Study of Suramin in Subjects With Furosemide-Resistant AKI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2023-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Suramin

Group Type EXPERIMENTAL

Suramin

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Suramin

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No