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NCT Number: NCT06528405

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Szu-Yu Pan

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Albuminuria

    Time frame: Day 28 and Day 90

    The changes in albuminuria compared with baseline

  2. Discontinuation of SGLT2i

    Time frame: Day 0 to Day 90

    Development of adverse events leading to discontinuation of SGLT2i

Secondary outcomes

  1. eGFR

    Time frame: Day 28 to Day 84 or Day 28 to Day 168

    The changes in eGFR

  2. Major adverse kidney events

    Time frame: Day 0 to Day 180

    eGFR reduction >50%, dialysis, or death

  3. Major adverse cardiovascular events

    Time frame: Day 0 to Day 180

    hospitalization due to heart failure or death

  4. Death

    Time frame: Day 0 to Day 180

    All-cause mortality

  5. Amputation

    Time frame: Day 0 to Day 180

    Any amputation event

Study contacts

Contact information is provided by the study sponsor or research team.

Szu-Yu Pan, MD, PhD

CONTACT

[email protected]

+886-23123456 ext. 41845

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Chang Gung Memorial Hospital
  • China Medical University Hospital
  • National Cheng-Kung University Hospital

Registry information

Acronym: ESS-AKD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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