Acute Kidney Injury, Necrotizing Soft Tissue Infection, Peritonitis
Conditions
Keywords
Abdominal sepsis, AKI, NSTI
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.
Interventions
DRUGReltecimod 0.5 mg/kg
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes
DRUGPlacebo
Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
Sponsors
Atox Bio Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor personnel and clinical research associates (CRAs) will also be blinded to study treatment.
Intervention model description
1:1 randomization of study drug (Reltecimod) and placebo (normal saline)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | 28 Days | The number of patients experiencing at least one AE. |
| Freedom From Durable Loss of Renal Function at Day 28 | 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). |
| Serious Adverse Events (SAEs) | 28 Days | Number of patients experiencing at least one SAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free Days | 28 Days | Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28. |
| Vasopressor-free Days | 28 Days | Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28. |
| Hospital Days | 90 Days | Hospital days refers to the number of days a patient spent time in the hospital. |
| Cumulative Number of Deaths | 90 Days | The number of deaths occurring through Day 90 |
| Secondary Infections | 28 Days | Number of patients experiencing at least one secondary infection |
| Ventilator-free Days by Day 14 mSOFA Category | 28 Days | The number of days a patient was not on a ventilator through Day 28, by mSOFA category |
| Vasopressor-free Days by Day 14 mSOFA Category | 28 Days | The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category |
| Hospital Days by Day 14 mSOFA Category | 90 Days | The number of days a patient was in the hospital. |
| Hospital Discharge Location by Day 14 mSOFA Category | 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. |
| ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category | 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. |
| Intensive Care Unit (ICU)-Free Days | 28 Days | ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28. |
| Freedom From Durable Loss of Renal Function at Day 14 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Mortality by Day 14 mSOFA Category | 90 Days | Percentage of patients who died through Day 90 using life table analysis |
Countries
France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reltecimod 0.5 mg/kg Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) | 28 |
| Placebo Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema) | 30 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 6 |
| Overall Study | Discontinuation (includes missing from Day 29) | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | Reltecimod 0.5 mg/kg |
|---|---|---|---|
| Acuity of AKI AKI diagnosed at time of diagnosis of infection | 29 Participants | 12 Participants | 17 Participants |
| Acuity of AKI AKI diagnosed during the 48h following diagnosis of infection | 29 Participants | 18 Participants | 11 Participants |
| Acute Kidney Injury (AKI) Presentation Stage 2 AKI | 45 Participants | 25 Participants | 20 Participants |
| Acute Kidney Injury (AKI) Presentation Stage 3 AKI | 13 Participants | 5 Participants | 8 Participants |
| Acute Physiology and Chronic Health Evaluation (APACHE) Score | 16.7 score on a scale STANDARD_DEVIATION 8.2 | 16.4 score on a scale STANDARD_DEVIATION 7.9 | 17.1 score on a scale STANDARD_DEVIATION 8.5 |
| Age, Continuous | 61.7 years STANDARD_DEVIATION 14 | 61.8 years STANDARD_DEVIATION 13.6 | 61.7 years STANDARD_DEVIATION 14.6 |
| Body Mass Index (BMI) | 31.4 kg/m^2 STANDARD_DEVIATION 9.9 | 32.3 kg/m^2 STANDARD_DEVIATION 12.2 | 30.5 kg/m^2 STANDARD_DEVIATION 6.9 |
| Comorbidities Alcohol Abuse | 3 Participants | 2 Participants | 1 Participants |
| Comorbidities Cardiovascular Disease | 13 Participants | 6 Participants | 7 Participants |
| Comorbidities Diabetes | 17 Participants | 6 Participants | 11 Participants |
| Comorbidities Smoker | 6 Participants | 5 Participants | 1 Participants |
| Disease Category Abdominal Infection | 56 Participants | 29 Participants | 27 Participants |
| Disease Category Necrotizing Soft Tissue Infection (NSTI) | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 29 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Modified Sequential Organ Failure Assessment (mSOFA) Score | 5.1 score on a scale STANDARD_DEVIATION 2.8 | 5.4 score on a scale STANDARD_DEVIATION 3.1 | 4.9 score on a scale STANDARD_DEVIATION 2.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 45 Participants | 22 Participants | 23 Participants |
| Sepsis Presentation Cardiovascular Organ Failure | 29 Participants | 17 Participants | 12 Participants |
| Sepsis Presentation Respiratory Organ Failure | 5 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Female | 31 Participants | 15 Participants | 16 Participants |
| Sex: Female, Male Male | 27 Participants | 15 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 28 | 6 / 30 |
| other Total, other adverse events | 7 / 28 | 8 / 30 |
| serious Total, serious adverse events | 12 / 28 | 13 / 30 |
Outcome results
Primary
Adverse Events (AEs)
The number of patients experiencing at least one AE.
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Adverse Events (AEs) | 15 Participants |
| Placebo | Adverse Events (AEs) | 24 Participants |
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).
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Freedom From Durable Loss of Renal Function at Day 28 | 20 Participants |
| Placebo | Freedom From Durable Loss of Renal Function at Day 28 | 23 Participants |
p-value: 0.649Chi-squared
Primary
Serious Adverse Events (SAEs)
Number of patients experiencing at least one SAE
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Serious Adverse Events (SAEs) | 12 Participants |
| Placebo | Serious Adverse Events (SAEs) | 13 Participants |
Secondary
Cumulative Number of Deaths
The number of deaths occurring through Day 90
Time frame: 90 Days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Cumulative Number of Deaths | 5 Participants |
| Placebo | Cumulative Number of Deaths | 6 Participants |
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).
Time frame: 14 Days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Freedom From Durable Loss of Renal Function at Day 14 | 20 Participants |
| Placebo | Freedom From Durable Loss of Renal Function at Day 14 | 22 Participants |
p-value: 0.871Chi-squared
Secondary
Hospital Days
Hospital days refers to the number of days a patient spent time in the hospital.
Time frame: 90 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Hospital Days | 9.0 days |
| Placebo | Hospital Days | 13.0 days |
p-value: 0.227Wilcoxon (Mann-Whitney)
Secondary
Hospital Days by Day 14 mSOFA Category
The number of days a patient was in the hospital.
Time frame: 90 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Hospital Days by Day 14 mSOFA Category | 13.0 days |
| Placebo | Hospital Days by Day 14 mSOFA Category | 23.5 days |
p-value: 0.007Wilcoxon (Mann-Whitney)
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.
Time frame: 90 Days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Reltecimod 0.5 mg/kg | Hospital Discharge Location by Day 14 mSOFA Category | More Favorable Discharge Location | 28 Participants |
| Reltecimod 0.5 mg/kg | Hospital Discharge Location by Day 14 mSOFA Category | Less Favorable Discharge Location | 10 Participants |
| Placebo | Hospital Discharge Location by Day 14 mSOFA Category | More Favorable Discharge Location | 4 Participants |
| Placebo | Hospital Discharge Location by Day 14 mSOFA Category | Less Favorable Discharge Location | 8 Participants |
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.
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category | 24.0 days |
| Placebo | ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category | 4.0 days |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Intensive Care Unit (ICU)-Free Days | 24.0 days |
| Placebo | Intensive Care Unit (ICU)-Free Days | 21.0 days |
p-value: 0.42Wilcoxon (Mann-Whitney)
Secondary
Secondary Infections
Number of patients experiencing at least one secondary infection
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Secondary Infections | 4 Participants |
| Placebo | Secondary Infections | 10 Participants |
Secondary
Vasopressor-free Days
Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Vasopressor-free Days | 27.5 days |
| Placebo | Vasopressor-free Days | 26.5 days |
p-value: 0.579Wilcoxon (Mann-Whitney)
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
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Vasopressor-free Days by Day 14 mSOFA Category | 28.0 days |
| Placebo | Vasopressor-free Days by Day 14 mSOFA Category | 18.0 days |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Ventilator-free Days
Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Ventilator-free Days | 26.5 days |
| Placebo | Ventilator-free Days | 26.0 days |
p-value: 0.448Wilcoxon (Mann-Whitney)
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
Time frame: 28 Days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Ventilator-free Days by Day 14 mSOFA Category | 27.0 days |
| Placebo | Ventilator-free Days by Day 14 mSOFA Category | 17.0 days |
p-value: 0.002Wilcoxon (Mann-Whitney)
Other Pre-specified
Cumulative Mortality by Day 14 mSOFA Category
Percentage of patients who died through Day 90 using life table analysis
Time frame: 90 Days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reltecimod 0.5 mg/kg | Cumulative Mortality by Day 14 mSOFA Category | 0 percentage of patients |
| Placebo | Cumulative Mortality by Day 14 mSOFA Category | 31.4 percentage of patients |