Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus…
- Trial name
- NCT02921789
- Testing
- Bleselumab, Basiliximab, Mycophenolate Mofetil (MMF)
- Where
- 23 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers, Renal Impairment
A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well
The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05495581
- Testing
- pudexacianinium chloride
- Where
- 4 sites in United States, Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML).
- Trial name
- NCT02014558
- Testing
- Gilteritinib, Voriconazole, Midazolam
- Where
- 26 sites in United States, Germany and 1 more
- Volunteers
- 265 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and…
- Trial name
- NCT03730012
- Testing
- gilteritinib, atezolizumab
- Where
- 12 sites in United States
- Volunteers
- 11 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-Small-Cell Lung Cancer
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215.
- Trial name
- NCT02495233
- Testing
- Gilteritinib, Erlotinib
- Where
- 4 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1)…
- Trial name
- NCT02927262
- Testing
- Gilteritinib
- Where
- 73 sites in United States, Brazil and 19 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Menopause, Hot Flashes
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes.
- Trial name
- NCT03192176
- Testing
- Fezolinetant
- Where
- 51 sites in United States
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
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)
The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517.
- Trial name
- NCT04079296
- Testing
- ASP7517
- Where
- 16 sites in United States, Japan
- Volunteers
- 43 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Chronic Tympanic Membrane Perforation
A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)
The primary purpose of this study was to evaluate the safety and tolerability of ASP0598 Otic Solution. This study also evaluated the efficacy of ASP0598 otic solution.
- Trial name
- NCT04305184
- Testing
- ASP0598
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Overactive Bladder (OAB)
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
- Trial name
- PILLAR (NCT02216214)
- Testing
- Mirabegron
- Where
- 120 sites in United States, Canada
- Volunteers
- 888 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants
The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine.
- Trial name
- NCT04448561
- Testing
- ASP8082, morphine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study
The purpose of this study is to quantify and publish participants' relative preferences for outcomes of chemotherapy and novel oral hormonal agents when added to androgen deprivation therapy (ADT) for participants with…
- Trial name
- NCT05381311
- Where
- United States
- Volunteers
- 1,020 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062.
- Trial name
- NCT04447287
- Testing
- ASP8062, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer
A Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer
The primary purpose of this study is to determine the effect of multiple once daily administrations of enzalutamide on the pharmacokinetics of a single dose of digoxin (P-glycoprotein (P-gp) substrate) and rosuvastatin (breast…
- Trial name
- NCT04094519
- Testing
- enzalutamide, digoxin, rosuvastatin
- Where
- Moldova
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors
A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.
- Trial name
- NCT02057380
- Testing
- linsitinib, erlotinib, paclitaxel
- Where
- 12 sites in United States, Brazil and 5 more
- Volunteers
- 13 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer, Castration-resistant Prostate Cancer
Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
The purpose of this study is to describe patterns of care in CRPC patients, as well as health-related quality of life (HRQoL) outcomes associated with CRPC and its management.
- Conditions
- Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
- Trial name
- TRUMPET (NCT02380274)
- Where
- 148 sites in United States
- Volunteers
- 1,030 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of…
- Trial name
- NCT04096157
- Testing
- Isavuconazonium sulfate IV, Isavuconazonium sulfate capsules
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-small Cell Lung Cancer (NSCLC), Epidermal Growth Factor Receptor (EGFR) Mutations
A Study of ASP8273 in Subjects With Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations
The objective of this study is to evaluate the bioequivalence of a tablet formulation versus a capsule formulation of ASP8273 following a single dose under fasted condition in subjects with non-small cell lung cancer (NSCLC)…
- Trial name
- NCT03082300
- Testing
- naquotinib
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Participants
A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults
ASP8731 is a potential new treatment for people with sickle cell disease. Before ASP8731 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body.
- Trial name
- NCT05167526
- Testing
- ASP8731
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors, Acute Myeloid Leukemia
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical…
- Trial name
- NCT02561455
- Testing
- Gilteritinib
- Where
- 7 sites in United States
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.