Study of Suramin in Subjects With Furosemide-Resistant AKI

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Placebo; Drug: Suramin

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jeremy Whitson; Phone Number: 423-943-4265; Email: Jwhitson@nephrosynergy.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas Medical Sciences (UAMS)
  • California
    • La Mesa, California, United States, 91942
      • California Institute of Renal Research
    • Los Angeles, California, United States, 900953
      • Ronald Reagan UCLA Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine
    • Johns Creek, Georgia, United States, 30097
      • Emory Johns Creek Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri - Dept. of Surgery
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Health Science Center
  • New York
    • Flushing, New York, United States, 11355
      • New York-Presbyterian Medical Center of Queens
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1009
      • Wake Forest Baptist Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Southeast Renal Research Institute
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott and White Research Institute - Dallas Clinical Trials Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Suramin	Drug: Suramin; Suramin is administered via IV infusion as a single dose of 3 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI	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.	7 days

Collaborators and Investigators

• Sponsor: Rediscovery Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): April 17, 2023
• Study Completion (Anticipated): December 22, 2023

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Anti-Infective Agents; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Trypanocidal Agents; Suramin
• Other Study ID Numbers: RLS003-02-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No