Acute Kidney Injury
Conditions
Keywords
sodium-glucose cotransporter 2 inhibitor, acute kidney disease, albuminuria
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.
Interventions
DRUGdapagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
OTHEROther 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.
DRUGempagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
DRUGcanagliflozin
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Sponsors
Chang Gung Memorial Hospital
China Medical University Hospital
National Cheng-Kung University Hospital
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and \< 80 years * 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
* Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within 28 days 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Albuminuria | Day 28 and Day 90 | The changes in albuminuria compared with baseline |
| Discontinuation of SGLT2i | Day 0 to Day 90 | Development of adverse events leading to discontinuation of SGLT2i |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | Day 0 to Day 180 | hospitalization due to heart failure or death |
| eGFR | Day 28 to Day 84 or Day 28 to Day 168 | The changes in eGFR |
| Amputation | Day 0 to Day 180 | Any amputation event |
| Death | Day 0 to Day 180 | All-cause mortality |
| Major adverse kidney events | Day 0 to Day 180 | eGFR reduction \>50%, dialysis, or death |
Countries
Taiwan
Contacts
Primary ContactSzu-Yu Pan, MD, PhD
Outcome results
None listed