Study Stopped
Very slow enrollment of target patient population
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
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)
1 other identifier
interventional
58
2 countries
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2018
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2018
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedStudy Start
First participant enrolled
May 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2019
CompletedResults Posted
Study results publicly available
September 16, 2021
CompletedOctober 12, 2021
September 1, 2021
1.6 years
January 6, 2018
August 18, 2021
September 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
28 Days
Serious Adverse Events (SAEs)
Number of patients experiencing at least one SAE
28 Days
Adverse Events (AEs)
The number of patients experiencing at least one AE.
28 Days
Secondary Outcomes (12)
Freedom From Durable Loss of Renal Function at Day 14
14 Days
Intensive Care Unit (ICU)-Free Days
28 Days
Ventilator-free Days
28 Days
Vasopressor-free Days
28 Days
Hospital Days
90 Days
- +7 more secondary outcomes
Other Outcomes (1)
Cumulative Mortality by Day 14 mSOFA Category
90 Days
Study Arms (2)
Reltecimod 0.5 mg/kg
EXPERIMENTALSingle IV infusion of Reltecimod 0.5 mg/kg
Placebo
PLACEBO COMPARATORSingle IV infusion of 0.9% Sodium Chloride Injection (Normal Saline)
Interventions
Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes
Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atox Bio Ltdlead
Study Sites (56)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Banner University Medical Center
Tucson, Arizona, 24857, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
UCSD Medical Center
San Diego, California, 92103, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
UCH-Memorial Health System
Colorado Springs, Colorado, 80909, United States
University of Colorado Hospital
Denver, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
UF Health Shands Hospital
Gainesville, Florida, 32610, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
LSU Health Science Center
New Orleans, Louisiana, 70012, United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455, United States
University of Missouri
Columbia, Missouri, 65211, United States
Capital Health System, Inc.
Trenton, New Jersey, 98638, United States
Erie County Medical Center-Affliate of SUNYat Buffalo
Buffalo, New York, 14215, United States
Carolinas Medical Center
Charlotte, North Carolina, 28208, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, 45219, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Trauma Center at PENN
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MUSC
Charleston, South Carolina, 29425, United States
John Peter Smith Health Network
Fort Worth, Texas, 76104, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Hopital Victor Dupouy
Argenteuil, France
CHRU la Cavale Blanche
Brest, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CHU Dijon
Dijon, France
CHD Vendee
La Roche-sur-Yon, France
CH Le Mans
Le Mans, France
Robert Salengro Hopital-CHRU Lille
Lille, France
CHU de Limoges
Limoges, France
CHU Lyon Sud
Lyon, France
Hopital Edouard Herriot
Lyon, France
Hopital Saint Eloi
Montpellier, France
CHU de Nante Hotel-Dieu
Nantes, France
CHU Nimes
Nîmes, France
Hopital Cochin
Paris, France
CHU Rennes
Rennes, France
Nouvel Hopital Civil
Strasbourg, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wayne M Dankner, MD, Chief Medical Officer
- Organization
- Atox Bio, Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Azra Bihorac, MD
University of Florida Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor personnel and clinical research associates (CRAs) will also be blinded to study treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2018
First Posted
January 19, 2018
Study Start
May 24, 2018
Primary Completion
December 14, 2019
Study Completion
December 14, 2019
Last Updated
October 12, 2021
Results First Posted
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share