Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 8:44 AM
Study NCT ID:
NCT06865456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Survival of DKD Patients in Assiut University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], '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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of CKD in diabetic patients', 'timeFrame': 'baseline', 'description': 'pergentage of diabetic patients with stage 4,5 chronic kidney disease'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic nephropathy'], 'conditions': ['Chronic Kidney Disease(CKD)']}, 'descriptionModule': {'briefSummary': 'In recent years, the global prevalence of diabetes has risen significantly. According to the 9th edition of the International Diabetes Federation Atlas, an estimated 463 million adults were living with diabetes in 2019, representing approximately 9.3% of the population, with an average annual increase of 51%.\n\nDiabetes is associated with multiple complications that can significantly impact patient outcomes . In 2019 alone, around 4.2 million deaths were attributed to diabetes and its complications, accounting for approximately 11.3% of all global deaths .\n\nIn diabetic patients, several factors influence renal survival, including glycemic control, blood pressure management, lifestyle interventions, and pharmacological therapies such as renin-angiotensin-aldosterone system (RAAS) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists(9). Early detection of kidney dysfunction through biomarkers like estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR) plays a pivotal role in improving renal outcomes.\n\nThis study aims to evaluate the factors affecting Patients survival in diabetic patients, identify early predictors of renal function decline, and assess the effectiveness of current therapeutic strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'diabetic patients with chronic kideny disease stage 4,5', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ● Patients age \\> 18 years old\n\n * Both sex\n * diabetic patients with HbA1c level \\>6.5( Type 1 and 2)\n * Diabetic patients with CKD 4, 5 )\n * HD Pt\n\nExclusion Criteria:\n\n* ● Chronic kidney diseases stage 1,2, and 3.\n\n * Acute kidney injury.\n * Patients with any other causes of CKD autoimmune disease'}, 'identificationModule': {'nctId': 'NCT06865456', 'briefTitle': 'Predictors of Survival of DKD Patients in Assiut University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Predictors of Survival of DKD Patients in Assiut University Hospital', 'orgStudyIdInfo': {'id': 'DKD predictors'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'diapetic patient with diabetic nephropathy stage 4,5'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor at Assiut university hospital', 'investigatorFullName': 'Hasnaa Osama Hassan Reiad', 'investigatorAffiliation': 'Assiut University'}}}}