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ESS-AKD

RecruitingPhase 2

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

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Enrollment

264

estimated

Study population

Renal impairment

Key I/E criterion

eGFR ≥20

Primary endpoints

UACR, changeDiscontinuation due to AE

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06528405
Org study ID202404095MINE

Timeline

Milestones

Study first posted2024-07-30actual
Study start2024-11-21actual
Last update posted2026-01-02actual
Primary completion2027-07estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Renal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
3
Renal / kidney
3
Safety / tolerability / PK
1

Cardiovascular outcomes

3 endpoints
Secondary/protocol endpoint

Major adverse cardiovascular events

Time frame:Day 0 to Day 180

Expanded / custom MACE composite

composite event, event

componentsHeart-failure hospitalization, All-cause death

Secondary/protocol endpoint

Death

Time frame:Day 0 to Day 180

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Amputation

Time frame:Day 0 to Day 180

Major amputation

event count, event

Renal / kidney

3 endpoints
Primary/protocol endpoint

Albuminuria

Time frame:Day 28 and Day 90

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

eGFR

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

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Major adverse kidney events

Time frame:Day 0 to Day 180

Custom renal composite

composite event, event

componentseGFR, change, Kidney-replacement therapy, All-cause death

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Discontinuation of SGLT2i

Time frame:Day 0 to Day 90

Discontinuation due to AE

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.