A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)
A Multi-Center, Parallel-Group, Randomized, Double Blind, Adaptive Study Investigating the Safety and Efficacy of THR-184 in Patients at Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)
2 other identifiers
interventional
452
2 countries
41
Brief Summary
The purpose of this study is to determine whether THR-184 when administered around the time of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the development of acute kidney injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
41 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
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
April 20, 2017
CompletedApril 20, 2017
March 1, 2017
2.3 years
April 10, 2013
November 17, 2016
March 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Acute Kidney Injury (AKI)
Acute kidney injury (AKI) is defined using the KDIGO criteria, in which AKI is defined as any of the following: * Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or * Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * Urine volume \<0.5 ml/kg/h for 6 hours.
7 days
Secondary Outcomes (3)
Incidence of AKI
7 days
Severity of AKI
7 days
Duration of AKI
7 days OR up to discharge after surgery
Other Outcomes (1)
Composite of Death, Dialysis, or Sustained Impaired Renal Function
Day 30
Study Arms (5)
Placebo
PLACEBO COMPARATORAn identical appearing placebo will be administered.
THR-184 Dose 1
EXPERIMENTALTHR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.
THR-184 Dose 2
EXPERIMENTALTHR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.
THR-184 Dose 3
EXPERIMENTALTHR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.
THR-184 Dose 4
EXPERIMENTALTHR-184 initial pre-surgery high dose followed by (3) post surgery doses \~80% of the pre-surgery dose.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female and \>18 years of age.
- Scheduled for a non-emergent coronary and/or valve surgery procedure requiring CPB, to include:
- coronary artery bypass graft (CABG) alone;
- aortic valve replacement or repair alone, with or without aortic root repair;
- mitral, tricuspid, or pulmonic valve replacement or repair alone;
- simultaneous replacement of several cardiac valves;
- CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair;
- CABG with combined cardiac valve replacement or repair.
- Have the following risk factors for CSA-AKI:
- eGFR ≥ 20 and \< 30 ml/min/1.73m2 OR
- eGFR ≥ 30 and \< 60 ml/min/1.73m2 and ONE of the following additional risk factors (other than age ≥ 75 years) OR
- eGFR ≥ 60 ml/min/1.73m2 and TWO of the following additional risk factors
- Additional Risk Factors:
- Age ≥ 75 years;
- Combined valve \& coronary surgery;
- +6 more criteria
You may not qualify if:
- If any of the following criteria apply prior to surgery, the patient will be excluded from the study:
- Age \> 85 years;
- Weight \>174 kg or 383 lbs;
- The presence of AKI (KDIGO criteria) at the time of screening ;
- Surgery to be performed without CPB;
- Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°Celsius (82.4° Fahrenheit);
- eGFR (MDRD) \<20 ml/min/1.73m2;
- Surgery for aortic dissection;
- Surgery to correct a major congenital heart defect (e.g., Tetralogy of Fallot, transposition of the great vessels, single ventricle, Ebsteins anomaly. Bicuspid aortic valve is not to be considered a congenital heart defect.);
- Prior organ transplantation;
- Dialysis-dependence;
- Administration of iodinated contrast media within 24 hours prior to cardiac surgery;
- If received contrast media prior to 24 hours and have AKI as defined by KDIGO criteria;
- Cardiogenic shock or haemodynamic instability within the 24 hours prior to surgery, including the anesthesia induction period; as defined by a systolic BP \<80 mm Hg and pulse \>120 beats per minute (bpm) and requirement for inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP);
- Requirement for any of the following within seven (7) days prior to cardiac surgery:
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University of Alabama-Birmingham
Birmingham, Alabama, 35294, United States
University of Southern California
Los Angeles, California, 90033, United States
Stanford University
Stanford, California, 94305, United States
Harbor - University of California Los Angeles Medical Center
Torrance, California, 90503, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
River City Clinical Research
Jacksonville, Florida, 32207, United States
University of Chicago
Chicago, Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Indiana Ohio Heart
Fort Wayne, Indiana, 46804, United States
Indiana Heart-St. Vincent Medical Group
Indianapolis, Indiana, 46290, United States
Maine Medical Center
Portland, Maine, 04102, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Covenant Medical Center
Saginaw, Michigan, 48602, United States
Washington University
St Louis, Missouri, 63110, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
St. Peter's Hospital
Albany, New York, 12208, United States
Columbia University
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Durham VA Medical Center
Durham, North Carolina, 27710, United States
Lindner Research Center-Christ Hospital
Cincinnati, Ohio, 45219, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Erlanger Health System
Chattanooga, Tennessee, 37404, United States
Memorial Hospital
Chattanooga, Tennessee, 37404, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Baylor University Medical Center, Soltero Cardiovascular Research Center
Dallas, Texas, 75226, United States
University of Texas, Houston
Houston, Texas, 77030, United States
Cardiothoracic Surgical Associates
Richmond, Virginia, 23225, United States
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
St-John Regional Hospital Facility
Saint John, New Brunswick, E2L4L2, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Institut de Cardiologie de Montréal
Montreal, Quebec, H1T 1C8, Canada
Centre hospitalier de l'université de Montréal(CHUM)- Hôtel-Dieu
Montreal, Quebec, H2W 1T8, Canada
MUHC - Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Sacre Cœur Hospital
Montreal, Quebec, H4J 1C5, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A limitation of this analysis was that if a subject left the hospital with AKI, the duration of AKI was automatically assigned as 7 days.
Results Point of Contact
- Title
- Jerome Rossert, MD, PhD, Chief Scientific Officer
- Organization
- Thrasos Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Andreas Orfanos, MBBCh
Thrasos Innovation, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 12, 2013
Study Start
May 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
April 20, 2017
Results First Posted
April 20, 2017
Record last verified: 2017-03