Acute Kidney Injury
Conditions
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.
Interventions
DRUGSuramin
Suramin is administered via IV infusion as a single dose of 3 mg/kg
DRUGPlacebo
Placebo
Sponsors
Rediscovery Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI | 7 days | The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7. |
Countries
United States
Outcome results
None listed