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

PHASE3TerminatedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

May 24, 2018

Primary Completion Date

December 14, 2019

Study Completion Date

December 14, 2019

Conditions
Acute Kidney InjuryPeritonitisNecrotizing Soft Tissue Infection
Interventions
DRUG

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

DRUG

Placebo

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

Trial Locations (56)

14215

Erie County Medical Center-Affliate of SUNYat Buffalo, Buffalo

17033

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

18015

St. Luke's University Health Network, Bethlehem

19104

The Trauma Center at PENN, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20010

Washington Hospital Center, Washington D.C.

21201

University of Maryland, Baltimore, Baltimore

24857

Banner University Medical Center, Tucson

27834

East Carolina University, Greenville

28208

Carolinas Medical Center, Charlotte

29425

MUSC, Charleston

32610

UF Health Shands Hospital, Gainesville

40536

University of Kentucky, Lexington

43210

The Ohio State University, Columbus

45219

University of Cincinnati Medical Center (UCMC), Cincinnati

48109

University of Michigan, Ann Arbor

48202

Henry Ford Health System, Detroit

52242

University of Iowa Hospital and Clinics, Iowa City

55415

Hennepin County Medical Center, Minneapolis

55435

Fairview Southdale Hospital, Edina

55455

University of Minnesota Medical Center-Fairview, Minneapolis

65211

University of Missouri, Columbia

70012

LSU Health Science Center, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

76104

John Peter Smith Health Network, Fort Worth

78229

University of Texas Health Science Center at San Antonio, San Antonio

80045

University of Colorado Hospital, Denver

80909

UCH-Memorial Health System, Colorado Springs

85008

Maricopa Medical Center, Phoenix

90502

Harbor-UCLA Medical Center, Torrance

92103

UCSD Medical Center, San Diego

92354

Loma Linda University Medical Center, Loma Linda

95817

University of California, Davis Medical Center, Sacramento

97239

Oregon Health and Science University, Portland

98104

Harborview Medical Center, Seattle

98195

University of Washington Medical Center, Seattle

98638

Capital Health System, Inc., Trenton

06520

Yale New Haven Hospital, New Haven

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Atox Bio Ltd

INDUSTRY

NCT03403751 - Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury | Biotech Hunter | Biotech Hunter