes. T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD38, CD279; B cell panel: CD19, CD20, CD27, CD38, CD21, IgD, CXCR5'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Enghard, PD Dr. med.', 'role': 'CONTACT', 'email': 'philipp.enghard@charite.de', 'phone': '030 450 614016'}], 'facility': 'Department of Nephrology and Intensive Care, Charite University Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Philipp Enghard, PD Dr. med.', 'role': 'CONTACT', 'email': 'philipp.enghard@charite.de', 'phone': '030 450 614016'}, {'name': 'Johanna S Kotzbauer', 'role': 'CONTACT', 'email': 'johanna.kotzbauer@charite.de'}], 'overallOfficials': [{'name': 'Philipp Enghard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology and Intensive Care, Charite University Hospital'}, {'name': 'Tobias Alexander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rheumatology and Clinical Immunology, Charite University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med', 'investigatorFullName': 'Philipp Enghard', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}