Clinical trial NCT04496596: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Kidney Injury
Lead sponsor: Rediscovery Life Sciences
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences (UAMS)
state: Arkansas
city: La Mesa
country: United States
facility: California Institute of Renal Research
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Johns Creek
country: United States
facility: Emory Johns Creek Hospital
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Columbia
country: United States
facility: University of Missouri - Dept. of Surgery
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
city: Flushing
country: United States
facility: New York-Presbyterian Medical Center of Queens
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute - Dallas Clinical Trials Office
state: Texas
Study officials:
References: