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

Sponsor
National Taiwan University Hospital
Study ID
NCT06528405
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
  • Other anti-diabetic drug or no anti-diabetic drug — OTHER
    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 — DRUG
    Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
  • canagliflozin — DRUG
    Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

Study Details

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.

Key Dates

Start date
Nov 21, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SGLT2i
  • Placebo Comparator: Control

Primary Outcome Measure

Albuminuria [ Time Frame: Day 28 and Day 90 ]

Central Contacts

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