Study of Suramin in Subjects With Furosemide-Resistant AKI

NCT04496596 | Unknown Phase 2 FDA Drug

• 1 other identifier: RLS003-02-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 12

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Suramin

EXPERIMENTAL

Drug: Suramin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Suramin DRUG

Suramin is administered via IV infusion as a single dose of 3 mg/kg

Suramin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rediscovery Life Sciences: lead

Study Sites (12)

University of Arkansas Medical Sciences (UAMS)

Little Rock, Arkansas, 72205, United States

Location

California Institute of Renal Research

La Mesa, California, 91942, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 900953, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Missouri - Dept. of Surgery

Columbia, Missouri, 65212, United States

Location

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

Location

New York-Presbyterian Medical Center of Queens

Flushing, New York, 11355, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157-1009, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, 37404, United States

Location

Baylor Scott and White Research Institute - Dallas Clinical Trials Office

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Suramin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: November 13, 2020
• Primary Completion: April 17, 2023
• Study Completion: December 22, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)