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EASE-AKI
NCT07661940Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2026
- Primary completion
- May 2029
- Countries
- 1
- Sponsor
- FAU Erlangen-Nürnberg Medical Faculty
- Drugs
- SP16-3M
- Conditions
- acute kidney injury (AKI)
01
Overview
Phase 2, randomised, double-blind trial in acute kidney injury (AKI) comparing SP16-3M with Placebo (2 arms). Primary endpoints: Frequency of adverse events and severe adverse events at 72 hours and Frequency of Cardiac Surgery Associated Acute Kidney Injury at 7 days. Started Sep 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
SP16-3M
SP16-3M 6 mg administered subcutaneously at two timepoints (pre-surgery and 9±1 h post-surgery).
Placebo
Placebo (dextrose 5%) administered subcutaneously at the same timepoints as the IMP.
03
Who it enrols
Adults with CKD Stage 2-3b scheduled for elective cardiac surgery using cardiopulmonary bypass, excluding those with severe heart failure, active infections, recent malignancies, or on immunosuppressive therapy.
04
Endpoints
Primary
Frequency of adverse events and severe adverse events
Frequency of Cardiac Surgery Associated Acute Kidney Injury
Secondary
Severity of post-surgical CSA-AKI
Duration of post-surgical CSA-AKI
Necessity of renal replacement therapy
Duration of renal replacement therapy
Cardiac function
Concentration of NT-proBNP
Central venous oxygen saturation
Frequency of all-cause death
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