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

NCT06528405 | Recruiting Phase 2

• 1 other identifier: 202404095MINE
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Keywords

sodium-glucose cotransporter 2 inhibitor; acute kidney disease; albuminuria

Outcome Measures

Primary Outcomes (2)

• Albuminuria

  The changes in albuminuria compared with baseline

  Day 28 and Day 90

• Discontinuation of SGLT2i

  Development of adverse events leading to discontinuation of SGLT2i

  Day 0 to Day 90

Secondary Outcomes (5)

• eGFR

  Day 28 to Day 84 or Day 28 to Day 168

• Major adverse kidney events

  Day 0 to Day 180

• Major adverse cardiovascular events

  Day 0 to Day 180

• Death

  Day 0 to Day 180

• Amputation

  Day 0 to Day 180

Study Arms (2)

SGLT2i

EXPERIMENTAL

Drug: dapagliflozin; Drug: empagliflozin; Drug: canagliflozin

Control

PLACEBO COMPARATOR

Other: Other anti-diabetic drug or no anti-diabetic drug

Interventions

empagliflozin DRUG

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

SGLT2i

canagliflozin DRUG

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

SGLT2i

dapagliflozin DRUG

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

SGLT2i

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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• National Taiwan University Hospital: lead
• China Medical University Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Albuminuria

Interventions

dapagliflozin; empagliflozin; Canagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Szu-Yu Pan, MD, PhD

CONTACT

+886-23123456; szuyupan@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

TW (1)