Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT05754333
Eligibility Criteria:
Inclusion Criteria:
* Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter(s) 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 eGFR using the modification of diet in renal disease (MDRD) formula for adults or the Schwartz formula for adolescents at the screening visit.
* Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min
* Adult moderate/severe eGFR cohort: eGFR ≥ 15 to \< 60 mL/min
* Adolescent cohort: eGFR ≥ 60 mL/min
* Female participant is not pregnant and at least 1 of the following conditions apply:
* Not a woman of childbearing potential (WOCBP).
* WOCBP 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 (and/or participant's parent or legal guardian) agrees not to participate in another interventional study involving unapproved study medication while participating in the present study.
Exclusion Criteria:
* 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 that would impact safety or study compliance.
* Participant has any clinically relevant laboratory abnormality that could contraindicate surgery.
* Participant with body weight \< 30 kilogram (kg).
* 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 near-infrared fluorescent (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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05754333
Study Brief:
Protocol Section:
NCT05754333