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8110 Gatehouse Road, Falls Church, VA 22042

Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled 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

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

n/a

Background Information

Various factors contribute to the development of acute kidney injury (AKI) following cardiovascular surgery. These include the use of nephrotoxic agents, renal hypoxia, hemodilution, toxins released after blood cell injury, oxidative stress, and inflammation (Fuhrman 2017, Thiele 2015). So far there is no medical treatment for AKI.

ASP1128 (also known as MA- 2017) is being developed to prevent AKI or reduce its severity in subjects who are at increased risk of developing moderate to severe AKI after CABG and/ or valve surgery. The purpose of this study is to evaluate the efficacy of post-surgery treatment with ASP1128 in subjects at risk for 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.

Offered At

Inova Heart and Vascular Institute
Inova Fairfax Medical Campus
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Eric L. Sarin, MD

Eligibility Information

  • Subject is ≥ 35 years of age at the time of screening
  • Subject undergoing non-emergent open chest cardiovascular surgery with the use of CPB (i.e., CABG and/or valve surgery [including aortic root and ascending aorta surgery without cardiac arrest]) within 4 weeks of screening
  • Subject has moderate to high risk of developing AKI following surgery as determined by the Principal Investigator
  • Subject must have the ability, in the opinion of the Principal Investigator, and willingness to return for all scheduled visits and perform all assessments.
  • A female subject is eligible to participate if she is not pregnant or practicing contraception as per study guidelines.

Ineligibility Information

At Screening:

  • Subject has received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening
  • Subject has received renal replacement therapy (RRT) within 30 days prior to screening
  • Subject has a known history of eGFR < 30 mL/min/1.73 m2 as per CKD-EPI or MDRD at any time before screening
  • Subject has 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 medications as specified in the concomitant medication section of the protocol
  • 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 (as assessed in visit 1 sample):
    • 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/1.73 m2 as per CKD-EPI equation
  • Subject has use of left ventricular assist device, intra-aortic balloon pump or other cardiac devices, or catecholamine’s 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 as per the discretion of the investigator
  • 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.

Ineligibility Information (Preoperatively on the Day of Surgery):

  • Subject has AKI (any stage) present at presurgery baseline at the discretion of the Principal Investigator
  • Subject has known or suspected infection/sepsis at time of presurgery baseline at the discretion of investigator

Ineligibility Information (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

Ineligibility Information (General):

  • Subject has other condition, which, in the Principal Investigator’s opinion, 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