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

NCT ID: NCT03403751

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-24
• Study Completion Date: 2019-12-14

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.

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.

Conditions

Acute Kidney Injury; Peritonitis; Necrotizing Soft Tissue Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reltecimod 0.5 mg/kg

Single IV infusion of Reltecimod 0.5 mg/kg

Group Type: EXPERIMENTAL

Reltecimod 0.5 mg/kg

Intervention Type: DRUG

Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes

Placebo

Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes

Interventions

Reltecimod 0.5 mg/kg

Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes

Intervention Type: DRUG

Placebo

Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes

Intervention Type: DRUG

Other Intervention Names

AB103 0.5 mg/kg; 0.9% Sodium Chloride Injection (Normal saline)

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. 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

1. 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

2. Patients receiving renal replacment therapy (RRT) for CKD

3. . Previously diagnosed with documented AKI in the last 30 days

4. Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the time of AKI diagnosis

5. Patient is not expected to survive throughout 28 days of study due to significant underlying medical condition

6. 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

7. Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis;

8. Pregnant or lactating women

9. Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atox Bio Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Azra Bihorac, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida Health

Locations

Maricopa Medical Center

Phoenix, Arizona, United States

Banner University Medical Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Loma Linda University Medical Center

Loma Linda, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

UCSD Medical Center

San Diego, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

UCH-Memorial Health System

Colorado Springs, Colorado, United States

University of Colorado Hospital

Denver, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

UF Health Shands Hospital

Gainesville, Florida, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

LSU Health Science Center

New Orleans, Louisiana, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, United States

University of Missouri

Columbia, Missouri, United States

Capital Health System, Inc.

Trenton, New Jersey, United States

Erie County Medical Center-Affliate of SUNYat Buffalo

Buffalo, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

University of Cincinnati Medical Center (UCMC)

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

The Pennsylvania State University and The Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

The Trauma Center at PENN

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

MUSC

Charleston, South Carolina, United States

John Peter Smith Health Network

Fort Worth, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Harborview Medical Center

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, 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

Countries

United States; France

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ATB-203

Identifier Type: -

Identifier Source: org_study_id