Study of Suramin in Subjects With Furosemide-Resistant AKI

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT04496596

Run by

Rediscovery Life Sciences

People needed

68

Starts

2020-11-13

Expected to finish

2023-12-22

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas Medical Sciences (UAMS) — Little Rock, Arkansas, United States
• California Institute of Renal Research — La Mesa, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Emory Johns Creek Hospital — Johns Creek, Georgia, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Missouri - Dept. of Surgery — Columbia, Missouri, United States
• University of New Mexico Health Science Center — Albuquerque, New Mexico, United States
• New York-Presbyterian Medical Center of Queens — Flushing, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Southeast Renal Research Institute — Chattanooga, Tennessee, United States
• Baylor Scott and White Research Institute - Dallas Clinical Trials Office — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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