Status:
UNKNOWN
Study of Suramin in Subjects With Furosemide-Resistant AKI
Lead Sponsor:
Rediscovery Life Sciences
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Disea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04496596
Start Date
November 13 2020
End Date
December 22 2023
Last Update
May 3 2023
Active Locations (12)
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1
University of Arkansas Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
2
California Institute of Renal Research
La Mesa, California, United States, 91942
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 900953
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30303