Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT06187493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Diabetic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D004656', 'term': 'Enalapril'}, {'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C570240', 'term': 'empagliflozin'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevention of the development of DKD and alter its natural progression.', 'timeFrame': 'baseline≥3 months-year', 'description': 'Primary Outcome:\n\nTime to development of DKD: Measured as the time from randomization to the first occurrence of any of the following events:\n\nSustained (≥3 months) albumin-to-creatinine ratio (UACR) ≥300 mg/g End-stage kidney disease (ESKD) requiring dialysis or kidney transplantation\n\nMeasurement Tools:\n\nUACR: Measured in urine samples using commercial laboratory assays. eGFR: Estimated using creatinine levels and demographic data through formulas like CKD-EPI.\n\nCardiovascular events and mortality: Ascertained through medical records and national death registries.\n\nUnit of Measure:\n\nTime to DKD development: Years or months Change in UACR: mg/g eGFR decline: mL/min/1.73 m² per year Cardiovascular events and mortality: Incidence per 70patient-years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Efficacy of ACEi versus SGLT2i'], 'conditions': ['Diabetic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Due to irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns. So, this study aimed to compare the effectiveness of SGlT2i versus ACEi in the progression of diabetic kidney disease including progression of albuminuria. Doubling of serum creatinine and need for renal replacement therapy', 'detailedDescription': 'Diabetic kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide and continues to be the major contributor to kidney replacement therapy (KRT).\n\nDespite the significant decline in diabetes-related complications in recent decades, the same trend cannot be observed in chronic kidney disease (CKD) patients due to DKD that requires KRT. Hence, there exists a significant requirement for novel treatment approaches that can enhance glycemic control while minimizing the risk of hypoglycemia, as well as reducing cardiovascular and renal risks within this population. Irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns.\n\nACE inhibitors may delay the progression of nephropathy and reduce the risks of cardiovascular events in hypertensive patients with diabetes mellitus type I and type II.\n\nSGLT2i have become the new standard of care for slowing CKD progression in patients with type 2 diabetes mellitus (T2DM, due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects.\n\nResearch questions:\n\nQ1. Is there a significant effect of ACEi in treatment of patients with diabetic kidney disease.\n\nQ2: Is there is a significant effect of SGLT2i in treatment of patients with diabetic kidney disease.\n\nQ3: Which is more significantly efficient in treatment of patients with diabetic kidney disease (ACEi versus SGLT2i)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that suffer from Diabetic kidney disease (DKD)\n\nExclusion Criteria:\n\n* Genital mycotic infections\n* Urosepsis and Pyelonephritis\n* Lower limb amputation\n* diabetic Ketoacidosis\n* Euglycemic DKA\n* Acute Kidney Injury\n* Hypoglycemia\n* Fournier Gangrene\n* Hypersensitivity Reactions\n* Bone fracture\n* Bladder cancer\n* Hyperkalemia\n* Dyslipidemia'}, 'identificationModule': {'nctId': 'NCT06187493', 'briefTitle': 'Treatment of Patients With Diabetic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Efficacy of ACEi Versus SGLT2i in the Treatment of Patients With Diabetic Kidney Disease : Head to Head RCT', 'orgStudyIdInfo': {'id': 'diabetic kidney'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Efficacy of ACEi', 'description': 'Patients receive an ACEi medication, such as lisinopril, enalapril, or ramipril. These drugs work by blocking the production of angiotensin II, a hormone that can constrict blood vessels and raise blood pressure.', 'interventionNames': ['Drug: lisinopril, enalapril']}, {'type': 'OTHER', 'label': 'Efficacy of SGLT2i', 'description': 'Patients receive an SGLT2i medication, such as dapagliflozin, empagliflozin, or canagliflozin. These drugs work by preventing the kidneys from reabsorbing glucose from the urine, leading to lower blood sugar levels and potentially reducing the risk of kidney damage.', 'interventionNames': ['Drug: dapagliflozin, empagliflozin']}], 'interventions': [{'name': 'lisinopril, enalapril', 'type': 'DRUG', 'description': '1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both.\n2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications.\n3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.', 'armGroupLabels': ['Efficacy of ACEi']}, {'name': 'dapagliflozin, empagliflozin', 'type': 'DRUG', 'description': '1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both.\n2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications.\n3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.', 'armGroupLabels': ['Efficacy of SGLT2i']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ismael alaraby', 'role': 'CONTACT', 'email': 'drismael83@yahoo.com', 'phone': '+201007967808'}], 'overallOfficials': [{'name': 'Mohammed El-Tohamy, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Walaa khalifa, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Health Affairs Directorate', 'investigatorFullName': 'Ismael ahmed amin mohammed alaraby', 'investigatorAffiliation': 'Assiut University'}}}}