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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Kidney Injury
Peritonitis
Necrotizing Soft Tissue Infection
Interventions Drug: Reltecimod 0.5 mg/kg
Drug: Placebo
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Period Title: Overall Study
Started 28 30
Completed 21 22
Not Completed 7 8
Reason Not Completed
Death             5             6
Discontinuation (includes missing from Day 29)             2             2
Arm/Group Title Reltecimod 0.5 mg/kg Placebo Total
Hide Arm/Group Description Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema) Total of all reporting groups
Overall Number of Baseline Participants 28 30 58
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 30 participants 58 participants
61.7  (14.6) 61.8  (13.6) 61.7  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Female
16
  57.1%
15
  50.0%
31
  53.4%
Male
12
  42.9%
15
  50.0%
27
  46.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Hispanic or Latino
2
   7.1%
0
   0.0%
2
   3.4%
Not Hispanic or Latino
23
  82.1%
29
  96.7%
52
  89.7%
Unknown or Not Reported
3
  10.7%
1
   3.3%
4
   6.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.6%
4
  13.3%
5
   8.6%
White
23
  82.1%
22
  73.3%
45
  77.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  14.3%
4
  13.3%
8
  13.8%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 28 participants 30 participants 58 participants
30.5  (6.9) 32.3  (12.2) 31.4  (9.9)
Disease Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Abdominal Infection
27
  96.4%
29
  96.7%
56
  96.6%
Necrotizing Soft Tissue Infection (NSTI)
1
   3.6%
1
   3.3%
2
   3.4%
Comorbidities  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 28 participants 30 participants 58 participants
Diabetes
11
  39.3%
6
  20.0%
17
  29.3%
Cardiovascular Disease
7
  25.0%
6
  20.0%
13
  22.4%
Smoker
1
   3.6%
5
  16.7%
6
  10.3%
Alcohol Abuse
1
   3.6%
2
   6.7%
3
   5.2%
Modified Sequential Organ Failure Assessment (mSOFA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 28 participants 30 participants 58 participants
4.9  (2.3) 5.4  (3.1) 5.1  (2.8)
[1]
Measure Description: 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.
Acute Physiology and Chronic Health Evaluation (APACHE) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 28 participants 30 participants 58 participants
17.1  (8.5) 16.4  (7.9) 16.7  (8.2)
[1]
Measure Description:

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.
Sepsis Presentation  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 28 participants 30 participants 58 participants
Cardiovascular Organ Failure
12
  42.9%
17
  56.7%
29
  50.0%
Respiratory Organ Failure
2
   7.1%
3
  10.0%
5
   8.6%
Acute Kidney Injury (AKI) Presentation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Stage 2 AKI
20
  71.4%
25
  83.3%
45
  77.6%
Stage 3 AKI
8
  28.6%
5
  16.7%
13
  22.4%
Acuity of AKI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
AKI diagnosed at time of diagnosis of infection
17
  60.7%
12
  40.0%
29
  50.0%
AKI diagnosed during the 48h following diagnosis of infection
11
  39.3%
18
  60.0%
29
  50.0%
1.Primary Outcome
Title Freedom From Durable Loss of Renal Function at Day 28
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
20
  71.4%
23
  76.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reltecimod 0.5 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.649
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Serious Adverse Events (SAEs)
Hide Description Number of patients experiencing at least one SAE
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
12
  42.9%
13
  43.3%
3.Primary Outcome
Title Adverse Events (AEs)
Hide Description The number of patients experiencing at least one AE.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
15
  53.6%
24
  80.0%
4.Secondary Outcome
Title Freedom From Durable Loss of Renal Function at Day 14
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
20
  71.4%
22
  73.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reltecimod 0.5 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Intensive Care Unit (ICU)-Free Days
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Median (Full Range)
Unit of Measure: days
24.0
(0 to 28)
21.0
(0 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reltecimod 0.5 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.420
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Ventilator-free Days
Hide Description Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Median (Full Range)
Unit of Measure: days
26.5
(0 to 28)
26.0
(0 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reltecimod 0.5 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Vasopressor-free Days
Hide Description Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Median (Full Range)
Unit of Measure: days
27.5
(0 to 28)
26.5
(0 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reltecimod 0.5 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.579
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Hospital Days
Hide Description Hospital days refers to the number of days a patient spent time in the hospital.
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Median (Full Range)
Unit of Measure: days
9.0
(2 to 61)
13.0
(1 to 60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reltecimod 0.5 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Cumulative Number of Deaths
Hide Description The number of deaths occurring through Day 90
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
5
  17.9%
6
  20.0%
10.Secondary Outcome
Title Secondary Infections
Hide Description Number of patients experiencing at least one secondary infection
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description:
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)
Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
4
  14.3%
10
  33.3%
11.Secondary Outcome
Title ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Day 14 mSOFA <= 1 Day 14 mSOFA >= 2
Hide Arm/Group Description:
mSOFA total score on Day 14 of 0 or 1
mSOFA total score on Day 14 of at least 2
Overall Number of Participants Analyzed 26 10
Median (Full Range)
Unit of Measure: days
24.0
(5 to 28)
4.0
(0 to 26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 14 mSOFA <= 1, Day 14 mSOFA >= 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Ventilator-free Days by Day 14 mSOFA Category
Hide Description The number of days a patient was not on a ventilator through Day 28, by mSOFA category
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Day 14 mSOFA <= 1 Day 14 mSOFA >= 2
Hide Arm/Group Description:
mSOFA total score on Day 14 of 0 or 1
mSOFA total score on Day 14 of at least 2
Overall Number of Participants Analyzed 26 10
Median (Full Range)
Unit of Measure: days
27.0
(8 to 28)
17.0
(1 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 14 mSOFA <= 1, Day 14 mSOFA >= 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Vasopressor-free Days by Day 14 mSOFA Category
Hide Description The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Day 14 mSOFA <= 1 Day 14 mSOFA >= 2
Hide Arm/Group Description:
mSOFA total score on Day 14 of 0 or 1
mSOFA total score on Day 14 of at least 2
Overall Number of Participants Analyzed 26 10
Median (Full Range)
Unit of Measure: days
28.0
(24 to 28)
18.0
(0 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 14 mSOFA <= 1, Day 14 mSOFA >= 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Hospital Days by Day 14 mSOFA Category
Hide Description The number of days a patient was in the hospital.
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Day 14 mSOFA <= 1 Day 14 mSOFA >= 2
Hide Arm/Group Description:
mSOFA total score on Day 14 of 0 or 1
mSOFA total score on Day 14 of at least 2
Overall Number of Participants Analyzed 26 10
Median (Full Range)
Unit of Measure: days
13.0
(4 to 48)
23.5
(9 to 61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 14 mSOFA <= 1, Day 14 mSOFA >= 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Secondary Outcome
Title Hospital Discharge Location by Day 14 mSOFA Category
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Day 14 mSOFA <= 1 Day 14 mSOFA >= 2
Hide Arm/Group Description:
mSOFA total score on Day 14 of 0 or 1
mSOFA total score on Day 14 of at least 2
Overall Number of Participants Analyzed 38 12
Measure Type: Count of Participants
Unit of Measure: Participants
More Favorable Discharge Location
28
  73.7%
4
  33.3%
Less Favorable Discharge Location
10
  26.3%
8
  66.7%
16.Other Pre-specified Outcome
Title Cumulative Mortality by Day 14 mSOFA Category
Hide Description Percentage of patients who died through Day 90 using life table analysis
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Day 14 mSOFA <= 1 Day 14 mSOFA >= 2
Hide Arm/Group Description:
mSOFA total score on Day 14 of 0 or 1
mSOFA total score on Day 14 of at least 2
Overall Number of Participants Analyzed 26 10
Measure Type: Number
Unit of Measure: percentage of patients
0 31.4
Time Frame Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing).
Adverse Event Reporting Description 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.
 
Arm/Group Title Reltecimod 0.5 mg/kg Placebo
Hide Arm/Group Description Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
All-Cause Mortality
Reltecimod 0.5 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/28 (17.86%)      6/30 (20.00%)    
Hide Serious Adverse Events
Reltecimod 0.5 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/28 (42.86%)      13/30 (43.33%)    
Blood and lymphatic system disorders     
Anemia †  0/28 (0.00%)  0 1/30 (3.33%)  1
Leukocytosis †  0/28 (0.00%)  0 1/30 (3.33%)  1
Cardiac disorders     
Atrial fibrillation †  1/28 (3.57%)  1 0/30 (0.00%)  0
Atrial flutter †  1/28 (3.57%)  1 0/30 (0.00%)  0
Gastrointestinal disorders     
Intestinal ischemia †  0/28 (0.00%)  0 1/30 (3.33%)  1
Intra-abdominal fluid collection †  1/28 (3.57%)  1 0/30 (0.00%)  0
General disorders     
Organ failure †  0/28 (0.00%)  0 1/30 (3.33%)  1
Hepatobiliary disorders     
Hepatic failure †  0/28 (0.00%)  0 1/30 (3.33%)  1
Infections and infestations     
Abdominal wall infection †  0/28 (0.00%)  0 1/30 (3.33%)  1
Pneumonia †  0/28 (0.00%)  0 1/30 (3.33%)  1
Pneumonia escherichia †  1/28 (3.57%)  1 0/30 (0.00%)  0
Postoperative wound infection †  1/28 (3.57%)  1 0/30 (0.00%)  0
Retroperitoneal abscess †  0/28 (0.00%)  0 1/30 (3.33%)  1
Sepsis †  2/28 (7.14%)  2 0/30 (0.00%)  0
Septic shock †  2/28 (7.14%)  2 0/30 (0.00%)  0
Injury, poisoning and procedural complications     
Chemical peritonitis †  0/28 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal anastomotic complication †  1/28 (3.57%)  1 1/30 (3.33%)  1
Gastrointestinal anastomotic leak †  0/28 (0.00%)  0 1/30 (3.33%)  1
Urethral injury †  1/28 (3.57%)  1 0/30 (0.00%)  0
Metabolism and nutrition disorders     
Fluid overload †  1/28 (3.57%)  1 0/30 (0.00%)  0
Hyperkalemia †  0/28 (0.00%)  0 1/30 (3.33%)  1
Nervous system disorders     
Cerebral infarction †  0/28 (0.00%)  0 1/30 (3.33%)  2
Product Issues     
Device occlusion †  1/28 (3.57%)  1 0/30 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury †  1/28 (3.57%)  1 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary edema †  0/28 (0.00%)  0 1/30 (3.33%)  1
Chronic obstructive pulmonary disease †  1/28 (3.57%)  1 0/30 (0.00%)  0
Respiratory failure †  2/28 (7.14%)  2 2/30 (6.67%)  2
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reltecimod 0.5 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/28 (25.00%)      8/30 (26.67%)    
Blood and lymphatic system disorders     
Thrombocytosis †  0/28 (0.00%)  0 2/30 (6.67%)  2
Infections and infestations     
Pneumonia †  0/28 (0.00%)  0 3/30 (10.00%)  3
Sepsis †  2/28 (7.14%)  2 0/30 (0.00%)  0
Septic shock †  2/28 (7.14%)  2 0/30 (0.00%)  0
Metabolism and nutrition disorders     
Fluid overload †  2/28 (7.14%)  2 0/30 (0.00%)  0
Psychiatric disorders     
Delirium †  0/28 (0.00%)  0 2/30 (6.67%)  2
Respiratory, thoracic and mediastinal disorders     
Pleural effusion †  0/28 (0.00%)  0 2/30 (6.67%)  2
Respiratory failure †  2/28 (7.14%)  2 2/30 (6.67%)  2
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wayne M Dankner, MD, Chief Medical Officer
Organization: Atox Bio, Ltd.
Phone: 1-919-219-6377
EMail: wayned@atoxbio.com
Layout table for additonal information
Responsible Party: Atox Bio Ltd
ClinicalTrials.gov Identifier: NCT03403751    
Other Study ID Numbers: ATB-203
First Submitted: January 6, 2018
First Posted: January 19, 2018
Results First Submitted: August 18, 2021
Results First Posted: September 16, 2021
Last Update Posted: October 12, 2021