Using SGLT2 inhibitors to treat acute kidney disease
The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
This study is testing whether SGLT2 inhibitors can help people with acute kidney disease by reducing protein in their urine and improving kidney health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06528405 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients diagnosed with acute kidney disease (AKD). Researchers aim to determine if these medications can reduce protein levels in urine and improve kidney health during the critical period following an acute kidney injury. The study will be randomized and placebo-controlled, involving multiple centers in Taiwan, and will include various SGLT2 inhibitors such as dapagliflozin, empagliflozin, and canagliflozin. The goal is to provide a potential treatment option for patients who currently have limited options for improving outcomes in AKD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of acute kidney disease and specific levels of kidney function and albuminuria.
Not a fit: Patients with type 1 diabetes, those who have recently used SGLT2 inhibitors, or individuals with certain kidney conditions or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to improve kidney health and outcomes for patients with acute kidney disease.
How similar studies have performed: Other studies have shown that SGLT2 inhibitors can be effective in managing chronic kidney disease, suggesting potential for success in this novel application for acute kidney disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Szu-Yu Pan, MD, PhD
- Email: szuyupan@ntu.edu.tw
- Phone: +886-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.