Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-04 @ 5:49 PM
Study NCT ID:
NCT06631404
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-14', 'releaseDate': '2025-07-29'}], 'estimatedResultsFirstSubmitDate': '2025-07-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'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'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'doppler for renal artery', 'timeFrame': '1 year', 'description': 'resistive index of renal artery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'referencesModule': {'references': [{'pmid': '35932197', 'type': 'BACKGROUND', 'citation': 'Alforaih N, Whittall-Garcia L, Touma Z. A Review of Lupus Nephritis. J Appl Lab Med. 2022 Oct 29;7(6):1450-1467. doi: 10.1093/jalm/jfac036.'}, {'pmid': '36407159', 'type': 'BACKGROUND', 'citation': 'Ameer MA, Chaudhry H, Mushtaq J, Khan OS, Babar M, Hashim T, Zeb S, Tariq MA, Patlolla SR, Ali J, Hashim SN, Hashim S. An Overview of Systemic Lupus Erythematosus (SLE) Pathogenesis, Classification, and Management. Cureus. 2022 Oct 15;14(10):e30330. doi: 10.7759/cureus.30330. eCollection 2022 Oct.'}, {'pmid': '31974366', 'type': 'BACKGROUND', 'citation': 'Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9.'}, {'pmid': '35589256', 'type': 'BACKGROUND', 'citation': 'Anstee QM, Castera L, Loomba R. Impact of non-invasive biomarkers on hepatology practice: Past, present and future. J Hepatol. 2022 Jun;76(6):1362-1378. doi: 10.1016/j.jhep.2022.03.026.'}]}, 'descriptionModule': {'briefSummary': 'Systemic Lupus Erthymatosous (SLE) is achronic inflammatory multi system auto immue disease characterized by pathogenic auto anti bodies production against nuclear structures (Bolouri et al.,2022), SLE affecting mainly woemn of childbearing age and is chracterized by unpredictable flares and remissions , disease variety varied from mild episode disorder to arpidly progressive life -threatening illness..\n\nLN is diagnosed by either the presence of proteinuria \\>0.5g/day. active urinary sediment , or an unexplained rise in serum creatinine there fore , identifying new invasive biomarkers of LN severity and outcome is mandatory, Renal Arterial resistive index ( RRI) is anon invasive biomarker that has been studied as apotential indicator of disease activity in LN patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Aged ≥18 years.\n\n* SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls.\n* Patients cooperative and can answer questions.\n* Patients who are able and willing to give written informed consent.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years.\n* SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls.\n* Patients cooperative and can answer questions.\n* Patients who are able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* • Individuals with other autoimmune diseases.\n\n * Diabetes.\n * Hypertension.\n * Heart failure.\n * Hepatic diseases.\n * Chronic renal failure.\n * Renal artery stenosis.\n * Renal vein thrombosis.\n * Intrarenal arteriovenous fistula.\n * Obstructive nephropathy.\n * Urinary tract obstruction that could affect RI of intra renal arteries.\n * Un cooperative patients.\n * Patients not able and willing to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT06631404', 'briefTitle': 'Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-24-09-07MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group SLE', 'description': 'Patients with SLE', 'interventionNames': ['Diagnostic Test: renal doppler']}, {'label': 'group control', 'description': 'matched healthy subjects', 'interventionNames': ['Diagnostic Test: renal doppler']}], 'interventions': [{'name': 'renal doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'doppler srudy on renal arteries bilaterally , and detection of RI of renal artery', 'armGroupLabels': ['group SLE', 'group control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Sohag', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Doaa R Abdelkarim, resident', 'role': 'CONTACT', 'email': 'doaa_rabea_post@med.sohag.edu.eg', 'phone': '01027673294'}, {'name': 'Esam M Abualfadl, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at rheumatology and rehabilitation department', 'investigatorFullName': 'Doaa Rabea Abdelkarim', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-29', 'type': 'RELEASE'}, {'date': '2025-08-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Doaa Rabea Abdelkarim, resident at rheumatology and rehabilitation department, Sohag University'}}}}