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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 : Recruiting
First Posted : January 19, 2018
Last Update Posted : August 7, 2019
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 Drug: 0.9% Sodium Chloride Injection 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)
Estimated Enrollment : 120 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 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Reltecimod
Single dose
Drug: Reltecimod
Single IV administration of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Other Name: AB103

Placebo Comparator: 0.9% Sodium Chloride Injection
Single dose
Drug: 0.9% Sodium Chloride Injection
Single IV administration of 0.5 mL/kg of 0.9% saline (volume equivalent with Reltecimod dosing schema)
Other Name: Normal saline




Primary Outcome Measures :
  1. Freedom from Durable loss of estimated Glomerular Filtration Rate (eGFR) in Stage 2/3 Sepsis-Associated Acute Kidney Injury at Day 28 [ Time Frame: 28 Days ]
    To compare the rates of freedom from durable loss of renal function (alive, free of dialysis and less than 37% loss of eGFR from patient reference eGFR (measured by MDRD formula) at Day 28 between the Reltecimod-treated patients and the placebo-treated patients


Secondary Outcome Measures :
  1. Safety of Reltecimod [ Time Frame: 28 Days ]
    Tabulate number of patients with treatment emergent adverse events and serious adverse events as well as those with laboratory abnormalities. Compare rates in Reltecimod-treated patients to placebo patients.

  2. Freedom from Durable Loss of eGFR at Day 14 [ Time Frame: 28 Days ]
    To compare the rates of primary endpoint (alive, free of dialysis and less than a 37% loss of eGFR at Day 14 between the Reltecimod-treated patients and the placebo-treated patients

  3. AKI-Free Days [ Time Frame: 28 Days ]
    To compare AKI-free days over 14 and 28 days, respectively between Reltecimod and placebo-treated patients

  4. Time to Primary Endpoint [ Time Frame: 28 Days ]
    To compare time to primary endpoint between the Reltecimod and placebo-treated patients

  5. Critical Care and Hospital Stay Parameters [ Time Frame: 28 Days ]
    To compare the effect of Reltecimod vs placebo on critical care and hospital stay parameters such as ICU and ICU-free days, ventilator and ventilator-free days, renal replacement therapy days, vasopressor and vasopressor-free days and hospital stay patients

  6. Survival Status [ Time Frame: 28 Days ]
    To compare survival status at 14 and 28 between the Reltecimod and placebo-treated patients



Information from the National Library of Medicine

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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 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 RRT for chronic kidney disease
  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 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


Contacts
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Contact: David Wilfret, MD 919 439-3400 davidw@atoxbio.com
Contact: Wayne M Dankner, MD 919 439-3410 wayned@atoxbio.com

  Show 48 Study Locations
Sponsors and Collaborators
Atox Bio Ltd
Investigators
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Principal Investigator: Azra Bihorac, MD University of Florida Health

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Responsible Party: Atox Bio Ltd
ClinicalTrials.gov Identifier: NCT03403751     History of Changes
Other Study ID Numbers: ATB-203
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
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
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases