Status:
COMPLETED
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Intraoperative Ureter Visualization
Abdominolpelvic Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, althou...
Eligibility Criteria
Inclusion
- Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter identification
- Participant has normal renal function or has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and calculated by individual estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease formula
- Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min
- Adult moderate/severe eGFR cohort: eGFR ≥ 15 to \< 60 mL/min
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential
- Woman of childbearing potential who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration.
- Female participant must agree not to breastfeed starting at the administration of ASP5354 through 30 days after ASP5354 administration.
- Female participant must not donate ova starting at the administration of ASP5354 through 30 days after ASP5354 administration.
- Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception through at least 30 days after ASP5354 administration.
- Male participant must not donate sperm starting at the administration of ASP5354 through 30 days after ASP5354 administration.
- Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy from the start of ASP5354 administration through 30 days after ASP5354 administration.
- Participant agrees not to participate in another interventional study involving unapproved study medications while participating in the present study.
Exclusion
- Participant has any physical or psychiatric condition, which makes the participant unsuitable for study participation.
- Participant is anticipated to require ureteral stenting during surgery.
- Participant has an active urinary tract infection requiring antibiotic therapy.
- Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions would impact safety or study compliance.
- Participant has any clinically relevant laboratory abnormality that could contraindicate surgery.
- Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
- Participant has had previous exposure to ASP5354.
- Participant has been administered ICG or other NIR-F imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery.
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to randomization.
- Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis.
Key Trial Info
Start Date :
March 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05999747
Start Date
March 19 2024
End Date
October 13 2025
Last Update
November 5 2025
Active Locations (12)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
3
University of South Florida
Tampa, Florida, United States, 33606
4
Cleveland Clinic Florida
Weston, Florida, United States, 33331