Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-30 @ 3:59 PM
Study NCT ID:
NCT03184103
Status:
UNKNOWN
Last Update Posted:
2017-06-14
First Post:
2017-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Post Streptococcal Glomerulonephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-12-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with full recovery or having complication at time of discharge and after 8 week', 'timeFrame': 'one year', 'description': 'serum complementary test by ELISA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PSGN - Post-Streptococcal Glomerulonephritis']}, 'referencesModule': {'references': [{'pmid': '10232333', 'type': 'BACKGROUND', 'citation': 'Couser WG. Glomerulonephritis. Lancet. 1999 May 1;353(9163):1509-15. doi: 10.1016/S0140-6736(98)06195-9.'}, {'pmid': '27099135', 'type': 'BACKGROUND', 'citation': 'Arimura Y, Muso E, Fujimoto S, Hasegawa M, Kaname S, Usui J, Ihara T, Kobayashi M, Itabashi M, Kitagawa K, Hirahashi J, Kimura K, Matsuo S. Evidence-based clinical practice guidelines for rapidly progressive glomerulonephritis 2014. Clin Exp Nephrol. 2016 Jun;20(3):322-41. doi: 10.1007/s10157-015-1218-8. No abstract available.'}, {'pmid': '9090652', 'type': 'RESULT', 'citation': 'Arora P, Kher V, Rai PK, Singhal MK, Gulati S, Gupta A. Prognosis of acute renal failure in children: a multivariate analysis. Pediatr Nephrol. 1997 Apr;11(2):153-5. doi: 10.1007/s004670050247.'}, {'pmid': '12746805', 'type': 'RESULT', 'citation': 'Barbiano Di Belgiojoso G, Genderini A, Ferrario F. [Post-infectious glomerulonephritis]. G Ital Nefrol. 2003 Mar-Apr;20(2):184-99. Italian.'}, {'pmid': '12572934', 'type': 'RESULT', 'citation': 'Matsukura H, Ohtsuki A, Fuchizawa T, Miyawaki T. Acute poststreptococcal glomerulonephritis mimicking Henoch-Schonlein purpura. Clin Nephrol. 2003 Jan;59(1):64-5. doi: 10.5414/cnp59064. No abstract available.'}, {'pmid': '17331245', 'type': 'RESULT', 'citation': 'Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.'}, {'pmid': '10680980', 'type': 'RESULT', 'citation': 'Nordstrand A, Norgren M, Holm SE. Pathogenic mechanism of acute post-streptococcal glomerulonephritis. Scand J Infect Dis. 1999;31(6):523-37. doi: 10.1080/00365549950164382.'}, {'pmid': '19384327', 'type': 'RESULT', 'citation': 'Kanjanabuch T, Kittikowit W, Eiam-Ong S. An update on acute postinfectious glomerulonephritis worldwide. Nat Rev Nephrol. 2009 May;5(5):259-69. doi: 10.1038/nrneph.2009.44.'}]}, 'descriptionModule': {'briefSummary': 'Acute post streptococcal glomerulonephritis is an immunologic response of the kidney to infection, characterized by the sudden appearance of edema, hematuria, proteinuria and hypertension . It is essentially a disease of childhood that accounts for approximately 90% of renal disorders in children. The disease occurs especially in children between the ages of 2 and 12 years and young adults, and more often in male than in female .', 'detailedDescription': "Acute post streptococcal glomerulonephritis are caused by group A beta haemolytic streptococci and follow upper airway infections such as pharyngitis or tonsillitis, by 14 to 21 days and 3-6 weeks after skin infection especially in warmer climates .\n\nIn recent decades the number of patients with post streptococcal glomerulonephritis has decreased considerably in the United States and Europe industrialized countries. In other parts of the world ,some developing communities. the incidence of post streptococcal glomerulonephritis has remained high. post streptococcal glomerulonephritis is one of the leading cause requiring hospital admissions in children , and it is also an important cause of acute renal failure in developing countries. Though deaths due to this disease are rare, it can cause serious complications such as hypertensive emergency, congestive cardiac failure, renal failure, encephalopathy and retinopathy .\n\nAcute post streptococcal glomerulonephritis can also progress to rapidly progressive glomerulonephritis which is defined as''a syndrome that progresses rapidly within a few weeks or months to renal failure and is accompanied by urinary findings of nephritis.'' The clinical concept of rapidly progressive glomerulonephritis includes various renal diseases that cause renal function to deteriorate over a subacute course. Necrotizing crescentic glomerulonephritis is often observed in histopathological findings .\n\nAcute post streptococcal glomerulonephritis was diagnosed in the presence of :\n\nfeatures of acute nephritic syndrome. evidence of recent streptococcal infection. lower serum complement three levels. Anti streptolysin o titre \\>200 units/ml was considered as evidence of recent streptococcal infection"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be done on children attending at Assiut University Children Hospital with clinical manifestation of acute post streptococcal glomerulonephritis during one year period .\n\nIn addition to meticulous history taking and thorough clinical examination , all the cases will be subjected to the following laboratory investigations :\n\nComplete blood count on admission, urine analysis, blood urea, serum creatinine, serum albumin, serum cholesterol, urine spot protein creatinine ratio, antistreptolysin O , Erythrocyte sedimentation rate , C-reactive protein and serum complement C3 levels on admission and after 8 weeks.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children in the age groups of 2-15 years. presenting with clinical manifestation of acute nephritic syndrome will be included in the study.\n\nExclusion Criteria:\n\n* Children having history suggestive of chronic renal and cardiac disease in the past\n* Children with congenital renal anomalies .\n* Children with clinical manifestation of nephrotic syndrome .\n* Children with clinical manifestation of acute nephritic syndrome due to other causes .'}, 'identificationModule': {'nctId': 'NCT03184103', 'briefTitle': 'Acute Post Streptococcal Glomerulonephritis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Spectrum and Outcome of Acute Post Streptococcal Glomerulonephritis in Children .', 'orgStudyIdInfo': {'id': 'APSGN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'anti streptolysin o titre and serum complement test', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnostic lab test'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa Shafeek, MD', 'role': 'CONTACT', 'email': 'Drmostafashafeek20@gmail.com', 'phone': '01112110096'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'MSHEid', 'investigatorAffiliation': 'Assiut University'}}}}