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Acute Kidney Injury (AKI)Phase 2NCT03941483

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 study testing ASP1128 in people with Acute Kidney Injury (AKI), run by Astellas Pharma Inc at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Acute Kidney Injury (AKI)
What is being tested?
ASP1128
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
351 participants
Where
27 sitesUnited States
Study dates
1 Nov 2019to 20 Oct 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
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  • 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.

Who cannot join

  • 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).
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  • 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:
  • 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.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Fairview Hospital - Cleveland Clinic

    Cleveland, Ohio, 44111

  • MercyOne Iowa Heart Center

    Des Moines, Iowa, 50314

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Health Park Medical Center

    Fort Myers, Florida, 33908

  • Luthern Medical Group

    Fort Wayne, Indiana, 46804

  • Shands Hospital

    Gainesville, Florida, 32610

  • Ascension Genesys Hospital

    Grand Blanc, Michigan, 48439

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27401

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • IU Health - Methodist

    Indianapolis, Indiana, 46202

  • St. Vincent Heart Center

    Indianapolis, Indiana, 46290

  • Baptist Medical Center

    Jackson, Mississippi, 39202

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Mid Michigan Medical Center

    Midland, Michigan, 48670

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • WVU Heart and Vascular Institute

    Morgantown, West Virginia, 26506

  • Indiana University Health Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Baylor Scott & White Heart Hospital

    Plano, Texas, 75093

  • Delmarva Heart, LLC

    Salisbury, Maryland, 21804

  • University of Texas Health Science Center

    San Antonio, Texas, 78229

  • Southern Illinois University

    Springfield, Illinois, 62794

  • Florida Hospital Pepin Heart Institute

    Tampa, Florida, 33613

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

  • Sarver Heart Center

    Tucson, Arizona, 85724

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08035

Other trials in United States

About this study

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

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.

Read the detailed description

The study comprised of 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 at 2-22 hours post-surgery.

Subjects with low risk of AKI at 2-22 hours post-surgery assessment were enrolled in the observational cohort to evaluate subject characteristics and biomarkers for exploratory objectives.

Being tested
ASP1128, Placebo
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP1128Drug

    Also called MA-0217

    Intravenous Infusion

  • PlaceboDrug

    Intravenous Infusion

Study groups in NCT03941483
Study groupRoleWhat they receive
ASP1128ExperimentalParticipants 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.
Receives: Drug: ASP1128
Matching placeboPlacebo 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.
Receives: Drug: Placebo
Observational cohortNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From end of surgery up to 72 hrs

Secondary outcomes (5)

  1. Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 7 Days From End of Surgery (AKI-SCr7d)

    Development of AKI was based on SCr criteria from the 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 7 days after T0). Percentage of participants who developed AKI-SCr7d were reported.

    Measured: From end of surgery up to 7 days

  2. Percentage of Participants Developing AKI Based on All Captured Criteria Within 72 Hrs From End of Surgery (AKI-KDIGO72h)

    Development of AKI was 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. Percentage of participants who developed AKI-KDIGO72h were reported.

    Measured: From end of surgery up to 72 hrs

  3. Percentage of Participants Developing AKI Based on All Captured Criteria Within 7 Days From End of Surgery (AKI-KDIGO7d)

    Development of AKI was 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 milliliter per kilogram (mL/kg) per hour for 12 consecutive hours) within 7 days after T0. Percentage of participants who developed AKI-KDIGO7d were reported.

    Measured: From end of surgery up to 7 days

  4. Percentage of Participants With Major Adverse Kidney Events (MAKE) Within 30 Days After Day of Surgery (MAKE30)

    MAKE30 was 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. Percentage of participants with MAKE30 were reported.

    Measured: From day of surgery up to 30 days

  5. Percentage of Participants With MAKE Within 90 Days After Day of Surgery (MAKE90)

    MAKE90 was defined as all-cause mortality, renal replacement therapy (RRT) and/or ≥ 25% sustained reduction in estimated glomerular filtration rate (eGFR) based on SCr within 90 days after day of surgery. Percentage of participants with MAKE90 were reported.

    Measured: From day of surgery up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start1 Nov 2019
  3. Primary completion26 Jul 2021
  4. Study completion20 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941483
Sponsor's protocol ID
1128-CL-0201
Status last verified
Nov 2024
First submitted
6 May 2019
Last updated
4 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP1128 in people with Acute Kidney Injury (AKI), run by Astellas Pharma Inc at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 72 Hrs From End of Surgery (AKI-SCr72h) (time frame: From end of surgery up to 72 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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