The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
- Conditions
- Acute Kidney Injury
- Interventions
- Other: Other anti-diabetic drug or no anti-diabetic drug
- Registration Number
- NCT06528405
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
- Age ≥ 18 years and < 80 years
- Diagnosed with acute kidney disease
- Estimated glomerular filtration rate (eGFR) between 20-75 mL/min/1.73m²
- Albuminuria > 100 mg/g or proteinuria > 300 mg/g (adjusted by urine creatinine)
- Diagnosed with diabetes
- Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within one month prior to enrollment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SGLT2i empagliflozin - Control Other anti-diabetic drug or no anti-diabetic drug - SGLT2i dapagliflozin - SGLT2i canagliflozin -
- Primary Outcome Measures
Name Time Method Discontinuation of SGLT2i Day 0 to Day 90 Development of adverse events leading to discontinuation of SGLT2i
Albuminuria Day 28 and Day 90 The changes in albuminuria compared with baseline
- Secondary Outcome Measures
Name Time Method Amputation Day 0 to Day 180 Any amputation event
Major adverse cardiovascular events Day 0 to Day 180 hospitalization due to heart failure or death
Major adverse kidney events Day 0 to Day 180 eGFR reduction \>50%, dialysis, or death
eGFR Day 28 to Day 84 or Day 28 to Day 168 The changes in eGFR
Death Day 0 to Day 180 All-cause mortality
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan