Study of Suramin in Subjects With Furosemide-Resistant AKI

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04496596
• Other study ID #: RLS003-02-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 13, 2020
• Est. completion date: December 22, 2023

Study information

• Verified date: May 2023
• Source: Rediscovery Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: December 22, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Suramin
Suramin is administered via IV infusion as a single dose of 3 mg/kg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	University of Missouri - Dept. of Surgery	Columbia	Missouri
United States	Baylor Scott and White Research Institute - Dallas Clinical Trials Office	Dallas	Texas
United States	New York-Presbyterian Medical Center of Queens	Flushing	New York
United States	Emory Johns Creek Hospital	Johns Creek	Georgia
United States	California Institute of Renal Research	La Mesa	California
United States	University of Kentucky	Lexington	Kentucky
United States	University of Arkansas Medical Sciences (UAMS)	Little Rock	Arkansas
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Rediscovery Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days