Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Condition: Acute Kidney Injury; Peritonitis; Necrotizing Soft Tissue Infection
MeSH terms: Sepsis; Peritonitis; Soft Tissue Infections; Acute Kidney Injury; Wounds and Injuries
Intervention: Reltecimod 0.5 mg/kg; Placebo
Intervention description: Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes; Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 randomization of study drug (Reltecimod) and placebo (normal saline)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor personnel and clinical research associates (CRAs) will also be blinded to study treatment.
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Abdominal sepsis; AKI; NSTI

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has either suspected or documented diagnosis of abdominal sepsis requiring treatment
             with parenteral antibiotics and planned or completed surgical (laparotomy or
             laparoscopy) or interventional radiologic procedures within 24 hours of evaluation by
             medical personnel. Recommended surgical or interventional radiologic procedures be
             performed with 12 hours of evaluation by medical personnel.

          2. Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria established
             either upon presentation to medical care in those patients with suspected abdominal
             sepsis or in those patients in whom the initial diagnosis of AKI is established during
             the 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 a
                  surgical or interventional radiology procedure for the abdominal infection OR

               -  After confirmed diagnosis of abdominal infection has been established by a
                  surgical or interventional radiology procedure

        Exclusion Criteria:

          1. Has known prior history of chronic kidney disease (CKD( with a documented estimated
             GFR (eGFR) < 30 mL/min

             • Exception: Patients with history of CKD but no available prior eGFR who have
             documented 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 the
             time of AKI diagnosis

          5. Patient is not expected to survive throughout 28 days of study due to significant
             underlying medical condition

          6. Any concurrent medical condition, which in the opinion of the Investigator, may
             compromise the safety of the patient or the objectives of the study or the patient
             will 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 for
                  Chronic Obstructive Lung Disease - stage IV. or chronic hypoxemia)

               -  Liver dysfunction {Childs-Pugh class C}

               -  Primary or acquired immunodeficiency or immunosuppression due to treatment with
                  immunosuppressive 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, uncomplicated
             appendicitis, or cholangitis or cholecystitis without peritonitis;

          8. Pregnant or lactating women

          9. Concurrent or previous enrollment in a clinical trial involving investigational drug
             or a medical device