Summary

for people ages 18-80 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

Phase 2 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)

Details

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.

Keywords

Acute Kidney Injury Peritonitis Abdominal sepsis AKI Wounds and Injuries Sepsis Reltecimod 0.9% Sodium Chloride Injection

Eligibility

You can join if…

Open to people ages 18-80

  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:
  4. 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
  5. After confirmed diagnosis of abdominal infection has been established by a surgical or interventional radiology procedure

You CAN'T join if...

  1. Has known prior history of 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

  1. Patients receiving RRT for chronic kidney disease
  2. Patients that are treated with RRT for acute kidney dysfunction, starting prior to study drug administration or in whom there is an immediate plan to initiate RRT upon diagnosis of AKI
  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:
  7. Congestive heart failure (CHF) {New York Heart Association (NYHA) class III-IV}
  8. Severe chronic obstructive pulmonary disease (COPD) {GOLD stage III-IV. or chronic hypoxemia
  9. Liver dysfunction {Childs-Pugh class C}
  10. Primary or acquired immunodeficiency or immunosuppression due to treatment with immunosuppressive medications
  11. Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes
  12. Neutropenia < 1,000 cells/mm3 not due to the underlying infection
  13. Receiving or about to receive chemotherapy or biologic anti-cancer treatment,
  14. Hematological and lymphatic malignancies in the last 5 years
  15. Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis;
  16. Pregnant or lactating women
  17. . Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device

Locations

  • UCSD Medical Center accepting new patients
    San Diego California 92103 United States
  • Loma Linda University Medical Center not yet accepting patients
    Loma Linda California 92354 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Atox Bio Ltd
ID
NCT03403751
Phase
Phase 2
Study Type
Interventional
Last Updated