Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

At least 18 years of age at the time of signing the informed consent
KDIGO Stage I AKI and a serum Cr increase ≥ 0.3 mg/dL within 48 hr or 1.5 to 1.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization OR KDIGO Stage II AKI and serum Cr increase 2.0 to 2.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization
Fails to achieve a 200 mL increase in urine output within 2 hr following a 1.0 mg/kg bolus of furosemide (i.e., positive FST)
If female of childbearing potential, must have a negative pregnancy test at Screening Is capable of providing informed consent as described in in this protocol.

Exclusion Criteria:

Receiving hemodialysis or peritoneal dialysis
Prior renal transplant (other organ transplants are not excluded)
Known baseline (pre-FST) estimated glomerular filtration rate (eGFR) ≤ 20 mL/min
Evidence of hydronephrosis or obstructive uropathy confirmed by renal ultrasound (for subjects without a documented ultrasound, the
Investigator will determine if a renal ultrasound is indicated, consistent with the standard of care (SOC)
Hepatic encephalopathy, Child class C cirrhosis, and/or clinical suspicion of hepatorenal syndrome
International normalized ratio (INR) ≤ 3.0, unless on stable long-term warfarin therapy within 2 weeks prior to randomization
Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
Known coronavirus (COVID-19) infection
White blood cell count (WBC) < 2,000/μL and/or platelet count < 30,000/μL at the time of Screening
A sequential organ failure assessment (SOFA) score > 10 during Screening
Subjects requiring 3 or more vasopressor agents of any combination to maintain a mean arterial pressure > 65 mm Hg
Unwilling to participate in follow-up phone surveys up to 180 days post-treatment
Are enrolled in another interventional research study or have participated in another interventional study within 14 days of Screening.