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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.
 
ClinicalTrials.gov Identifier: NCT04496596
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : December 17, 2021
Sponsor:
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 : August 31, 2022
Estimated Study Completion Date : May 31, 2023

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
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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT04496596


Contacts
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Contact: Jeremy Whitson 423-943-4265 Jwhitson@nephrosynergy.com

Locations
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United States, Arkansas
University of Arkansas Medical Sciences (UAMS) Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Nithin Karakala, M.D.       nkarakala@uams.edu   
United States, California
California Institute of Renal Research Recruiting
La Mesa, California, United States, 91942
Contact: George Fadda, M.D.       gfadda@bnmg.org   
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30303
Contact: Michael Connor, M.D.       michael.connor@emory.edu   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Javier Neyra, M.D.       javier.neyra@uky.edu   
United States, New Mexico
University of New Mexico Health Science Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: J. Pedro Teixeira, M.D.       jteixeira@salud.unm.edu   
United States, New York
New York-Presbyterian Medical Center of Queens Recruiting
Flushing, New York, United States, 11355
Contact: Charytan, M.D.       cxcharyt@nyp.org   
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1009
Contact: Ashish Khanna, M.D.       akhanna@wakehealth.edu   
United States, Tennessee
Southeast Renal Research Institute Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Claude Galphin, MD       Dr.galphin@nephassociates.com   
United States, Texas
Baylor Scott and White Research Institute - Dallas Clinical Trials Office Recruiting
Dallas, Texas, United States, 75246
Contact: Gates Colbert, MD       Gates.Colbert@BSWHealth.org   
Sponsors and Collaborators
Rediscovery Life Sciences
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Responsible Party: Rediscovery Life Sciences
ClinicalTrials.gov Identifier: NCT04496596    
Other Study ID Numbers: RLS003-02-001
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 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
Suramin
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents