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

Inclusion Criteria:

1. Has either suspected or documented diagnosis of abdominal sepsis requiring treatmentwith parenteral antibiotics and planned or completed surgical (laparotomy orlaparoscopy) or interventional radiologic procedures within 24 hours of evaluation bymedical personnel. Recommended surgical or interventional radiologic procedures beperformed with 12 hours of evaluation by medical personnel.
2. Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria establishedeither upon presentation to medical care in those patients with suspected abdominalsepsis or in those patients in whom the initial diagnosis of AKI is established duringthe 48 hour period from the suspected diagnosis of abdominal sepsis.
3. Study medication must be administered within 6 hours of confirmation of onset of Stage 2 or 3 AKI as established at the study site, under the following criteria:

• After the decision is made by the attending surgeon at the study site for asurgical or interventional radiology procedure for the abdominal infection OR
• After confirmed diagnosis of abdominal infection has been established by asurgical or interventional radiology procedure

Exclusion Criteria:

1. Has known prior history of chronic kidney disease (CKD( with a documented estimatedGFR (eGFR) < 30 mL/min • Exception: Patients with history of CKD but no available prior eGFR who havedocumented normal kidney size on ultrasound or computed tomography evaluation (performed within 90 days of screening) will be eligible
2. Patients receiving renal replacment therapy (RRT) for CKD
3. . Previously diagnosed with documented AKI in the last 30 days
4. Documented primary glomerular disease or toxic tubulo-interstitial nephritis at thetime of AKI diagnosis
5. Patient is not expected to survive throughout 28 days of study due to significantunderlying medical condition
6. Any concurrent medical condition, which in the opinion of the Investigator, maycompromise the safety of the patient or the objectives of the study or the patientwill not benefit from treatment such as:

• Congestive heart failure (CHF) {New York Heart Association (NYHA) class III-IV}
• Severe chronic obstructive pulmonary disease (COPD) {GOLD - Global Initiative forChronic Obstructive Lung Disease - stage IV. or chronic hypoxemia)
• Liver dysfunction {Childs-Pugh class C}
• Primary or acquired immunodeficiency or immunosuppression due to treatment withimmunosuppressive medications
• Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes
• Neutropenia < 1,000 cells/mm3 not due to the underlying infection
• Receiving or about to receive chemotherapy or biologic anti-cancer treatment,
• Hematological and lymphatic malignancies in the last 5 years

7. Patient has acute pancreatitis with no established source of infection, uncomplicatedappendicitis, or cholangitis or cholecystitis without peritonitis;
8. Pregnant or lactating women
9. Concurrent or previous enrollment in a clinical trial involving investigational drugor a medical device