Trial · NCT03403751

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

NCT03403751, Phase 3, Terminated, Atox Bio Ltd; results first posted 2021-09-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury. Trials, record NCT03403751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03403751

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
NCT number: NCT03403751
Status: Terminated
Phases: Phase 3
Enrollment: 58 participants, actual
Lead sponsor: Atox Bio Ltd
Conditions: Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
Interventions: Reltecimod 0.5 mg/kg, Placebo
First posted: 2018-01-19
Last updated: 2021-10-12
Results first posted: 2021-09-16

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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).
Primary	Serious Adverse Events (SAEs)	28 Days	Number of patients experiencing at least one SAE
Primary	Adverse Events (AEs)	28 Days	The number of patients experiencing at least one AE.
Secondary	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).
Secondary	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.
Secondary	Ventilator-free Days	28 Days	Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
Secondary	Vasopressor-free Days	28 Days	Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
Secondary	Hospital Days	90 Days	Hospital days refers to the number of days a patient spent time in the hospital.
Secondary	Cumulative Number of Deaths	90 Days	The number of deaths occurring through Day 90
Secondary	Secondary Infections	28 Days	Number of patients experiencing at least one secondary infection

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Freedom From Durable Loss of Renal Function at Day 28	28 Days	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.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Serious Adverse Events (SAEs)	28 Days	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.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Adverse Events (AEs)	28 Days	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Freedom From Durable Loss of Renal Function at Day 14	14 Days	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Intensive Care Unit (ICU)-Free Days	28 Days	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.	days	MEDIAN
SECONDARY	Ventilator-free Days	28 Days	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.	days	MEDIAN
SECONDARY	Vasopressor-free Days	28 Days	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.	days	MEDIAN
SECONDARY	Hospital Days	90 Days	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.	days	MEDIAN
SECONDARY	Cumulative Number of Deaths	90 Days	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Secondary Infections	28 Days	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.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Freedom From Durable Loss of Renal Function at Day 28	Reltecimod 0.5 mg/kg	20		Participants
Freedom From Durable Loss of Renal Function at Day 28	Placebo	23		Participants
Serious Adverse Events (SAEs)	Reltecimod 0.5 mg/kg	12		Participants
Serious Adverse Events (SAEs)	Placebo	13		Participants
Adverse Events (AEs)	Reltecimod 0.5 mg/kg	15		Participants
Adverse Events (AEs)	Placebo	24		Participants
Freedom From Durable Loss of Renal Function at Day 14	Reltecimod 0.5 mg/kg	20		Participants
Freedom From Durable Loss of Renal Function at Day 14	Placebo	22		Participants
Intensive Care Unit (ICU)-Free Days	Reltecimod 0.5 mg/kg	24.0	Full Range 0 to 28	days
Intensive Care Unit (ICU)-Free Days	Placebo	21.0	Full Range 0 to 28	days

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Reltecimod 0.5 mg/kg	28
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Reltecimod 0.5 mg/kg	21
Overall Study	COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	Reltecimod 0.5 mg/kg	7
Overall Study	NOT COMPLETED	Placebo	8

Source ClinicalTrials.gov

Adverse events70

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Thrombocytosis	Blood and lymphatic system disorders	Reltecimod 0.5 mg/kg	0	28	0
other	Thrombocytosis	Blood and lymphatic system disorders	Placebo	2	30	2
other	Pneumonia	Infections and infestations	Reltecimod 0.5 mg/kg	0	28	0
other	Pneumonia	Infections and infestations	Placebo	3	30	3
other	Sepsis	Infections and infestations	Reltecimod 0.5 mg/kg	2	28	2
other	Sepsis	Infections and infestations	Placebo	0	30	0
other	Septic shock	Infections and infestations	Reltecimod 0.5 mg/kg	2	28	2
other	Septic shock	Infections and infestations	Placebo	0	30	0
other	Fluid overload	Metabolism and nutrition disorders	Reltecimod 0.5 mg/kg	2	28	2
other	Fluid overload	Metabolism and nutrition disorders	Placebo	0	30	0

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Reltecimod 0.5 mg/kg	5	28
Total, all-cause mortality	Placebo	6	30
Total, other adverse events	Reltecimod 0.5 mg/kg	7	28
Total, other adverse events	Placebo	8	30
Total, serious adverse events	Reltecimod 0.5 mg/kg	12	28
Total, serious adverse events	Placebo	13	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Reltecimod 0.5 mg/kg vs Placebo: Adverse Events (AEs)	Trial comparisons
Reltecimod 0.5 mg/kg vs Placebo: Secondary Infections	Trial comparisons
Reltecimod 0.5 mg/kg vs Placebo: Freedom From Durable Loss of Renal Function at Day 14	Trial comparisons
Reltecimod 0.5 mg/kg vs Placebo: Freedom From Durable Loss of Renal Function at Day 28	Trial comparisons
Reltecimod 0.5 mg/kg vs Placebo: Cumulative Number of Deaths	Trial comparisons
Reltecimod 0.5 mg/kg vs Placebo: deaths from any cause	Trial comparisons
Reltecimod 0.5 mg/kg vs Placebo: Serious Adverse Events (SAEs)	Trial comparisons
Reltecimod 0.5 mg/kg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03403751

GET https://conductscience.org/api/trials/v1/NCT03403751/results?page=2

API reference For AI assistants