Study of Suramin in Subjects With Furosemide-Resistant AKI

About

Brief Summary

This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI.

Primary Purpose

Prevention

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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.

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