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

NCT ID: NCT06528405

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SGLT2i

Group Type EXPERIMENTAL

dapagliflozin

Intervention Type DRUG

Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

empagliflozin

Intervention Type DRUG

Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

canagliflozin

Intervention Type DRUG

Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

Control

Group Type PLACEBO_COMPARATOR

Other anti-diabetic drug or no anti-diabetic drug

Intervention Type 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.

Interventions

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dapagliflozin

Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

Intervention Type DRUG

Other 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.

Intervention Type OTHER

empagliflozin

Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

Intervention Type DRUG

canagliflozin

Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Szu-Yu Pan, MD, PhD

Role: CONTACT

+886-23123456 ext. 41845

Facility Contacts

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Szu-Yu Pan

Role: primary

Other Identifiers

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202404095MINE

Identifier Type: -

Identifier Source: org_study_id

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