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Study of Suramin in Subjects With Furosemide-Resistant AKI

Primary Purpose

Acute Kidney Injury

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Suramin
Placebo
Sponsored by
Rediscovery Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arkansas Medical Sciences (UAMS)
  • California Institute of Renal Research
  • Ronald Reagan UCLA Medical Center
  • Emory University School of Medicine
  • Emory Johns Creek Hospital
  • University of Kentucky
  • University of Missouri - Dept. of Surgery
  • University of New Mexico Health Science Center
  • New York-Presbyterian Medical Center of Queens
  • Wake Forest Baptist Medical Center
  • Southeast Renal Research Institute
  • Baylor Scott and White Research Institute - Dallas Clinical Trials Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suramin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2020
Last Updated
May 1, 2023
Sponsor
Rediscovery Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04496596
Brief Title
Study of Suramin in Subjects With Furosemide-Resistant AKI
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rediscovery Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suramin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Suramin
Intervention Description
Suramin is administered via IV infusion as a single dose of 3 mg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
University of Arkansas Medical Sciences (UAMS)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
California Institute of Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
900953
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory Johns Creek Hospital
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Missouri - Dept. of Surgery
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New York-Presbyterian Medical Center of Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1009
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Baylor Scott and White Research Institute - Dallas Clinical Trials Office
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Suramin in Subjects With Furosemide-Resistant AKI

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