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Study of Suramin in Subjects With Furosemide-Resistant AKI

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ClinicalTrials.gov Identifier: NCT04496596
Recruitment Status : Not yet recruiting
First Posted : August 3, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Rediscovery Life Sciences

Tracking Information
First Submitted Date  ICMJE July 29, 2020
First Posted Date  ICMJE August 3, 2020
Last Update Posted Date August 5, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Suramin in Subjects With Furosemide-Resistant AKI
Official Title  ICMJE A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • Drug: Suramin
    Suramin is administered via IV infusion as a single dose of 3 mg/kg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Suramin
    Intervention: Drug: Suramin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2020)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeremy Whitson 423-943-4265 Jwhitson@nephrosynergy.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04496596
Other Study ID Numbers  ICMJE RLS003-02-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rediscovery Life Sciences
Study Sponsor  ICMJE Rediscovery Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rediscovery Life Sciences
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP