Study of Suramin in Subjects With Furosemide-Resistant AKI
Purpose
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
- Acute Kidney Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Suramin |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
University of Arkansas Medical Sciences (UAMS)
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
California Institute of Renal Research
La Mesa, California 91942
La Mesa, California 91942
Emory University School of Medicine
Atlanta, Georgia 30303
Atlanta, Georgia 30303
University of New Mexico Health Science Center
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
New York-Presbyterian Medical Center of Queens
Flushing, New York 11355
Flushing, New York 11355
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157-1009
Winston-Salem, North Carolina 27157-1009
Southeast Renal Research Institute
Chattanooga, Tennessee 37404
Chattanooga, Tennessee 37404
Baylor Scott and White Research Institute - Dallas Clinical Trials Office
Dallas, Texas 75246
Dallas, Texas 75246
More Details
- NCT ID
- NCT04496596
- Status
- Recruiting
- Sponsor
- Rediscovery Life Sciences