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

Phase 2

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Other: Other anti-diabetic drug or no anti-diabetic drug; Drug: dapagliflozin; Drug: empagliflozin; Drug: canagliflozin

• Registration Number: NCT06528405
• Lead Sponsor: National Taiwan University Hospital

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.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Study Start: 2024-11-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Age ≥ 18 years and < 80 years
• Diagnosed with acute kidney disease
• Estimated glomerular filtration rate (eGFR) between 20-75 mL/min/1.73m²
• Albuminuria > 100 mg/g or proteinuria > 300 mg/g (adjusted by urine creatinine)
• Diagnosed with diabetes

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Exclusion Criteria

• Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within one month 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGLT2i	empagliflozin	-
Control	Other anti-diabetic drug or no anti-diabetic drug	-
SGLT2i	dapagliflozin	-
SGLT2i	canagliflozin	-

Primary Outcome Measures

Name	Time	Method
Discontinuation of SGLT2i	Day 0 to Day 90	Development of adverse events leading to discontinuation of SGLT2i
Albuminuria	Day 28 and Day 90	The changes in albuminuria compared with baseline

Secondary Outcome Measures

Name	Time	Method
Amputation	Day 0 to Day 180	Any amputation event
Major adverse cardiovascular events	Day 0 to Day 180	hospitalization due to heart failure or death
Major adverse kidney events	Day 0 to Day 180	eGFR reduction \>50%, dialysis, or death
eGFR	Day 28 to Day 84 or Day 28 to Day 168	The changes in eGFR
Death	Day 0 to Day 180	All-cause mortality

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan