Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Suramin
  • Drug: Suramin
    Suramin is administered via IV infusion as a single dose of 3 mg/kg
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo

Recruiting Locations

Baylor Scott and White Research Institute - Dallas Clinical Trials Office
Dallas, Texas 75246
Contact:
Harold Szerlip, MD

More Details

NCT ID
NCT04496596
Status
Recruiting
Sponsor
Rediscovery Life Sciences

Study Contact

Jeremy Whitson
423-943-4265
Jwhitson@nephrosynergy.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.