Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06820567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2025-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects Dapagliflozin on Inflammatory Markers Erythropoiesis and Iron Metabolism in Patients with Type 2 Diabetes and CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GFR in CKD patients', 'timeFrame': '6 months', 'description': 'Measure eGFR using ckd epi equation to detect the effect of dapagliflozin in improvement of GFR in CKD patients'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Diabetes Type 2']}, 'referencesModule': {'references': [{'pmid': '38017482', 'type': 'BACKGROUND', 'citation': 'Koshino A, Neuen BL, Jongs N, Pollock C, Greasley PJ, Andersson EM, Hammarstedt A, Karlsson C, Langkilde AM, Wada T, Heerspink HJL. Effects of dapagliflozin and dapagliflozin-saxagliptin on erythropoiesis, iron and inflammation markers in patients with type 2 diabetes and chronic kidney disease: data from the DELIGHT trial. Cardiovasc Diabetol. 2023 Nov 28;22(1):330. doi: 10.1186/s12933-023-02027-8.'}]}, 'descriptionModule': {'briefSummary': 'the effect of Dapagliflozin on erythropoiesis, iron metabolism and inflammatory markers in CKD with Type 2 DM-Compare between effect of placebo and dapagliflozin on erythropoiesis, iron metabolism and inflammation markers in CKD with Type 2 DM.', 'detailedDescription': 'Type 2 diabetes is considered an important cause of chronic kidney diseases (CKD) ,in those patients the inflammation is the most assumed cause of the decrease in erythropoietin synthesis and abnormal iron metabolism leading to anemia (1\\_3).\n\nSodium glucose cotransporter 2 (SGLT2) inhibitors like Dapagliflozin are oral medications approved for type 2 diabetes. interestingly, during recent years, they have been promisingly considered as anew medications for cardiovascular and kidney diseases (4). Researchers suggested that SGLT 2 inhibitors play an important role in reducing CKD progression and renal failure with patients with type 2 DM based on the clinical outcomes and laboratory findings rather than completely understood mechanism (5\\_8)\n\nInvestigators reported that reduced transferrin saturation (TSAT), ferritin and hepcidin and circulating and urinary inflammatory mediators, including monocyte chemoattractant protein-1 (MCP -1 ) and interleukin-6 (IL-6) transiently increased EPO suggesting SGLT 2 inhibition may help iron utilization and promote erythropoiesis decreasing anemia ( 9-14)\n\nHere we are studying the effects of the SGLT 2 inhibitor Dapagliflozin regarding markers of erythropoiesis, iron metabolism and inflammation in patients with Type 2 DM and CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible participants were aged \\>18 years and diagnosed with Type 2 diabetes participants we required to have urinary albumin-creatinine ratio (UACR ) of 30\\_3500 mg /g ,eGFR of 20\\_ 80 ml/min/ 1.73 m , and HbA1c of 7.0 \\_ 11.0 % at screening\n\nExclusion Criteria:\n\ntype 1 diabetes, non-diabetes kidney disease and patient with HB \\< 9'}, 'identificationModule': {'nctId': 'NCT06820567', 'briefTitle': 'Effects Dapagliflozin on Inflammatory Markers Erythropoiesis and Iron Metabolism in Patients with Type 2 Diabetes and CKD', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'English Title of Research Project: Effects of Dapagliflozin on Inflammatory Markers, Erythropoiesis and Iron Metabolism in Patients with Type 2 Diabetes and CKD', 'orgStudyIdInfo': {'id': 'effect Dapagliflozin on CKD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'type 2 diabetic patients with chronic kidney diseases will recive dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin (DAPA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'type 2 diabetic patients with chronic kidney diseases will recive placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin (DAPA)', 'type': 'DRUG', 'description': 'patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients', 'armGroupLabels': ['Group A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'zeinab khodary, master', 'role': 'CONTACT', 'email': 'zynapkhodary@gmail.com', 'phone': '+201500009366'}, {'name': 'Mai Mostafa, MD', 'role': 'CONTACT', 'email': 'Mai_heamatology@aun.edu.eg', 'phone': '+201223971678'}], 'overallOfficials': [{'name': 'Mai Mostafa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor', 'investigatorFullName': 'Zeinab Khodary Saady Ali', 'investigatorAffiliation': 'Assiut University'}}}}