A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery

A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near Infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries

The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. This study was about a potential new medical dye, called ASP5354. This dye was injected into the person at the start of surgery and was detected in the ureter. This was done by an imaging machine which had an option called near infrared fluorescence, or NIR-F. Together they showed live images of specific parts of the body. In this study, ASP5354 was used with an imaging machine with a NIR-F option to show live images of the ureter during surgery. People with kidneys that work properly and those with kidney problems could take part. The main aim of the study was to find out how clearly the ureter could be seen with ASP5354 during surgery in adults whose kidneys work properly or who have mild kidney problems. To do this, the surgeons injected ASP5354 into the person having surgery. Then, the surgeons compared images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light was the standard way surgeons see the ureter during surgery. People 12 years or older who were going to have certain abdominal surgeries could take part. Everyone taking part received ASP5354 during surgery, but how the imaging was done depended on which group they are in. Before surgery, the adults taking part whose kidneys work properly or who have mild kidney problems were assigned into 1 of 2 groups by chance alone. Images of the ureter were checked in 1 group using normal white light and the other group using normal white light and NIR-F. People 18 years and older with more severe kidney problems and all people under 18 years old were not be assigned to 1 of 2 groups: all images of the ureter were checked using normal white light and NIR-F. At the start of surgery, the surgeon injected ASP5354 into the person having surgery, then started recording a video. Then, after 30 minutes, the surgeon recorded how well the ureter could be seen. This was done by either using normal white light, or normal white light and NIR-F, depending which group each person having surgery was assigned to. For the group to be checked with normal white light and NIR-F, the surgeon did this every 30 minutes until the end of surgery. For the group to be checked with normal white light only, the surgeon did this after the first 30 minutes. During the study, people visited the study hospital 3 times. The first visit was to check if they can take part in the study. People were asked about their medical history, have had a medical examination, and their vital signs checked (blood pressure and pulse rate). Also, they had some blood and urine tests. For women and girls this may included a pregnancy test. People had their surgery at the second visit. This was within 28 days of their first visit. This included having some blood and urine tests before, during, and after surgery. Also, they had a medical examination, an electrocardiogram (ECG) to check their heart rhythm, and had their vital signs checked. After surgery, people returned to the clinic 15 days later for a final check-up. They were asked if they have had any medical problems. Also, they had a medical examination, had their vital signs checked, and had some blood and urine tests.

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