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
Baylor Scott and White Research Institute - Dallas Clinical Trials Office
Dallas, Texas 75246
Dallas, Texas 75246
Contact:
Harold Szerlip, MD
Harold Szerlip, MD
More Details
- NCT ID
- NCT04496596
- Status
- Recruiting
- Sponsor
- Rediscovery Life Sciences