Completed

NCT Number: NCT05754333

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

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.

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Key information

Conditions

Intraoperative Ureter Visualization Abdominolpelvic Surgery

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AdventHealth Orlando, Orlando, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pudexacianinium chloride

Drug

Intravenous

Other names: ASP5354

Primary outcomes

Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Normal/Mild): WL/NIR-F]

Time frame: 30 minutes post dose (+/- 15 minutes)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.

Secondary outcomes

Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Normal/Mild): WL/NIR-F]

Time frame: WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Normal/Mild): WL/NIR-F]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F]

Time frame: From first dose every 30 minutes thereafter up to end of surgery (Day 1)

UC was quantified by image analysis when pudexacianinium was present in ureter. Contrast enhancement factor (CEF) was measure of degree to which color contrast (CC) was enhanced in areas in which drug fluorescence signal was present. Images of ureters during surgery were decomposed into red (R), green (G) & blue (B) using Image analysis software. R, G & B video components corresponding to each full color image were exported as 256 shades of gray, ranging from pure black (0) to pure white (255). CC between dye fluorescence in ureter & surrounding tissues was quantified by calculating ratio of signal levels G/(R + B). A higher CEF score=higher (green) contrast in ureter compared to the surrounding tissue. A commensurate ratio value was calculated for signals emanating from tissues surrounding ureter lumen. A comparison of ratio values was expressed as a CEF = (G/(R + B)inside)/(G/(R + B)outside. Overall average data of each time point from first dose up to end of surgery was reported.
Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F]

Time frame: 30 minutes post dose (+/- 15 minutes)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adolescent (Normal/Mild): WL/NIR-F]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]

Time frame: 30 minutes post dose (+/- 15 minutes)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]

Time frame: 30 minutes post dose (+/- 15 minutes)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter.
Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]

Time frame: WL and NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes

Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Difference in average index ureter conspicuity scores between NIR-F & WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 1, 2, 3 and 4 points higher.
Blinded Independent Central Reviewer (BICR) Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes (Adult (Normal/Mild): WL/NIR-F) and Concordance Correlation Coefficient (CCC) Between Investigator and BICR Reader

Time frame: 30 minutes post dose (+/- 15 minutes)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Concordance correlation coefficient (CCC) measures the agreement between investigator and BICR reader for the value difference between WL + NIR-F at 30 min timepoint. Results were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes is reported in Outcome measure #1.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Normal/Mild): WL/NIR-F] and CCC Between Investigator and BICR Reader

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. CCC is concordance correlation coefficient, & it measures agreement between investigator and BICR reader for value difference between WL at 30-mintimepoint & average of all NIR-F time points. Result were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints is reported in Outcome measure #2.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Normal/Mild): WL/NIR-F] and CCC Between Investigator and BICR Reader

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. CCC is concordance correlation coefficient, and it measures the agreement between investigator and BICR reader for the value difference between WL at 30-min timepoint and the end of surgery score under NIR-F. Results were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery is reported in Outcome measure #3.
BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F

Time frame: 30 minutes post dose (+/- 15 minutes)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adolescent (Normal/Mild): WL/NIR-F]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]

Time frame: 30 minutes post dose (+/- 15 minutes)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]

Time frame: 30 minutes post dose (+/- 15 minutes)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Time frame: From first dose up to 15 days (+ 10 days)

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily had a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether considered related to the IP. A TEAE was defined as an AE with onset at any time from first dosing until the follow up period. AEs were considered serious (SAEs) if the AE resulted, in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. TEAEs included both serious and Other (Not Including Serious) TEAE.
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration

Time frame: Day 1 Postdose: 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 390, 360 minutes

Concentration of pudexacianinium chloride in plasma. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint.
PK of Pudexacianinium Chloride: Urine Concentration

Time frame: Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes

Concentration of pudexacianinium chloride in urine.PK samples were collected up to the end of surgery timepoint of each participant. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint.
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)

Time frame: Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes

PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint.
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)

Time frame: Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes

PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Mar 3, 2023
Registry last updated: Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed