A Phase 3 interventional study of Reltecimod 0.5 mg/kg and Placebo in Acute Kidney Injury, Peritonitis and Necrotizing Soft Tissue Infection, sponsored by Atox Bio Ltd. Terminated at 56 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Atox Bio Ltd · Phase 3, Interventional, and Treatment
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's enrollment of 58 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Atox Bio Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (eGFR) \< 30 mL/min
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single IV infusion of Reltecimod 0.5 mg/kg
Drug: Reltecimod 0.5 mg/kg
Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline)
Drug: Placebo
Drug page: AB103
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes
Also known as: AB103 0.5 mg/kg
Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
Also known as: 0.9% Sodium Chloride Injection (Normal saline)
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
Serious Adverse Events (SAEs)
Number of patients experiencing at least one SAE
Time frame: 28 Days
Adverse Events (AEs)
The number of patients experiencing at least one AE.
Time frame: 28 Days
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
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
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
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
Hospital Days
Hospital days refers to the number of days a patient spent time in the hospital.
Time frame: 90 Days
Cumulative Number of Deaths
The number of deaths occurring through Day 90
Time frame: 90 Days
Secondary Infections
Number of patients experiencing at least one secondary infection
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 28 Days
Hospital Days by Day 14 mSOFA Category
The number of days a patient was in the hospital.
Time frame: 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.
Time frame: 90 Days
Cumulative Mortality by Day 14 mSOFA Category
Percentage of patients who died through Day 90 using life table analysis
Time frame: 90 Days
| Milestone | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Started | 28 | 30 |
| Completed | 21 | 22 |
| Not completed | 7 | 8 |
| Withdrew: Death | 5 | 6 |
| Withdrew: Discontinuation (includes missing from day 29) | 2 | 2 |
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).
| Participants | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Freedom From Durable Loss of Renal Function at Day 28 | 20 | 23 |
Number of patients experiencing at least one SAE
| Participants | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Serious Adverse Events (SAEs) | 12 | 13 |
The number of patients experiencing at least one AE.
| Participants | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Adverse Events (AEs) | 15 | 24 |
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).
| Participants | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Freedom From Durable Loss of Renal Function at Day 14 | 20 | 22 |
ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.
| days | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Intensive Care Unit (ICU)-Free Days | 24.0 (0 to 28) | 21.0 (0 to 28) |
Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
| days | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Ventilator-free Days | 26.5 (0 to 28) | 26.0 (0 to 28) |
Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
| days | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Vasopressor-free Days | 27.5 (0 to 28) | 26.5 (0 to 28) |
Hospital days refers to the number of days a patient spent time in the hospital.
| days | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Hospital Days | 9.0 (2 to 61) | 13.0 (1 to 60) |
The number of deaths occurring through Day 90
| Participants | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Cumulative Number of Deaths | 5 | 6 |
Number of patients experiencing at least one secondary infection
| Participants | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| Secondary Infections | 4 | 10 |
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.
| days | Day 14 mSOFA <= 1 | Day 14 mSOFA >= 2 |
|---|---|---|
| ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category | 24.0 (5 to 28) | 4.0 (0 to 26) |
The number of days a patient was not on a ventilator through Day 28, by mSOFA category
| days | Day 14 mSOFA <= 1 | Day 14 mSOFA >= 2 |
|---|---|---|
| Ventilator-free Days by Day 14 mSOFA Category | 27.0 (8 to 28) | 17.0 (1 to 28) |
The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category
| days | Day 14 mSOFA <= 1 | Day 14 mSOFA >= 2 |
|---|---|---|
| Vasopressor-free Days by Day 14 mSOFA Category | 28.0 (24 to 28) | 18.0 (0 to 28) |
The number of days a patient was in the hospital.
| days | Day 14 mSOFA <= 1 | Day 14 mSOFA >= 2 |
|---|---|---|
| Hospital Days by Day 14 mSOFA Category | 13.0 (4 to 48) | 23.5 (9 to 61) |
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.
| Participants | Day 14 mSOFA <= 1 | Day 14 mSOFA >= 2 |
|---|---|---|
| More Favorable Discharge Location | 28 | 4 |
| Less Favorable Discharge Location | 10 | 8 |
Percentage of patients who died through Day 90 using life table analysis
| percentage of patients | Day 14 mSOFA <= 1 | Day 14 mSOFA >= 2 |
|---|---|---|
| Cumulative Mortality by Day 14 mSOFA Category | 0 | 31.4 |
Collected over Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reltecimod 0.5 mg/kg | 5/28 (17.9%) | 12/28 (42.9%) | 7/28 (25%) |
| Placebo | 6/30 (20%) | 13/30 (43.3%) | 8/30 (26.7%) |
| Event | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| SepsisInfections and infestations | 2/28 | 0/30 |
| Septic shockInfections and infestations | 2/28 | 0/30 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/28 | 2/30 |
| Atrial fibrillationCardiac disorders | 1/28 | 0/30 |
| Atrial flutterCardiac disorders | 1/28 | 0/30 |
| Intra-abdominal fluid collectionGastrointestinal disorders | 1/28 | 0/30 |
| Pneumonia escherichiaInfections and infestations | 1/28 | 0/30 |
| Postoperative wound infectionInfections and infestations | 1/28 | 0/30 |
| Gastrointestinal anastomotic complicationInjury, poisoning and procedural complications | 1/28 | 1/30 |
| Urethral injuryInjury, poisoning and procedural complications | 1/28 | 0/30 |
| Event | Reltecimod 0.5 mg/kg | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 0/28 | 3/30 |
| SepsisInfections and infestations | 2/28 | 0/30 |
| Septic shockInfections and infestations | 2/28 | 0/30 |
| Fluid overloadMetabolism and nutrition disorders | 2/28 | 0/30 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/28 | 2/30 |
| ThrombocytosisBlood and lymphatic system disorders | 0/28 | 2/30 |
| DeliriumPsychiatric disorders | 0/28 | 2/30 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/28 | 2/30 |
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(years) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Mean | 61.7 ± 14.6 | 61.8 ± 13.6 | 61.7 ± 14.0 |
| Sex: Female, Male(Participants) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Female | 16 | 15 | 31 |
| Male | 12 | 15 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 23 | 29 | 52 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 23 | 22 | 45 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 4 | 8 |
| Body Mass Index (BMI)(kg/m^2) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Mean | 30.5 ± 6.9 | 32.3 ± 12.2 | 31.4 ± 9.9 |
| Disease Category(Participants) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Abdominal Infection | 27 | 29 | 56 |
| Necrotizing Soft Tissue Infection (NSTI) | 1 | 1 | 2 |
| Comorbidities(Participants) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Diabetes | 11 | 6 | 17 |
| Cardiovascular Disease | 7 | 6 | 13 |
| Smoker | 1 | 5 | 6 |
| Alcohol Abuse | 1 | 2 | 3 |
| Modified Sequential Organ Failure Assessment (mSOFA) Score(score on a scale) | Reltecimod 0.5 mg/kg | Placebo | Total |
|---|---|---|---|
| Mean | 4.9 ± 2.3 | 5.4 ± 3.1 | 5.1 ± 2.8 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AB103
Atox Bio Ltd