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Astellas Study ID
1128-CL-0201

Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

Astellas Study ID
1128-CL-0201
Clinicaltrials.gov ID
NCT03941483
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The purpose of this study is to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for acute kidney injury (AKI) following CABG and/or valve surgery.

This study will also investigate the safety and tolerability of postsurgery treatment with ASP1128, and pharmacokinetic characteristics of ASP1128 in subjects at risk for AKI following CABG and/or valve surgery.

Additional Study Details

Phase
Phase 2
Product
ASP1128
Product
ASP1128
Placebo
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
220
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Would you like more information about clinical trial sites that are recruiting participants for Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery? Contact us by filling out your information to the right and we’ll respond to you.

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  • Canada
  • Chile
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  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
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  • Former Serbia and Montenegro
  • France
  • Georgia
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  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

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    Locations

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    Keck School of Medicine USC
    Los Angeles, CA, United States, 90033
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    ProMedica Toledo Hospital
    Toledo, OH, United States, 43606
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    Sarver Heart Center
    Tucson, AZ, United States, 85724
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    Baylor Scott & White Heart Hospital
    Plano, TX, United States, 75093
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    Florida Hospital Pepin Heart Institute
    Tampa, FL, United States, 33613
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    Indiana University Health Ball Memorial Hospital
    Muncie, IN, United States, 47303
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    Delmarva Heart, LLC
    Salisbury, MD, United States, 21804
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    WVU Heart and Vascular Institute
    Morgantown, WV, United States, 26506
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    St. Vincent Heart Center
    Indianapolis, IN, United States, 46290
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    Minneapolis Heart Institute
    Minneapolis, MN, United States, 55407
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    Ascension Genesys Hospital
    Grand Blanc, MI, United States, 48439
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    JEHM clinical Research Group
    Palm Springs, CA, United States, 92262
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    Fairview Hospital - Cleveland Clinic
    Cleveland, OH, United States, 44111
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    Maine Medical Center
    Portland, ME, United States, 04102
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    Inova Heart and Vascular Institute
    Falls Church, VA, United States, 22042
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    University of Texas Health Science Center
    San Antonio, TX, United States, 78229
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    VA Medical Center
    Washington, DC, United States, 20422
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    Health Park Medical Center
    Fort Myers, FL, United States, 33908
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    University of Florida- Jacksonville
    Jacksonville, FL, United States, 32209
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    Baptist Medical Center
    Jackson, MS, United States, 39202
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    Medical City Dallas Hospital
    Dallas, TX, United States, 75230
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    Southern Illinois University
    Springfield, IL, United States, 62794
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    Vanderbilt University
    Nashville, TN, United States, 37232
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    Shands Hospital
    Gainesville, FL, United States, 32610
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    IU Health - Methodist
    Indianapolis, IN, United States, 46202
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    Duke University Medical Center
    Durham, NC, United States, 27710
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    Luthern Medical Group
    Fort Wayne, IN, United States, 46804
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    Barnes Jewish Hospital
    St. Louis, Mo, United States, 63110
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    Lourdes Cardiology Services
    Voorhees, NJ, United States, 08035
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    Hartford Hospital
    Hartford, CT, United States, 06102
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    Jacksonville Center for Clinical Research
    Jacksonville, FL, United States, 32207
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    Heart Center Research, LLC
    Huntsville, AL, United States, 35801
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    Morton Plant Hospital
    Clearwater, FL, United States, 33756
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    Moses H. Cone Memorial Hospital
    Greensboro, NC, United States, 27401
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    Mid Michigan Medical Center
    Midland, MI, United States, 48670
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    University Hospitals - Cleveland Medical Center
    Cleveland, OH, United States, 44106
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    MercyOne Iowa Heart Center
    Des Moines, IA, United States, 50314
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    University of Utah Hospitals and Clinics
    Salt Lake City, UT, United States, 84132
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    University of Oklahoma
    Oklahoma City, OK, United States, 73104
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    University of Virginia Health System
    Charlottesville, VA, United States, 22908
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    St. Luke's Hospital of Kansas City
    Kansas City, Mo, United States, 64111
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    Columbia University Irving Medical Center
    New York, NY, United States, 10032
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    Medical University of South Carolina
    Charleston, SC, United States, 29425
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    Trial info
    Follow Trial
    Age
    35+ years
    Diamond icon
    Condition
  • Kidney Disease
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Nov 2019 - Jan 2022
    Additional Study Details
    Inclusion Criteria
    • Subject agrees not to participate in another interventional study after signing the informed consent form and until the end of study (EoS) visit has been completed.
    • Subject is ≥ 35 years of age at the time of screening (visit 1).
    • Subject undergoing non-emergent open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB) (i.e., coronary artery bypass graft (CABG) and/or valve surgery [including aortic root and ascending aorta surgery without circulatory arrest]) within 4 weeks of screening (visit 1).
    • Subject is at risk of developing acute kidney injury (AKI) following cardiovascular surgery, i.e., has 1 or more of the following AKI risk factors:
      • Age at screening of ≥ 70 years
      • Documented history of eGFR < 60 mL/min per 1.73 m^2 as per Modification of Diet in Renal Disease Study (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (or documented measured glomerular filtration rate assessment) (history needs to be present for at least 90 days prior to screening, and eGFR at screening or baseline needs to be < 60 mL/min per 1.73 m^2, as well as per CKD-EPI equation.)
      • Documented history of congestive heart failure requiring hospitalization. This condition should exist for ≥ 90 days prior to screening.
      • Documented history of diabetes mellitus (type 1 or 2) of ≥ 90 days prior to screening, and subject is on active antidiabetic medication treatment for ≥ 90 days.
      • Documented history of proteinuria/albuminuria at any time point before screening (urinary dipstick result of ≥ 2+, documented urinary albumin creatinine ratio measurement of ≥ 300 mg/g, or documented total quantity of protein in a 24-hour urine collection test ≥ 0.3 g/day)
    • Subject must have the ability and willingness to return for all scheduled visits and perform all assessments.
    • Female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
      • Not a woman of childbearing potential (WOCBP), OR
      • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 30 days after the final study drug administration.
    • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 30 days after the final study drug administration.
    • Female subject must not donate ova starting at screening and throughout the study period, and for 30 days after the final study drug administration.
    • Male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 30 days after the final study drug administration.
    • Male subject must not donate sperm during the treatment period and for at least 30 days after the final study drug administration.
    • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 30 days after the final study drug administration.
    MaximizeExclusion Criteria

      At Screening:

    • Subject has received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening.
    • Subject has received RRT within 30 days prior to screening.
    • Subject has CKD stage 4 or 5, or stage 3 (i.e., eGFR 30-59 mL/min per 1.73m^2) with a known history of eGFR < 30 mL/min per 1.73 m^2 as per CKD-EPI or MDRD equation within 6 months prior to screening.
    • Subject has a prior kidney transplantation.
    • Subject has a known or suspected glomerulonephritis (other than Diabetic Kidney Disease).
    • Subject has confirmed or treated endocarditis or other current active infection requiring antibiotic treatment within 30 days prior to screening.
    • Subject is using prohibited.
    • Subject has a prior history of intravenous drug abuse within 1 year prior to screening.
    • Subject has a known chronic liver disorder with Child-Pugh B or C classification.
    • Subject has any of the following abnormal liver or kidney function parameters:
      • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) or bilirubin increased to > 1.5 times the ULN.
      • eGFR < 30 mL/min per 1.73 m^2 as per CKD-EPI equation.
    • Subject has use of left ventricular assist device, intra-aortic balloon pump or other cardiac devices, or catecholamines within 7 days prior to screening.
    • Subject has surgery scheduled to be performed without CPB (i.e., “Off-Pump” surgery).
    • Subject has surgery scheduled to be performed under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest.
    • Subject has surgery scheduled for aortic dissection.
    • Subject has surgery for a condition that is immediately life-threatening.
    • Subject has surgery scheduled to correct major congenital heart defect.
    • Subject has current or previous malignant disease. Subjects with a history of cancer are considered eligible if the subject has undergone therapy and the subject has been considered disease free or progression free for at least 5 years. Subject with completely excised basal cell carcinoma or squamous cell carcinoma of the skin and completely excised cervical cancer in situ are also considered eligible.

      • Preoperatively on the Day of Surgery:

    • Exclusion criteria 1 to 17 are applicable at this time.
    • Subject has AKI (any stage) present at presurgery baseline.
    • Subject has known or suspected infection/sepsis at time of presurgery baseline.

      • Perioperative Exclusion Criteria:

    • Subject requires Extracorporeal Membrane Oxygenation during or after completion of surgery.
    • Subject requires ventricular assist device during or after completion of surgery.
    • Subject has surgery performed “Off-Pump” at any time during surgery.

      • General:

    • Subject has other condition, which makes the subject unsuitable for study participation.
    • Female subject who is pregnant or lactating or has a positive pregnancy test within 72 hours prior to screening and/or randomization, has been pregnant within 6 months before screening assessment or breastfeeding within 3 months before screening or who is planning to become pregnant within the total study period.
    • Subject has a known or suspected hypersensitivity to ASP1128 or any components of the formulation used.

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