Study of Suramin in Subjects With Furosemide-Resistant AKI

A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI

Sponsors

Lead Sponsor: Rediscovery Life Sciences

Source Rediscovery Life Sciences
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.

Overall Status Not yet recruiting
Start Date September 2020
Completion Date May 2022
Primary Completion Date November 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI 7 days
Enrollment 58
Condition
Intervention

Intervention Type: Drug

Intervention Name: Suramin

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

Arm Group Label: Suramin

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo

Arm Group Label: Placebo

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Jeremy Whitson

Phone: 423-943-4265

Email: [email protected]

Location
Facility: Contact: Baylor Scott and White Research Institute - Dallas Clinical Trials Office Harold Szerlip, MD
Location Countries

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Suramin

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov