Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
Study NCT ID:
NCT06188533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Activin A as Apredictive Marker for Assessement of Acute Kidney Injury Severity in Patient Admitted at Assuit University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary activin A in AKI', 'timeFrame': 'Baseline', 'description': 'To correlate between Activin A level in urine and severity of AKI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Activin A in AKI']}, 'descriptionModule': {'briefSummary': 'Urinary Activin A as amarker for assessement of acute kidney injury severity in patient admitted at Assuit University Hospital', 'detailedDescription': "Acute kidney injury has been ahealth problem all over the world , It's prevelance in developing and developed countries is increasing due to pre renal , renal , post renal causes .\n\nEstimates of AKI prevalence range from \\<1% to 66%. These variations can be explained by not only population differences but also inconsistent use of standardized AKI classification criteria. The aetiology and incidence of AKI also differ between high-income and low-to-middle-income countries.(1)\n\n* It can be presented in different stages according to AKIN classification (stage l (Increase in serum creatinine ≥0.3md/dl (≥26.4μmol/l) or increase to \\>150% to 200% (1.5 fold to 2 fold) from baseline , and urine output (\\<0.5 ml/kg/h for \\>6 h ))\n\n * stage ll (Increase to \\>200% to 300% (\\>2 fold to 3 fold) from baseline) , and urine output (\\<0.5 ml/kg/h for \\>12 h ))\n * stage lll(Increase in serum creatinine to \\>300% (\\>3 fold) from baseline, or serum creatinine \\>4.0mg/dl (\\>354μmol/l) with acute increase of atleast 0.5mg/dl ) Urine output(\\<0.3ml/kg/hr for 24 hours, or anuria for 12 hours). (2)\n* In ischemic kidney, there is acytokine belong to the transforming growth factor (TGF)-B ( Activin A) that regulates the growth and differantiation of cell in variuos organs was significantly increasd in ischemic kidney . (3)\n* level of Activin A in urine correlate to the severity of the acute kidney injury (AKI), as the level of urinary Activin A in first stages of acute kidney injury is less than the second and third stages . (4)\n* so follow up of urinary Activin A in patients with acute kidney injury can be avery useful biomarker for assessement of severity of acute kidney injury. (4)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* level of Activin A in urine correlate to the severity of the acute kidney injury (AKI), as the level of urinary Activin A in first stages of acute kidney injury is less than the second and third stages . (4)\n* so follow up of urinary Activin A in patients with acute kidney injury can be avery useful biomarker for assessement of severity of acute kidney injury', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include patient with acute kidney injury with no history of chronic kidney diseases\n\nExclusion Criteria:\n\n* patient with history of chronic kidney diseases , diseases associated with icreased activin A level such as ( heart failure , cancers , COPD , systemic sclerosis ,pregnant , viral infection , and Mycosis Fungoides and Sézary Syndrom'}, 'identificationModule': {'nctId': 'NCT06188533', 'briefTitle': 'Urinary Activin A as Apredictive Marker for Assessement of Acute Kidney Injury Severity in Patient Admitted at Assuit University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Urinary Activin A as Apredictive Marker for Assessement of Acute Kidney Injury Severity in Patient Admitted at Assuit University Hospital', 'orgStudyIdInfo': {'id': 'Urinary activin A in AKI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Urinary activin A in AKI', 'type': 'OTHER', 'description': 'Urinary activin A in AKI patient'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Kamal mahmoud mohamed amin', 'investigatorAffiliation': 'Assiut University'}}}}