A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI

Rediscovery Life Sciences12 sites in 1 country68 target enrollmentNovember 13, 2020

ConditionsAcute Kidney Injury

InterventionsSuramin Placebo

DrugsSuramin Placebo

Overview

Phase: Phase 2
Intervention: Suramin
Conditions: Acute Kidney Injury
Sponsor: Rediscovery Life Sciences
Enrollment: 68
Locations: 12
Primary Endpoint: To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 13, 2020

End Date

December 22, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rediscovery Life Sciences

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Suramin

Intervention: Suramin

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI

Time Frame: 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.