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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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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.

Participants 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.

Participants 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.

Participant 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.

Redacted CSR Synopsis English

PLS_English-1128-CL-0201.docx

Redacted Protocol

Statistical Analysis Plan (SAP)

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.

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

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.

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Link to plain language summary of the study on the Trial Results Summaries website

Link to results and other applicable study documents on the Astellas Clinical Trials website

Keck School of Medicine USC

ProMedica Toledo Hospital

Sarver Heart Center

Baylor Scott & White Heart Hospital

Florida Hospital Pepin Heart Institute

Indiana University Health Ball Memorial Hospital

Delmarva Heart, LLC

WVU Heart and Vascular Institute

St. Vincent Heart Center

Minneapolis Heart Institute

Ascension Genesys Hospital

JEHM clinical Research Group

Fairview Hospital - Cleveland Clinic

Maine Medical Center

Inova Heart and Vascular Institute

University of Texas Health Science Center

VA Medical Center

Health Park Medical Center

University of Florida- Jacksonville

Baptist Medical Center

Medical City Dallas Hospital

Southern Illinois University

Vanderbilt University

Shands Hospital

IU Health - Methodist

Duke University Medical Center

Luthern Medical Group

Barnes Jewish Hospital

Lourdes Cardiology Services

Hartford Hospital

Jacksonville Center for Clinical Research

Heart Center Research, LLC

Morton Plant Hospital

Moses H. Cone Memorial Hospital

Mid Michigan Medical Center

University Hospitals - Cleveland Medical Center

MercyOne Iowa Heart Center

University of Utah Hospitals and Clinics

University of Oklahoma

University of Virginia Health System

St. Luke's Hospital of Kansas City

Columbia University Irving Medical Center

Medical University of South Carolina

Temple University Hospital

Suburban Hospital Inc

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

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)).

Age Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Randomization was stratified for estimated glomerular filtration rate (eGFR) at < 45 and ≥ 45 mL/min per 1.73 m^2.

Estimated Glomerular Filtration Rate (eGFR) for randomization

eGFR was meant to be collected for randomized participants (ASP1128 and Placebo) only.

Study Specific Characteristic

ASP1128 and Placebo: Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study treatment.
Observational Cohort: NC negative participants who were enrolled  in the observational cohort.

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.

FAS consisted of all randomized participants who received at least 1 dose of study treatment. The outcome measure was planned to be analyzed for ASP1128 and Placebo only.

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 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.

FAS Population. The outcome measure was planned to be analyzed for ASP1128 and Placebo only.

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 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.

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 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.

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

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.

Percentage of Participants with Major Adverse Kidney Events (MAKE) Within 30 days After Day of Surgery (MAKE30)

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.

Percentage of Participants with MAKE Within 90 days After Day of Surgery  (MAKE90)

Overall Study

Participants who underwent coronary artery bypass graft (CABG) and/or valve surgery and had a moderate or high risk for developing acute kidney injury (AKI) based on serum creatinine (SCr) kidney disease improving global outcomes (KDIGO) criteria (AKI-SCr) postsurgery were enrolled in the study. Randomization was stratified for estimated glomerular filtration rate (eGFR) at < 45 and ≥ 45 milliliter per minute (mL/min) per 1.73 square meter (m^2).

Clinical Trial Disclosure

Development of AKI will be judged based on SCr criteria from KDIGO guideline within 7 days after T0.

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.

Development of AKI will be judged based on all criteria from KDIGO guideline 
within 7 days after T0.

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.

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.