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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

Tracking Information
First Submitted Date  ICMJE January 6, 2018
First Posted Date  ICMJE January 19, 2018
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE May 24, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
Complete Recovery from Stage 2/3 Acute Kidney Injury at Day 14 [ Time Frame: 14 Days ]
To compare the rates of complete recovery (alive, free of dialysis and return of serum creatinine to <150% of reference baseline; equivalent to acute kidney disease (AKD) category 0) at Day 14 between the Reltecimod-treated patients and the placebo-treated patients
Change History Complete list of historical versions of study NCT03403751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2019)
  • 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.
  • 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
  • AKI-Free Days [ Time Frame: 28 Days ]
    To compare AKI-free days over 14 and 28 days, respectively between Reltecimod and placebo-treated patients
  • Time to Primary Endpoint [ Time Frame: 28 Days ]
    To compare time to primary endpoint between the Reltecimod and placebo-treated patients
  • 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
  • Survival Status [ Time Frame: 28 Days ]
    To compare survival status at 14 and 28 between the Reltecimod and placebo-treated patients
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • 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.
  • Complete Recovery from AKI at Day 28 [ Time Frame: 28 Days ]
    To compare the rates of complete recovery (alive, free of dialysis and return of serum creatinine to <150% of reference baseline; equivalent to acute kidney disease (AKD) category 0) at Day 28 between the Reltecimod-treated patients and the placebo-treated patients
  • Overall AKI Recovery (Complete and Partial) [ Time Frame: 28 Days ]
    To compare the rates of overall recovery defined as complete recovery or partial recovery at Days 14 and 28, respectively between Reltecimod and placebo-treated patients
  • Time to Complete AKI Recovery [ Time Frame: 28 Days ]
    To compare time to complete recovery from AKI between the Reltecimod and placebo-treated patients
  • Time to Overall AKI Recovery [ Time Frame: 28 Days ]
    To compare time to overall recovery from AKI between the Reltecimod and placebo-treated patients
  • Incidence of AKI Stages in Abdominal Sepsis [ Time Frame: 7 Days ]
    Tabulate the number of patients with abdominal sepsis who have Stages 1, 2 and 3 AKI (using the KDIGO criteria)
  • Survival Status [ Time Frame: 28 Days ]
    To compare survival status at Days 14 and 28 between the Reltecimod and placebo-treated patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Official Title  ICMJE 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)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Acute Kidney Injury
  • Peritonitis
  • Necrotizing Soft Tissue Infection
Intervention  ICMJE
  • Drug: Reltecimod
    Single IV administration of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
    Other Name: AB103
  • 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
Study Arms  ICMJE
  • Experimental: Reltecimod
    Single dose
    Intervention: Drug: Reltecimod
  • Placebo Comparator: 0.9% Sodium Chloride Injection
    Single dose
    Intervention: Drug: 0.9% Sodium Chloride Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 11, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Wilfret, MD 919 439-3400 davidw@atoxbio.com
Contact: Wayne M Dankner, MD 919 439-3410 wayned@atoxbio.com
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03403751
Other Study ID Numbers  ICMJE ATB-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Atox Bio Ltd
Study Sponsor  ICMJE Atox Bio Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Azra Bihorac, MD University of Florida Health
PRS Account Atox Bio Ltd
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP