Study of Suramin in Subjects With Furosemide-Resistant AKI

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rediscovery Life Sciences
• Treatments: Suramin

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.