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Very slow enrollment of target patient population
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reltecimod 0.5 mg/kg | Experimental | Single IV infusion of Reltecimod 0.5 mg/kg |
|
| Placebo | Placebo Comparator | Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reltecimod 0.5 mg/kg | Drug | Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Durable Loss of Renal Function at Day 28 | 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). | 28 Days |
| Serious Adverse Events (SAEs) | Number of patients experiencing at least one SAE | 28 Days |
| Adverse Events (AEs) | The number of patients experiencing at least one AE. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Durable Loss of Renal Function at Day 14 | 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). | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Mortality by Day 14 mSOFA Category | Percentage of patients who died through Day 90 using life table analysis | 90 Days |
Inclusion Criteria:
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.
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.
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:
Exclusion Criteria:
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
Patients receiving renal replacment therapy (RRT) for CKD
. Previously diagnosed with documented AKI in the last 30 days
Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the time of AKI diagnosis
Patient is not expected to survive throughout 28 days of study due to significant underlying medical condition
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:
Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis;
Pregnant or lactating women
Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device
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| Name | Affiliation | Role |
|---|---|---|
| Azra Bihorac, MD | University of Florida Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Banner University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reltecimod 0.5 mg/kg | Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) |
| FG001 | Placebo | Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2019 | Aug 17, 2021 |
Not provided
1:1 randomization of study drug (Reltecimod) and placebo (normal saline)
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Sponsor personnel and clinical research associates (CRAs) will also be blinded to study treatment.
| Placebo | Drug | Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes |
|
|
| Intensive Care Unit (ICU)-Free Days | ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28. | 28 Days |
| Ventilator-free Days | Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28. | 28 Days |
| Vasopressor-free Days | Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28. | 28 Days |
| Hospital Days | Hospital days refers to the number of days a patient spent time in the hospital. | 90 Days |
| Cumulative Number of Deaths | The number of deaths occurring through Day 90 | 90 Days |
| Secondary Infections | Number of patients experiencing at least one secondary infection | 28 Days |
| ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category | 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. | 28 Days |
| Ventilator-free Days by Day 14 mSOFA Category | The number of days a patient was not on a ventilator through Day 28, by mSOFA category | 28 Days |
| Vasopressor-free Days by Day 14 mSOFA Category | The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category | 28 Days |
| Hospital Days by Day 14 mSOFA Category | The number of days a patient was in the hospital. | 90 Days |
| Hospital Discharge Location by Day 14 mSOFA Category | 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. | 90 Days |
| Tucson |
| Arizona |
| 24857 |
| United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| UCSD Medical Center | San Diego | California | 92103 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| UCH-Memorial Health System | Colorado Springs | Colorado | 80909 | United States |
| University of Colorado Hospital | Denver | Colorado | 80045 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| UF Health Shands Hospital | Gainesville | Florida | 32610 | United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| LSU Health Science Center | New Orleans | Louisiana | 70012 | United States |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | 55455 | United States |
| University of Missouri | Columbia | Missouri | 65211 | United States |
| Capital Health System, Inc. | Trenton | New Jersey | 98638 | United States |
| Erie County Medical Center-Affliate of SUNYat Buffalo | Buffalo | New York | 14215 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28208 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| University of Cincinnati Medical Center (UCMC) | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| The Pennsylvania State University and The Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| The Trauma Center at PENN | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| MUSC | Charleston | South Carolina | 29425 | United States |
| John Peter Smith Health Network | Fort Worth | Texas | 76104 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Hopital Victor Dupouy | Argenteuil | France |
| CHRU la Cavale Blanche | Brest | France |
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
| CHU Dijon | Dijon | France |
| CHD Vendee | La Roche-sur-Yon | France |
| CH Le Mans | Le Mans | France |
| Robert Salengro Hopital-CHRU Lille | Lille | France |
| CHU de Limoges | Limoges | France |
| CHU Lyon Sud | Lyon | France |
| Hopital Edouard Herriot | Lyon | France |
| Hopital Saint Eloi | Montpellier | France |
| CHU de Nante Hotel-Dieu | Nantes | France |
| CHU Nimes | Nîmes | France |
| Hopital Cochin | Paris | France |
| CHU Rennes | Rennes | France |
| Nouvel Hopital Civil | Strasbourg | France |
| COMPLETED |
|
| NOT COMPLETED |
|
|
This analysis population included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Reltecimod 0.5 mg/kg | Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) |
| BG001 | Placebo | Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Disease Category | Count of Participants | Participants |
| ||||||||||||||||
| Comorbidities | Count of Participants | Participants |
| ||||||||||||||||
| Modified Sequential Organ Failure Assessment (mSOFA) Score | 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. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Acute Physiology and Chronic Health Evaluation (APACHE) Score | The Acute Physiology and Chronic Health Evaluation (APACHE) Score is a severity of illness classification system. It is determined within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements (physiologic variables, age, chronic health status). Higher scores correspond to more severe disease and a greater risk of death. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Sepsis Presentation | Count of Participants | Participants |
| ||||||||||||||||
| Acute Kidney Injury (AKI) Presentation | Count of Participants | Participants |
| ||||||||||||||||
| Acuity of AKI | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Durable Loss of Renal Function at Day 28 | 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). | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed necrotizing soft tissue infection (NSTI) and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | 28 Days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Serious Adverse Events (SAEs) | Number of patients experiencing at least one SAE | This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | 28 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Adverse Events (AEs) | The number of patients experiencing at least one AE. | This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | 28 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Freedom From Durable Loss of Renal Function at Day 14 | 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). | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | 14 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intensive Care Unit (ICU)-Free Days | ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28. | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Posted | Median | Full Range | days | 28 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventilator-free Days | Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28. | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Posted | Median | Full Range | days | 28 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vasopressor-free Days | Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28. | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Posted | Median | Full Range | days | 28 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospital Days | Hospital days refers to the number of days a patient spent time in the hospital. | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Posted | Median | Full Range | days | 90 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Number of Deaths | The number of deaths occurring through Day 90 | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | 90 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Secondary Infections | Number of patients experiencing at least one secondary infection | This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | 28 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category | 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. | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | Posted | Median | Full Range | days | 28 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventilator-free Days by Day 14 mSOFA Category | The number of days a patient was not on a ventilator through Day 28, by mSOFA category | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | Posted | Median | Full Range | days | 28 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vasopressor-free Days by Day 14 mSOFA Category | The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | Posted | Median | Full Range | days | 28 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospital Days by Day 14 mSOFA Category | The number of days a patient was in the hospital. | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis. | Posted | Median | Full Range | days | 90 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospital Discharge Location by Day 14 mSOFA Category | 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. | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients alive at Day 14 with available data are included in the analysis. | Posted | Count of Participants | Participants | 90 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cumulative Mortality by Day 14 mSOFA Category | Percentage of patients who died through Day 90 using life table analysis | This analysis population (modified intent-to-treat [mITT]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with a screening mSOFA >= 3 are included in the analysis. | Posted | Number | percentage of patients | 90 Days |
|
|
Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing).
Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reltecimod 0.5 mg/kg | Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) | 5 | 28 | 12 | 28 | 7 | 28 |
| EG001 | Placebo | Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema) | 6 | 30 | 13 | 30 | 8 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Intestinal ischemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intra-abdominal fluid collection | Gastrointestinal disorders | Systematic Assessment |
| ||
| Organ failure | General disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal wall infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia escherichia | Infections and infestations | Systematic Assessment |
| ||
| Postoperative wound infection | Infections and infestations | Systematic Assessment |
| ||
| Retroperitoneal abscess | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Chemical peritonitis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastrointestinal anastomotic complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Urethral injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
| ||
| Device occlusion | Product Issues | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wayne M Dankner, MD, Chief Medical Officer | Atox Bio, Ltd. | 1-919-219-6377 | wayned@atoxbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2020 | Aug 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D010538 | Peritonitis |
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000597133 | AB103 |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Necrotizing Soft Tissue Infection (NSTI) |
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| Cardiovascular Disease |
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| Smoker |
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| Alcohol Abuse |
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| Respiratory Organ Failure |
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| Stage 3 AKI |
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| AKI diagnosed during the 48h following diagnosis of infection |
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