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 : November 15, 2019
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Participants will receive ASP1128 solution intravenously once daily for 3 days.
Other Name: MA-0217
Placebo Comparator: Matching placebo
Participants will receive matching placebo solution intravenously once daily for 3 days.
No Intervention: Observational cohort
Participants will be followed-up after the surgery up to Day 90.
- 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).
- 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.
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
|Contact: Astellas Pharma Inc.||800-888-7704||Astellas.firstname.lastname@example.org|
|United States, Alabama|
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|Huntsville, Alabama, United States, 35801|
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|Muncie, Indiana, United States, 47303|
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|Portland, Maine, United States, 04102|
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|Ascension Genesys Hospital||Recruiting|
|Grand Blanc, Michigan, United States, 48439|
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|Moses H. Cone Memorial Hospital||Recruiting|
|Greensboro, North Carolina, United States, 27401|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Study Director:||Study Physician||Astellas Pharma Inc|