Last updated on May 2019

Phase 2 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury


Brief description of study

Phase 2 multicenter study to be conducted in up to 50 qualified participating sites in the United States to assess the efficacy and safety of Reltecimod vs placebo in patients with abdominal sepsis-associated Stage 2/3 AKI.

Detailed Study Description

Phase 2 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), 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.

Clinical Study Identifier: NCT03403751

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University of Missouri

Columbia, MO United States
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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