The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Szu-Yu Pan, MD, PhD
szuyupan@ntu.edu.tw
+886-23123456
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2027-12
Participants
Target number of participants: 264
Treatments
Experimental: SGLT2i
Placebo_comparator: Control
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital
Collaborators: China Medical University Hospital, Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov