The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
NCT ID: NCT06528405
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
264 participants
INTERVENTIONAL
2024-11-21
2027-12-31
Brief Summary
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Recent 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.
Our 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.
The 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SGLT2i
dapagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
empagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
canagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Control
Other anti-diabetic drug or no anti-diabetic drug
Other anti-diabetic drug or no anti-diabetic drug for 90 days during the acute kidney disease period.
Other anti-diabetic drug includes metformin, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitor, insulin, α-glucosidase inhibitors, thiazolidinediones, and glucagon-like peptide-1 receptor agonist.
Interventions
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dapagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Other anti-diabetic drug or no anti-diabetic drug
Other anti-diabetic drug or no anti-diabetic drug for 90 days during the acute kidney disease period.
Other anti-diabetic drug includes metformin, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitor, insulin, α-glucosidase inhibitors, thiazolidinediones, and glucagon-like peptide-1 receptor agonist.
empagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
canagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with acute kidney disease
* Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m²
* Albuminuria \> 100 mg/g or proteinuria \> 300 mg/g (adjusted by urine creatinine)
* Diagnosed with diabetes or chronic kidney disease
Exclusion Criteria
* Patients with type 1 diabetes
* Receiving aggressive immunosuppressive therapy for glomerulonephritis
* Obstructive nephropathy
* Polycystic kidney disease
* Malignancy within 3 months or expected to undergo aggressive treatment such as chemotherapy, radiation therapy, immunotherapy, or targeted therapy in the future
* Pregnant or breastfeeding women
* Clinically assessed as not having recovered from acute kidney injury
* Clinically assessed as at high risk for complications related to SGLT2 inhibitors
18 Years
80 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
China Medical University Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202404095MINE
Identifier Type: -
Identifier Source: org_study_id
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