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Trial record 1 of 1 for:    ASP1128
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941483
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03941483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury (AKI)
Intervention  ICMJE
  • Drug: ASP1128
    Intravenous
    Other Name: MA-0217
  • Drug: Placebo
    Intravenous
Study Arms  ICMJE
  • Experimental: ASP1128
    Participants will receive ASP1128 solution intravenously once daily for 3 days.
    Intervention: Drug: ASP1128
  • Placebo Comparator: Matching placebo
    Participants will receive matching placebo solution intravenously once daily for 3 days.
    Intervention: Drug: Placebo
  • No Intervention: Observational cohort
    Participants will be followed-up after the surgery up to Day 90.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Astellas Pharma Inc. 800-888-7704 Astellas.registration@astellas.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941483
Other Study ID Numbers  ICMJE 1128-CL-0201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Physician Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP