Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery
A 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
1 other identifier
interventional
351
1 country
27
Brief Summary
The purpose of this study was to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for AKI following CABG and/or valve surgery. This study also investigated 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedResults Posted
Study results publicly available
October 4, 2022
CompletedDecember 4, 2024
November 1, 2024
1.7 years
May 6, 2019
July 23, 2022
November 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 72 Hrs From End of Surgery (AKI-SCr72h)
Development of AKI was based on SCr criteria from the kidney disease improving global outcomes (KDIGO) guideline (i.e., increase in SCr ≥ 0.3 milligram per deciliter (mg/dL) \[≥ 26.5 micromoles per liter {μmol/L}\] within any 48 hours or increase in SCr to ≥ 1.5 times baseline within 72 hours after end of surgery \[T0\]). Percentage of participants who developed AKI-SCr72h were reported.
From end of surgery up to 72 hrs
Secondary Outcomes (5)
Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 7 Days From End of Surgery (AKI-SCr7d)
From end of surgery up to 7 days
Percentage of Participants Developing AKI Based on All Captured Criteria Within 72 Hrs From End of Surgery (AKI-KDIGO72h)
From end of surgery up to 72 hrs
Percentage of Participants Developing AKI Based on All Captured Criteria Within 7 Days From End of Surgery (AKI-KDIGO7d)
From end of surgery up to 7 days
Percentage of Participants With Major Adverse Kidney Events (MAKE) Within 30 Days After Day of Surgery (MAKE30)
From day of surgery up to 30 days
Percentage of Participants With MAKE Within 90 Days After Day of Surgery (MAKE90)
From day of surgery up to 90 days
Study Arms (3)
ASP1128
EXPERIMENTALParticipants received ASP1128 solution administered by 15 minutes intravenous infusion with in 24 hours after the end of surgery and thereafter once daily for 2 days.
Matching placebo
PLACEBO COMPARATORParticipants received placebo matched to ASP1128 solution administered by 15 minutes intravenous infusion with in 24 hours after the end of surgery and thereafter once daily for 2 days.
Observational cohort
NO INTERVENTIONParticipant with postoperative negative NephroCheck® (NC) (AKIRisk score was ≤ 0.3 nanogram per milliliter (ng/mL)\^2/1000 at all assessments between 2 to 22 hours after time point 0 (T0) were followed up for 90 days in observational cohort. Participants did not receive any intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
You may not qualify if:
- 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).
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Sarver Heart Center
Tucson, Arizona, 85724, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Health Park Medical Center
Fort Myers, Florida, 33908, United States
Shands Hospital
Gainesville, Florida, 32610, United States
Florida Hospital Pepin Heart Institute
Tampa, Florida, 33613, United States
Southern Illinois University
Springfield, Illinois, 62794, United States
Luthern Medical Group
Fort Wayne, Indiana, 46804, United States
IU Health - Methodist
Indianapolis, Indiana, 46202, United States
St. Vincent Heart Center
Indianapolis, Indiana, 46290, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
MercyOne Iowa Heart Center
Des Moines, Iowa, 50314, United States
Delmarva Heart, LLC
Salisbury, Maryland, 21804, United States
Ascension Genesys Hospital
Grand Blanc, Michigan, 48439, United States
Mid Michigan Medical Center
Midland, Michigan, 48670, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Baptist Medical Center
Jackson, Mississippi, 39202, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08035, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Fairview Hospital - Cleveland Clinic
Cleveland, Ohio, 44111, United States
ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor Scott & White Heart Hospital
Plano, Texas, 75093, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
WVU Heart and Vascular Institute
Morgantown, West Virginia, 26506, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Inc.
Study Officials
- STUDY DIRECTOR
Senior Director
Astellas Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
May 6, 2019
First Posted
May 8, 2019
Study Start
November 1, 2019
Primary Completion
July 26, 2021
Study Completion
October 20, 2021
Last Updated
December 4, 2024
Results First Posted
October 4, 2022
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.