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

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ClinicalTrials.gov Identifier: NCT03403751
Recruitment Status : Terminated (Very slow enrollment of target patient population)
First Posted : January 19, 2018
Results First Posted : September 16, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Atox Bio Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Peritonitis Necrotizing Soft Tissue Infection Drug: Reltecimod 0.5 mg/kg Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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.
Primary Purpose: Treatment
Official Title: Phase 3 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)
Actual Study Start Date : May 24, 2018
Actual Primary Completion Date : December 14, 2019
Actual Study Completion Date : December 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Reltecimod 0.5 mg/kg
Single IV infusion of Reltecimod 0.5 mg/kg
Drug: Reltecimod 0.5 mg/kg
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes
Other Name: AB103 0.5 mg/kg

Placebo Comparator: Placebo
Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline)
Drug: Placebo
Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
Other Name: 0.9% Sodium Chloride Injection (Normal saline)




Primary Outcome Measures :
  1. Freedom From Durable Loss of Renal Function at Day 28 [ Time Frame: 28 Days ]
    Freedom from durable loss of renal function at Day 28 required all of the following 3 components: alive at Day 28, free of dialysis at Day 28, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 28 from patient reference eGFR (measured by Modification of Diet in Renal Disease [MDRD] formula).

  2. Serious Adverse Events (SAEs) [ Time Frame: 28 Days ]
    Number of patients experiencing at least one SAE

  3. Adverse Events (AEs) [ Time Frame: 28 Days ]
    The number of patients experiencing at least one AE.


Secondary Outcome Measures :
  1. Freedom From Durable Loss of Renal Function at Day 14 [ Time Frame: 14 Days ]
    Freedom from durable loss of renal function at Day 14 required all of the following 3 components: alive at Day 14, free of dialysis at Day 14, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 14 from patient reference eGFR (measured by Modification of Diet in Renal Disease [MDRD] formula).

  2. Intensive Care Unit (ICU)-Free Days [ Time Frame: 28 Days ]
    ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.

  3. Ventilator-free Days [ Time Frame: 28 Days ]
    Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.

  4. Vasopressor-free Days [ Time Frame: 28 Days ]
    Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.

  5. Hospital Days [ Time Frame: 90 Days ]
    Hospital days refers to the number of days a patient spent time in the hospital.

  6. Cumulative Number of Deaths [ Time Frame: 90 Days ]
    The number of deaths occurring through Day 90

  7. Secondary Infections [ Time Frame: 28 Days ]
    Number of patients experiencing at least one secondary infection

  8. ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category [ Time Frame: 28 Days ]
    The number of days a patient did not spend in the ICU through Day 28, by mSOFA category (mSOFA total score of 1 or less; mSOFA total score of 2 or more). Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.

  9. Ventilator-free Days by Day 14 mSOFA Category [ Time Frame: 28 Days ]
    The number of days a patient was not on a ventilator through Day 28, by mSOFA category

  10. Vasopressor-free Days by Day 14 mSOFA Category [ Time Frame: 28 Days ]
    The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category

  11. Hospital Days by Day 14 mSOFA Category [ Time Frame: 90 Days ]
    The number of days a patient was in the hospital.

  12. Hospital Discharge Location by Day 14 mSOFA Category [ Time Frame: 90 Days ]
    Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other) among patients alive at Day 14.


Other Outcome Measures:
  1. Cumulative Mortality by Day 14 mSOFA Category [ Time Frame: 90 Days ]
    Percentage of patients who died through Day 90 using life table analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403751


Locations
Show Show 56 study locations
Sponsors and Collaborators
Atox Bio Ltd
Investigators
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Principal Investigator: Azra Bihorac, MD University of Florida Health
  Study Documents (Full-Text)

Documents provided by Atox Bio Ltd:
Study Protocol  [PDF] July 31, 2019
Statistical Analysis Plan  [PDF] January 6, 2020

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Responsible Party: Atox Bio Ltd
ClinicalTrials.gov Identifier: NCT03403751    
Other Study ID Numbers: ATB-203
First Posted: January 19, 2018    Key Record Dates
Results First Posted: September 16, 2021
Last Update Posted: October 12, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atox Bio Ltd:
Abdominal sepsis
AKI
NSTI
Additional relevant MeSH terms:
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Sepsis
Peritonitis
Soft Tissue Infections
Acute Kidney Injury
Wounds and Injuries
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases