Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06897605
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D006397', 'term': 'Hematinics'}], 'ancestors': [{'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Erythropoiesis stimulating agent therapy dose', 'timeFrame': '12 weeks', 'description': 'Difference between two groups in comulative dose of erythropoiesis stimulating agent therapy (E.S.A) in international unit (I.U) at the end of the study.'}], 'secondaryOutcomes': [{'measure': 'Changes in hemoglobin level', 'timeFrame': '12 weeks', 'description': 'Difference between two groups in hemoglobin level in g/dL at the end of the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease(CKD)', 'Anemia, Kidney Disease, Chronic']}, 'descriptionModule': {'briefSummary': "Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Post hoc analyses of previous clinical trials have shown that patients treated with SGLT2 inhibitors exhibited higher levels of hemoglobin and hematocrit compared to those in the control group. These findings suggest that dapagliflozin's ability to elevate hemoglobin levels could potentially be utilized for the treatment of anemia in patients with chronic kidney disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Adults aged ≥ 18 years with CKD stage III or IV.\n2. Patients with anemia of CKD and a hemoglobin level \\< 11.5 g/dL\n3. Patients are receiving erythropoiesis-stimulating agent therapy.\n\nExclusion criteria\n\n1. Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.\n2. Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma.\n3. Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial.\n4. Patients with current malignancies or a history of malignancy within the past 2 years.\n5. Diagnosed with pure red cell aplasia.\n6. Patients with severe gastrointestinal bleeding.\n7. Pregnant or lactating females.'}, 'identificationModule': {'nctId': 'NCT06897605', 'briefTitle': 'Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': "2024-117'1"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin + ESA group', 'description': 'patients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA)', 'interventionNames': ['Drug: Dapagliflozin (DAPA)', 'Drug: Erythropoiesis Stimulating Agent']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'patients will receive standard care therapy of erythropoiesis-stimulating agents (ESA)', 'interventionNames': ['Drug: Erythropoiesis Stimulating Agent']}], 'interventions': [{'name': 'Dapagliflozin (DAPA)', 'type': 'DRUG', 'description': 'Dapagliflizin 10 mg tablets once daily for 12 weeks', 'armGroupLabels': ['Dapagliflozin + ESA group']}, {'name': 'Erythropoiesis Stimulating Agent', 'type': 'DRUG', 'description': 'Erythropoiesis stimulating agent (ESA) therapy', 'armGroupLabels': ['Control group', 'Dapagliflozin + ESA group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Basma M. Sayed Ahmed, M.Sc.', 'role': 'CONTACT', 'email': 'basma_mohamed@mans.edu.eg', 'phone': '+201207753307'}], 'overallOfficials': [{'name': 'Noha O. Mansour, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator-Associate Professor of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department', 'investigatorFullName': 'Noha Mansour', 'investigatorAffiliation': 'Mansoura University'}}}}