Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-12 @ 11:57 AM
Study NCT ID:
NCT06528405
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D000419', 'term': 'Albuminuria'}], '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': 'D011507', 'term': 'Proteinuria'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000068896', 'term': 'Canagliflozin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Albuminuria', 'timeFrame': 'Day 28 and Day 90', 'description': 'The changes in albuminuria compared with baseline'}, {'measure': 'Discontinuation of SGLT2i', 'timeFrame': 'Day 0 to Day 90', 'description': 'Development of adverse events leading to discontinuation of SGLT2i'}], 'secondaryOutcomes': [{'measure': 'eGFR', 'timeFrame': 'Day 28 to Day 84 or Day 28 to Day 168', 'description': 'The changes in eGFR'}, {'measure': 'Major adverse kidney events', 'timeFrame': 'Day 0 to Day 180', 'description': 'eGFR reduction \\>50%, dialysis, or death'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': 'Day 0 to Day 180', 'description': 'hospitalization due to heart failure or death'}, {'measure': 'Death', 'timeFrame': 'Day 0 to Day 180', 'description': 'All-cause mortality'}, {'measure': 'Amputation', 'timeFrame': 'Day 0 to Day 180', 'description': 'Any amputation event'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sodium-glucose cotransporter 2 inhibitor', 'acute kidney disease', 'albuminuria'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Acute kidney disease (AKD) happens between 7 and 90 days after an initial kidney injury (AKI). This period is crucial because it can determine whether the condition worsens into chronic kidney disease (CKD). Despite knowing this, there is no proven treatment to improve outcomes for people with AKD.\n\nRecent studies have shown that drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors can slow down the worsening of chronic kidney disease, help with heart failure, and reduce the risk of death. Now, researchers are looking into whether these drugs can also help prevent acute kidney injury (AKI) and improve outcomes for AKD patients.\n\nOur project will explore the use of SGLT2 inhibitors in patients with AKD, with the belief that these drugs can safely reduce the amount of protein (albumin) in the urine and improve kidney health. To address this, investigators plan to conduct a large, multicenter study in Taiwan. This study will be randomized and placebo-controlled, meaning some patients will receive the SGLT2 inhibitors while others will receive a placebo (a harmless, inactive substance). Investigators will include AKD patients with and without diabetes, focusing on reducing the protein in their urine and monitoring for any serious side effects.\n\nThe goal of this trial is to provide strong evidence on whether SGLT2 inhibitors can be an effective treatment for AKD. If successful, this could offer a new strategy to prevent the progression from AKI to CKD and improve the health and outcomes of patients with kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years and \\< 80 years\n* Diagnosed with acute kidney disease\n* Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m²\n* Albuminuria \\> 100 mg/g or proteinuria \\> 300 mg/g (adjusted by urine creatinine)\n* Diagnosed with diabetes or chronic kidney disease\n\nExclusion Criteria:\n\n* Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within 28 days prior to enrollment\n* Patients with type 1 diabetes\n* Receiving aggressive immunosuppressive therapy for glomerulonephritis\n* Obstructive nephropathy\n* Polycystic kidney disease\n* Malignancy within 3 months or expected to undergo aggressive treatment such as chemotherapy, radiation therapy, immunotherapy, or targeted therapy in the future\n* Pregnant or breastfeeding women\n* Clinically assessed as not having recovered from acute kidney injury\n* Clinically assessed as at high risk for complications related to SGLT2 inhibitors'}, 'identificationModule': {'nctId': 'NCT06528405', 'acronym': 'ESS-AKD', 'briefTitle': 'The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease', 'orgStudyIdInfo': {'id': '202404095MINE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGLT2i', 'interventionNames': ['Drug: dapagliflozin', 'Drug: empagliflozin', 'Drug: canagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Other anti-diabetic drug or no anti-diabetic drug']}], 'interventions': [{'name': 'dapagliflozin', 'type': 'DRUG', 'description': 'Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.', 'armGroupLabels': ['SGLT2i']}, {'name': 'Other anti-diabetic drug or no anti-diabetic drug', 'type': 'OTHER', 'description': 'Other anti-diabetic drug or no anti-diabetic drug for 90 days during the acute kidney disease period.\n\nOther anti-diabetic drug includes metformin, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitor, insulin, α-glucosidase inhibitors, thiazolidinediones, and glucagon-like peptide-1 receptor agonist.', 'armGroupLabels': ['Control']}, {'name': 'empagliflozin', 'type': 'DRUG', 'description': 'Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.', 'armGroupLabels': ['SGLT2i']}, {'name': 'canagliflozin', 'type': 'DRUG', 'description': 'Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.', 'armGroupLabels': ['SGLT2i']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Szu-Yu Pan', 'role': 'CONTACT', 'email': 'szuyupan@ntu.edu.tw'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Szu-Yu Pan, MD, PhD', 'role': 'CONTACT', 'email': 'szuyupan@ntu.edu.tw', 'phone': '+886-23123456', 'phoneExt': '41845'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'China Medical University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}