Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-02-21 @ 10:25 PM
Study NCT ID:
NCT06760650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005451', 'term': 'Fluorescein Angiography'}], 'ancestors': [{'id': 'D000792', 'term': 'Angiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum creatinine', 'timeFrame': 'At day 4', 'description': 'Change in serum creatinine from baseline to day 4'}], 'secondaryOutcomes': [{'measure': 'Long-term change in serum creatinine', 'timeFrame': '3 months', 'description': 'Change in serum creatinine from baseline to end of the third month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescein Angiography', 'Acute kidney injury', 'Chronic kidney disease', 'Diabetes'], 'conditions': ['Chronic Kidney Disease Stage 4', 'Chronic Kidney Disease Stage 3B', 'Chronic Kidney Disease Stage 5', 'Diabetes Mellitus', 'Fluorescein Angiography', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. The objective is to determine the incidence, severity and risk factors associated with this deterioration to improve the care of this specific population.', 'detailedDescription': 'This study will assess the change in serum creatinine in patients with diabetes and advanced chronic kidney disease, after a fluorescein angiography. This is a before and after study that will include 35 patients from the department of ophtalmology over 6 months with a total follow-up for 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old with type 2 or type 1 diabetes and chronic kidney disease stage 3b to 5 (eGFR\\<45 mL/min/1.73 m2)\n\nExclusion Criteria:\n\n* Patients who do not give their consent\n* Patients who are allergic to fluorescein\n* Patients who are on dialysis\n* Patients who had fever, vomiting, diarrhea or any dehydration 48 hours before the intervention\n* Patients who had a treatment modification one week before the intervention'}, 'identificationModule': {'nctId': 'NCT06760650', 'acronym': 'Fluo-AKI', 'briefTitle': 'Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Joseph University'}, 'officialTitle': 'Fluorescein-Induced Acute Kidney Injury in Patients With Diabetes and Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'CEHDF 2587'}, 'secondaryIdInfos': [{'id': 'Tfem-2025-79', 'type': 'OTHER', 'domain': 'Faculty of Medicine, Saint Joseph University of Beirut'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluorescein angiography', 'description': 'Assessing serum creatinine before and after fluorescein angiography', 'interventionNames': ['Diagnostic Test: Fluorescein angiography']}], 'interventions': [{'name': 'Fluorescein angiography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Fluorescein fundus angiography'], 'description': 'Fluorescein angiography', 'armGroupLabels': ['Fluorescein angiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56100', 'city': 'Beirut', 'country': 'Lebanon', 'contacts': [{'name': 'Mabel AOUN, M.D., M.P.H.', 'role': 'CONTACT', 'email': 'aounmabel@yahoo.fr', 'phone': '+9613351588'}, {'name': 'Dania CHELALA, M.D.', 'role': 'CONTACT', 'email': 'dania.chelala@hotmail.com'}, {'name': 'Anthony NOHRA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine, Saint Joseph University of Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'Mabel AOUN, M.D., M.P.H.', 'role': 'CONTACT', 'email': 'aounmabel@yahoo.fr', 'phone': '+9613351588'}, {'name': 'Anthony NOHRA, Medical Student', 'role': 'CONTACT', 'email': 'anthony.nohra1@net.usj.edu.lb'}], 'overallOfficials': [{'name': 'Mabel AOUN, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Saint Joseph University of Beirut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Joseph University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mabel Aoun', 'investigatorAffiliation': 'Saint-Joseph University'}}}}