- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403751
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Argenteuil, France
- Hôpital Victor Dupouy
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Brest, France
- CHRU La Cavale Blanche
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Clermont-Ferrand, France
- Chu Clermont-Ferrand
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Dijon, France
- CHU Dijon
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La Roche-sur-Yon, France
- CHD Vendee
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Le Mans, France
- CH Le Mans
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Lille, France
- Robert Salengro Hopital-CHRU Lille
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Limoges, France
- Chu de Limoges
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Lyon, France
- Hôpital Edouard Herriot
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Lyon, France
- CHU Lyon Sud
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Montpellier, France
- Hopital Saint Eloi
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Nantes, France
- CHU de Nante Hotel-Dieu
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Nîmes, France
- CHU Nîmes
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Paris, France
- Hôpital Cochin
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Rennes, France
- CHU Rennes
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Strasbourg, France
- Nouvel Hopital Civil
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Arizona
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Phoenix, Arizona, United States, 85008
- Maricopa Medical Center
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Tucson, Arizona, United States, 24857
- Banner University Medical Center
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Sacramento, California, United States, 95817
- University of California, Davis Medical Center
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San Diego, California, United States, 92103
- UCSD Medical Center
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Torrance, California, United States, 90502
- Harbor-UCLA Medical Center
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Colorado
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Colorado Springs, Colorado, United States, 80909
- UCH-Memorial Health System
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Denver, Colorado, United States, 80045
- University of Colorado Hospital
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale New Haven Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Florida
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Gainesville, Florida, United States, 32610
- UF Health Shands Hospital
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospital and Clinics
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Kentucky
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Lexington, Kentucky, United States, 40536
- University Of Kentucky
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Louisiana
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New Orleans, Louisiana, United States, 70012
- LSU Health Science Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland, Baltimore
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Minnesota
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center-Fairview
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Missouri
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Columbia, Missouri, United States, 65211
- University of Missouri
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New Jersey
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Trenton, New Jersey, United States, 98638
- Capital Health System, Inc.
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New York
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Buffalo, New York, United States, 14215
- Erie County Medical Center-Affliate of SUNYat Buffalo
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North Carolina
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Charlotte, North Carolina, United States, 28208
- Carolinas Medical Center
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Greenville, North Carolina, United States, 27834
- East Carolina University
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati Medical Center (UCMC)
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- St. Luke's University Health network
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Hershey, Pennsylvania, United States, 17033
- The Pennsylvania State University and the Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, United States, 19104
- The Trauma Center at PENN
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South Carolina
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Charleston, South Carolina, United States, 29425
- MUSC
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Texas
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Fort Worth, Texas, United States, 76104
- John Peter Smith Health Network
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reltecimod 0.5 mg/kg
Single IV infusion of Reltecimod 0.5 mg/kg
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Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes
Other Names:
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Placebo Comparator: Placebo
Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline)
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Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom From Durable Loss of Renal Function at Day 28
Time Frame: 28 Days
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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).
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28 Days
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Serious Adverse Events (SAEs)
Time Frame: 28 Days
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Number of patients experiencing at least one SAE
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28 Days
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Adverse Events (AEs)
Time Frame: 28 Days
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The number of patients experiencing at least one AE.
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28 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom From Durable Loss of Renal Function at Day 14
Time Frame: 14 Days
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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).
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14 Days
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Intensive Care Unit (ICU)-Free Days
Time Frame: 28 Days
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ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.
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28 Days
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Ventilator-free Days
Time Frame: 28 Days
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Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.
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28 Days
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Vasopressor-free Days
Time Frame: 28 Days
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Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.
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28 Days
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Hospital Days
Time Frame: 90 Days
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Hospital days refers to the number of days a patient spent time in the hospital.
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90 Days
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Cumulative Number of Deaths
Time Frame: 90 Days
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The number of deaths occurring through Day 90
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90 Days
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Secondary Infections
Time Frame: 28 Days
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Number of patients experiencing at least one secondary infection
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28 Days
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ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category
Time Frame: 28 Days
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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.
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28 Days
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Ventilator-free Days by Day 14 mSOFA Category
Time Frame: 28 Days
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The number of days a patient was not on a ventilator through Day 28, by mSOFA category
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28 Days
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Vasopressor-free Days by Day 14 mSOFA Category
Time Frame: 28 Days
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The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category
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28 Days
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Hospital Days by Day 14 mSOFA Category
Time Frame: 90 Days
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The number of days a patient was in the hospital.
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90 Days
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Hospital Discharge Location by Day 14 mSOFA Category
Time Frame: 90 Days
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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.
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90 Days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Mortality by Day 14 mSOFA Category
Time Frame: 90 Days
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Percentage of patients who died through Day 90 using life table analysis
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90 Days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Azra Bihorac, MD, University of Florida Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATB-203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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