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Study of Suramin in Subjects With Furosemide-Resistant AKI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04496596
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : March 16, 2021
Information provided by (Responsible Party):
Rediscovery Life Sciences

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Suramin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI
Actual Study Start Date : November 13, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: Suramin Drug: Suramin
Suramin is administered via IV infusion as a single dose of 3 mg/kg

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04496596

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Contact: Jeremy Whitson 423-943-4265

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United States, Texas
Baylor Scott and White Research Institute - Dallas Clinical Trials Office Recruiting
Dallas, Texas, United States, 75246
Contact: Harold Szerlip, MD         
Sponsors and Collaborators
Rediscovery Life Sciences
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Responsible Party: Rediscovery Life Sciences Identifier: NCT04496596    
Other Study ID Numbers: RLS003-02-001
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antinematodal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents