Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-29 @ 5:38 AM
Study NCT ID:
NCT04278495
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renographic glomerular filtration rate of the affected kidney.', 'timeFrame': '3 months', 'description': 'assessed by radioisotope renography using 99mTc-mercaptoacetyltriglycine (99mTc-MAG3) in ml/min'}], 'secondaryOutcomes': [{'measure': 'Serum creatinine change', 'timeFrame': '3 months', 'description': 'assessed by serum creatnine in mg/dl'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Losartan Adverse Reaction', 'Uropathy', 'Uropathy Obstructive']}, 'descriptionModule': {'briefSummary': 'Previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. Nevertheless, these witnessed effects have not been yet translated into the clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anuric and oliguric patients\n* calculuar ureteral obstruction\n\nExclusion Criteria:\n\n* anomalous kidney\n* bilateral obstructed kidney\n* history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors\n* ASA score of \\>3'}, 'identificationModule': {'nctId': 'NCT04278495', 'briefTitle': 'The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney: A Double Blind Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'LOSARTAN.OBST.UROPATHY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Losartan', 'description': 'to receive the medication Cozaar (Losartan Potassium 25mg "Merck Sharp \\& Dohme-UK"),', 'interventionNames': ['Drug: Cozaar (Losartan Potassium 25mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'to receive either placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cozaar (Losartan Potassium 25mg)', 'type': 'DRUG', 'otherNames': ['Cozaar'], 'description': 'Cozaar (Losartan Potassium 25mg)', 'armGroupLabels': ['Losartan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Outside U.S./Canada', 'country': 'Egypt', 'facility': 'Urology and nephrology center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed Shokier', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}