Last updated on August 2019

Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury


Brief description of study

Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

Detailed Study Description

Phase 3 randomized, placebo controlled study assessing the efficacy (complete recovery from AKI) and safety of Reltecimod in patients with suspected or confirmed abdominal sepsis (planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures for control of underlying abdominal infection within 24 hours of evaluation by medical personnel) or patients with surgically confirmed necrotizing soft tissue infection (NSTI), requiring intensive care unit (ICU) or step down unit admission and in whom the diagnosis of Stage 2/3 acute kidney injury (AKI; as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria) is established at initial presentation for medical evaluation or up to 48 hours from the suspected diagnosis of abdominal sepsis or from surgically confirmed diagnosis of NSTI.

Clinical Study Identifier: NCT03403751

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Capital Health System, Inc.

Trenton, NJ United States
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Maricopa Medical Center

Phoenix, AZ United States
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UCSD Medical Center

San Diego, CA United States
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Harbor-UCLA Medical Center

Torrance, CA United States
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UCH-Memorial Health System

Colorado Springs, CO United States
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Yale New Haven Hospital

New Haven, CT United States
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Washington Hospital Center

Washington, WA United States
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UF Health Shands Hospital

Gainesville, FL United States
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University of Kentucky

Lexington, KY United States
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LSU Health Science Center

New Orleans, LA United States
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University of Michigan

Ann Arbor, MI United States
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Henry Ford Health System

Detroit, MI United States
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Hennepin County Medical Center

Minneapolis, MN United States
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University of Missouri

Columbia, MO United States
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Carolinas Medical Center

Charlotte, NC United States
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East Carolina University

Greenville, NC United States
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The Ohio State University

Columbus, OH United States
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The Trauma Center at PENN

Philadelphia, PA United States
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Thomas Jefferson University

Philadelphia, PA United States
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MUSC

Charleston, SC United States
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John Peter Smith Health Network

Fort Worth, TX United States
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Harborview Medical Center

Seattle, WA United States
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CHD Vendee

La Roche-sur-Yon, France
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