Study of Suramin in Subjects With Furosemide-Resistant AKI

• ClinicalTrials.gov Identifier: NCT04496596
• Recruitment Status: Recruiting
• First Posted: August 3, 2020
• Last Update Posted: December 17, 2021
• Sponsor: Rediscovery Life Sciences
• Information provided by (Responsible Party): Rediscovery Life Sciences

Tracking Information

• First Submitted Date: July 29, 2020
• First Posted Date: August 3, 2020
• Last Update Posted Date: December 17, 2021
• Actual Study Start Date: November 13, 2020
• Estimated Primary Completion Date: August 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2020)

To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI [ Time Frame: 7 days ]

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Acute Kidney Injury

Intervention

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

Study Arms

• Experimental: Suramin
  Intervention: Drug: Suramin
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 29, 2020): 58
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2023
• Estimated Primary Completion Date: August 31, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jeremy Whitson; 423-943-4265; Jwhitson@nephrosynergy.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04496596
• Other Study ID Numbers: RLS003-02-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Rediscovery Life Sciences
• Study Sponsor: Rediscovery Life Sciences
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rediscovery Life Sciences
• Verification Date: December 2021