Acute Kidney InjuryPhase 3NCT03403751
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
A Phase 3 study testing Reltecimod 0.5 mg/kg in people with Acute Kidney Injury and Peritonitis, run by Atox Bio Ltd at 56 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- What is being tested?
- Reltecimod 0.5 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 56 sitesin 2 countries
- Study dates
- 24 May 2018to 14 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- 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
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
United States40 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Maryland, Baltimore
Baltimore, Maryland, 21201
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Erie County Medical Center-Affliate of SUNYat Buffalo
Buffalo, New York, 14215
MUSC
Charleston, South Carolina, 29425
Carolinas Medical Center
Charlotte, North Carolina, 28208
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, 45219
UCH-Memorial Health System
Colorado Springs, Colorado, 80909
University of Missouri
Columbia, Missouri, 65211
The Ohio State University
Columbus, Ohio, 43210
University of Colorado Hospital
Denver, Colorado, 80045
Henry Ford Health System
Detroit, Michigan, 48202
Fairview Southdale Hospital
Edina, Minnesota, 55435
John Peter Smith Health Network
Fort Worth, Texas, 76104
UF Health Shands Hospital
Gainesville, Florida, 32610
East Carolina University
Greenville, North Carolina, 27834
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
University of Kentucky
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Loma Linda University Medical Center
Loma Linda, California, 92354
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455
Yale New Haven Hospital
New Haven, Connecticut, 06520
LSU Health Science Center
New Orleans, Louisiana, 70012
The Trauma Center at PENN
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Maricopa Medical Center
Phoenix, Arizona, 85008
Oregon Health and Science University
Portland, Oregon, 97239
University of California, Davis Medical Center
Sacramento, California, 95817
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
UCSD Medical Center
San Diego, California, 92103
Harborview Medical Center
Seattle, Washington, 98104
University of Washington Medical Center
Seattle, Washington, 98195
Harbor-UCLA Medical Center
Torrance, California, 90502
Capital Health System, Inc.
Trenton, New Jersey, 98638
Banner University Medical Center
Tucson, Arizona, 24857
Washington Hospital Center
Washington D.C., District of Columbia, 20010
France16 sites
Hopital Victor Dupouy
Argenteuil
CHRU la Cavale Blanche
Brest
CHU Clermont-Ferrand
Clermont-Ferrand
CHU Dijon
Dijon
CHD Vendee
La Roche-sur-Yon
CH Le Mans
Le Mans
Robert Salengro Hopital-CHRU Lille
Lille
CHU de Limoges
Limoges
CHU Lyon Sud
Lyon
Hopital Edouard Herriot
Lyon
Hopital Saint Eloi
Montpellier
CHU de Nante Hotel-Dieu
Nantes
CHU Nimes
Nîmes
Hopital Cochin
Paris
CHU Rennes
Rennes
Nouvel Hopital Civil
Strasbourg
About this study
Official title: Phase 3 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)
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.
Read the 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.
- Being tested
- Reltecimod 0.5 mg/kg, Placebo
- Keywords
- Abdominal sepsis, AKI, NSTI
- Medical subject headings
- Acute Kidney Injury, Peritonitis, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reltecimod 0.5 mg/kgDrug
Also called AB103 0.5 mg/kg
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes
PlaceboDrug
Also called 0.9% Sodium Chloride Injection (Normal saline)
Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Reltecimod 0.5 mg/kg | Experimental | Single IV infusion of Reltecimod 0.5 mg/kg Receives: Drug: Reltecimod 0.5 mg/kg |
| Placebo | Placebo comparator | Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 Days
Serious Adverse Events (SAEs)
Number of patients experiencing at least one SAE
Measured: 28 Days
Adverse Events (AEs)
The number of patients experiencing at least one AE.
Measured: 28 Days
Secondary outcomes (12)
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).
Measured: 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.
Measured: 28 Days
Ventilator-free Days
Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
Measured: 28 Days
Vasopressor-free Days
Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
Measured: 28 Days
Hospital Days
Hospital days refers to the number of days a patient spent time in the hospital.
Measured: 90 Days
Cumulative Number of Deaths
The number of deaths occurring through Day 90
Measured: 90 Days
Secondary Infections
Number of patients experiencing at least one secondary infection
Measured: 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.
Measured: 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
Measured: 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
Measured: 28 Days
Hospital Days by Day 14 mSOFA Category
The number of days a patient was in the hospital.
Measured: 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.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start24 May 2018
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Why it stopped: Very slow enrollment of target patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization of study drug (Reltecimod) and placebo (normal saline)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atox Bio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Azra Bihorac, MD, Principal investigator, University of Florida Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403751
- Sponsor's protocol ID
- ATB-203
- Status last verified
- Sep 2021
- First submitted
- 6 Jan 2018
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)
- ClinicalTrials.gov ID
- NCT03403751
- Acronym / sponsor ID
- ATB-203
- Keywords
- Abdominal sepsis, AKI, NSTI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very slow enrollment of target patient population
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Atox Bio LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2018 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization of study drug (Reltecimod) and placebo (normal saline)
| Arm | Type | Receives |
|---|---|---|
| Reltecimod 0.5 mg/kg | Experimental | Drug: Reltecimod 0.5 mg/kgSingle IV infusion of Reltecimod 0.5 mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboSingle IV infusion of 0.9% Sodium Chloride Injection (Normal Saline) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (18 listed)
- Has known prior history of chronic kidney disease (CKD( with a documented estimated GFR (eGFR) < 30 mL/min
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reltecimod 0.5 mg/kgAlso: AB103 0.5 mg/kgSingle IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes | Drug | Reltecimod 0.5 mg/kg |
| PlaceboAlso: 0.9% Sodium Chloride Injection (Normal saline)Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes | Drug | Placebo |
Primary outcome
Freedom From Durable Loss of Renal Function at Day 28
Time frame: 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)
Time frame: 28 Days
Number of patients experiencing at least one SAE
Adverse Events (AEs)
Time frame: 28 Days
The number of patients experiencing at least one AE.
12 secondary outcomes
Freedom From Durable Loss of Renal Function at Day 14
Time frame: 14 Days
Intensive Care Unit (ICU)-Free Days
Time frame: 28 Days
Ventilator-free Days
Time frame: 28 Days
Vasopressor-free Days
Time frame: 28 Days
Hospital Days
Time frame: 90 Days
Cumulative Number of Deaths
Time frame: 90 Days
Secondary Infections
Time frame: 28 Days
ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category
Time frame: 28 Days
Ventilator-free Days by Day 14 mSOFA Category
Time frame: 28 Days
Vasopressor-free Days by Day 14 mSOFA Category
Time frame: 28 Days
Hospital Days by Day 14 mSOFA Category
Time frame: 90 Days
Hospital Discharge Location by Day 14 mSOFA Category
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azra Bihorac, MD principal investigator
University of Florida Health
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reltecimod 0.5 mg/kg in people with Acute Kidney Injury and Peritonitis, run by Atox Bio Ltd at 56 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Durable Loss of Renal Function at Day 28 (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.