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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

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ClinicalTrials.gov Identifier: NCT03941483
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury (AKI) Drug: ASP1128 Drug: Placebo Phase 2

Detailed Description:

The study will comprise a screening visit, followed by CABG and/or valve surgery on Day 1, double-blind treatment period and a follow-up period up to Day 90 in subjects with moderate/severe risk of AKI (acute kidney injury) at 2-6 hours post-surgery.

Subjects with low risk of AKI at 2-6 hour post-surgery assessment will be enrolled in the observational cohort to evaluate subject characteristics and biomarkers for exploratory objectives.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASP1128
Participants will receive ASP1128 solution intravenously once daily for 3 days.
Drug: ASP1128
Intravenous
Other Name: MA-0217

Placebo Comparator: Matching placebo
Participants will receive matching placebo solution intravenously once daily for 3 days.
Drug: Placebo
Intravenous

No Intervention: Observational cohort
Participants will be followed-up after the surgery up to Day 90.



Primary Outcome Measures :
  1. Proportion of participants developing acute kidney injury based on serum creatinine (SCr) criteria within 72 hrs (AKI-SCr72h) [ Time Frame: Up to 72 hrs ]
    Development of AKI will be judged based on SCr criteria from the kidney disease: improving global outcomes (KDIGO) guideline (i.e., increase in SCr ≥ 0.3 mg/dL [≥ 26.5 μmol/L] within any 48 hours, or increase in SCr to ≥ 1.5 times baseline) within 72 hours after end of surgery (T0).


Secondary Outcome Measures :
  1. Proportion of participants developing AKI based on SCr criteria within 7 days (AKI-SCr7d) [ Time Frame: Up to Day 7 ]
    Development of AKI will be judged based on SCr criteria from KDIGO guideline within 7 days after T0.

  2. Proportion of participants developing AKI based on all captured criteria within 72 hours (AKI-KDIGO72h) [ Time Frame: Up to 72 hrs ]
    Development of AKI will be judged based on all captured criteria from KDIGO guideline (i.e., AKI-SCr stage 1 to 3: increase in SCr ≥ 0.3 mg/dL [≥ 26.5 μmol/L] within any 48 hours, increase in SCr to ≥ 1.5 times baseline, and/or AKI-urinary output (UO) stage 2 and 3: urine volume < 0.5 mL/kg per hour for 12 consecutive hours) within 72 hours after T0.

  3. Proportion of participants developing AKI based on all criteria within 7 days (AKI-KDIGO7d) [ Time Frame: Up to Day 7 ]
    Development of AKI will be judged based on all criteria from KDIGO guideline within 7 days after T0.

  4. Proportion of participants with major adverse kidney events (MAKE) within 30 days (MAKE30) [ Time Frame: Up to Day 30 ]
    MAKE30 is defined as all-cause mortality, renal replacement therapy (RRT) and/or ≥ 25% sustained reduction in estimated glomerular filtration rate (eGFR) based on SCr within 30 days after day of surgery.

  5. Proportion of participants with MAKE within 90 days (MAKE90) [ Time Frame: Up to Day 90 ]
    MAKE90 is defined as all-cause mortality, RRT and/or ≥ 25% sustained reduction in eGFR based on SCr within 90 days after day of surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 has moderate/high risk of developing acute kidney injury (AKI) following surgery:

    • Only CABG or single valve surgery: subject must have at least 2 AKI risk factors at screening
    • Combined CABG and surgery for 1 or more valves: subject must have at least 1 AKI risk factor at screening
    • Surgery for more than 1 cardiac valve: subject must have at least 1 AKI risk factor at screening
    • Surgery for aortic root or ascending aorta without circulatory arrest: subject must have at least 1 AKI risk factor at screening

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.

Exclusion 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 a known history of eGFR < 30 mL/min per 1.73 m^2 as per CKD-EPI or MDRD equation at any time before 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941483


Contacts
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Contact: Astellas Pharma Inc. 800-888-7704 Astellas.registration@astellas.com

Locations
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United States, Alabama
Heart Center Research, LLC Recruiting
Huntsville, Alabama, United States, 35801
United States, Arizona
Sarver Heart Center Recruiting
Tucson, Arizona, United States, 85724
United States, California
JEHM clinical Research Group Recruiting
Palm Springs, California, United States, 92262
United States, Florida
HealthPark Medical Center Recruiting
Fort Myers, Florida, United States, 33908
University of Florida- Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Florida Hospital Pepin Heart Institute Recruiting
Tampa, Florida, United States, 33613
United States, Indiana
St. Vincent Heart Center Recruiting
Indianapolis, Indiana, United States, 46290
Indiana University Health Ball Memorial Hospital Recruiting
Muncie, Indiana, United States, 47303
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
United States, Michigan
Ascension Genesys Hospital Recruiting
Grand Blanc, Michigan, United States, 48439
United States, Mississippi
Baptist Medical Center Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Lourdes Cardiology Services Recruiting
Voorhees, New Jersey, United States, 08035
United States, North Carolina
Duke Hospital and Health Center Recruiting
Durham, North Carolina, United States, 27710
Moses H. Cone Memorial Hospital Recruiting
Greensboro, North Carolina, United States, 27401
United States, Ohio
ProMedica Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Scott & White Heart Hospital Recruiting
Plano, Texas, United States, 75093
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Study Physician Astellas Pharma Inc

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03941483     History of Changes
Other Study ID Numbers: 1128-CL-0201
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases