Intraoperative Ureter VisualizationPhase 3NCT05999747
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease
A Phase 3 study testing pudexacianinium chloride in people with Intraoperative Ureter Visualization and Abdominolpelvic Surgery, run by Astellas Pharma Global Development, Inc. at 12 sites in United States.
Trial 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, although rare, could be serious. This study is about a potential new medical dye, called ASP5354. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Ureter Visualization, Abdominolpelvic Surgery
- What is being tested?
- pudexacianinium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Mar 2024to 13 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Duke University Hospital
Durham, North Carolina, 27705
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
University of Nevada, Las Vegas
Las Vegas, Nevada, 89102
Cedars Sinai Medical Center
Los Angeles, California, 90048
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Firsthealth of the Carolinas INC
Pinehurst, North Carolina, 28374
Benaroya Research Institute at VA Mason
Seattle, Washington, 98101
Washington University Center
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official 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 Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
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.
This study is about a potential new medical dye, called ASP5354. This dye is injected into the person at the start of surgery and is detected in the ureter. This is done by an imaging machine which has an option called near infrared fluorescence, or NIR-F. Together they show live images of specific parts of the body. In this study, ASP5354 is used with an imaging machine with a NIR-F option to show live images of the ureter during surgery.
Read more
People with kidneys that work properly and those with kidney problems can take part in this study. The main goal of the study is to find out how clearly the ureter can be seen with ASP5354 during surgery in people whose kidneys work properly or who have mild kidney problems. To do this, the surgeons will inject ASP5354 into the person having surgery. Then, the surgeons will compare images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light is the standard way surgeons see the ureter during surgery.
People 18 years or older, with or without kidney disease, who were going to have certain abdominal surgeries may be able to take part.
Everyone taking part will receive ASP5354 during surgery, but how the imaging is done will depend on which group they are in. Before surgery, the people whose kidneys work properly or who have mild kidney problems will be assigned into 1 of 2 groups by chance alone. Images of the ureter will be checked in 1 group using normal white light and the other group using normal white light and NIR-F. People with more severe kidney problems will not be assigned to 1 of 2 groups: all images of the ureter will be checked using normal white light and NIR-F.
At the start of surgery, the surgeon will inject ASP5354 into the person having surgery, then will start recording a video of the surgery. Then, after 30 minutes, the surgeon will record how well the ureter can be seen. This will be done by either using normal white light, or normal white light and NIR-F, depending on which group each person having surgery is assigned. For the group to be checked with normal white light and NIR-F, the surgeon will do this check every 30 minutes until the end of surgery. For the group to be checked with normal white light only, the surgeon will only do this check after the first 30 minutes. A group of medical experts will also record how well the ureter can be seen in the surgery videos. The medical experts will not be directly involved in this study. They won't know who the images belong to or which group they are from.
During the study, people will visit the study hospital 3 times. The first visit is to check if they can take part in the study. People will be asked about their medical history, have a medical examination, and their vital signs checked (blood pressure and pulse rate). Also, they will have some blood and urine tests. For women this may include a pregnancy test. People will have their surgery at the second visit. This will be within 28 days or 56 days of their first visit, depending on how severe their kidney problems are. This includes having some blood and urine tests before, during, and after surgery. Also, they will have a medical examination, an electrocardiogram (ECG) to check their heart rhythm, and have their vital signs checked. After surgery, people will return to the clinic 10 days later for a final check-up. They will be asked if they have had any medical problems. Also, they will have a medical examination, have their vital signs checked, and have blood and urine tests.
- Being tested
- pudexacianinium chloride
- Keywords
- ASP5354, Pudexacianinium chloride, Latrogenic ureteral injury, Abdominopelvic surgery, Near-infrared Fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pudexacianinium chlorideDrug
Also called ASP5354
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment | Experimental | Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354 Receives: Drug: pudexacianinium chloride |
| White Light - Adults with normal renal function or mild renal impairment | Experimental | Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354 Receives: Drug: pudexacianinium chloride |
| White Light/near-infrared fluorescence - Adults with moderate or severe renal impairment | Experimental | Adult participants with moderate or severe renal impairment will receive a single dose of ASP5354 Receives: Drug: pudexacianinium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-participant comparison in ureter conspicuity for white light (WL) versus near -infrared fluorescence (NIR F) at the first time point for participants with normal renal function or mild renal impairment.
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Secondary outcomes (38)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from1 (None) to 5 (Excellent)
Measured: Up to end of surgery (Day1)
Intra-participant comparison of ureter conspicuity scores for WL timepoint versus the end of surgery score with NIR-F for participants with normal renal function or mild renal impairment
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to end of surgery (Day1)
Quantification of ureter conspicuity for WL and NIR-F illumination modes for all participants
Ureter conspicuity will be quantified by image analysis measuring the color contrast when ASP5354 is present in the ureter.
Measured: Up to end of surgery (Day1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants with moderate or severe renal impairment
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant comparison of ureter conspicuity scores for WL at the first time point versus the average of all NIR-F scores for participants with moderate or severe renal impairment
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to end of surgery (Day1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the end of surgery scores with NIR-F for participants with moderate or severe renal impairment
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to end of surgery (Day1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants in all cohorts
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants in all cohorts
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to end of surgery (Day1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the end of surgery score with NIR-F for participants in all cohorts
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to end of surgery (Day1)
Percentage of participants with an average index ureter conspicuity over all NIR-F time points at least 1 point higher than the average index ureter conspicuity over all WL time points
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Number of participants with an average index ureter conspicuity over all NIR-F time points at least 1 point higher than the average index ureter conspicuity over all WL time points
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Percentage of participants with an average index ureter conspicuity over all NIR-F time points at least 2, 3 or 4 points higher than the average index ureter conspicuity over all WL time points
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Number of participants with an average index ureter conspicuity over all NIR-F time points at least 2, 3 or 4 points higher than the average index ureter conspicuity over all WL time points
Conspicuity will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Number of participants with Treatment-emergent adverse events (TEAEs)
Adverse events (AEs) will be coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as an AE observed after administration of the study intervention and up to the follow-up period.
Measured: Up to Day 25
Number of participants with serious TEAEs
A Serious Adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event. A serious TEAE is defined as an SAE observed after administration of the study intervention and up to the follow-up period.
Measured: Up to Day 25
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values
Measured: Up to Day 25
Number of participants with vital sign abnormalities and/or AEs
Number of participants potentially clinically significant vital signs
Measured: Up to Day 25
Number of participants with electrocardiogram (ECG) /cardiac monitoring abnormalities and/or AEs
Number of participants potentially clinically significant ECGs/cardiac monitoring
Measured: Up to Day 2
Pharmacokinetics (PK) of ASP5354 in plasma: concentration
Concentration will be recorded from the PK plasma samples collected
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Pharmacokinetics (PK) of ASP5354 in plasma: concentration
Concentration will be recorded from the PK plasma samples collected
Measured: Up to the end of surgery (Day 1)
PK of ASP5354 in urine: concentration
Concentration will be recorded from the PK urine samples collected
Measured: Up to end of surgery (Day 1)
PK of ASP5354 in urine: amount of ASP5354 excreted in urine (Ae)
Ae will be recorded from the PK urine samples collected
Measured: Up to end of surgery (Day1)
PK of ASP5354 in urine: percentage of ASP5354 dose excreted into urine (Ae percentage)
Ae percentage will be recorded from the PK urine samples collected
Measured: Up to end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants with normal renal function or mild renal impairment
BICR's (blinded independent central review) conspicuity assessment of the ureter will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the end of surgery time point score with NIR-F for adults with normal renal function or mild renal impairment
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants with moderate or severe renal impairment
BICR's conspicuity assessment of the ureter at the first time point will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to 45 minutes after ASP5343 administration (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants with moderate or severe renal impairment
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the end of surgery time point score with NIR F for participants with moderate or severe renal impairment
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for all participants in all cohorts
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants in all cohorts
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the end of surgery time point score with NIR F for participants in all cohorts
BICR's conspicuity assessment of the ureter when using ASP5354 with NIR-F for the duration of the surgical procedure will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point by each BICR reader for participants with normal renal function or mild renal impairment
BICR's conspicuity assessment of the ureter will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Concordance Correlation Coefficient (CCC), the inter-rater reliability between the investigators and BICR for the WL versus NIR-F at the first time point for participants with normal renal function or mild renal impairment
Determine degree of concordance between investigator's intra-operative conspicuity assessment of the ureter and BICR assessment
Measured: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant difference in ureter conspicuity for WL at the first time point versus the average of all NIR-F time points by each BICR reader for participants with normal renal function or mild renal impairment
BICR's conspicuity assessment of the ureter will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
CCC, the inter-rater reliability between the investigators and BICR for the WL at the first timepoint versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment
Determine degree of concordance between investigator's intra-operative conspicuity assessment of the ureter and BICR assessment
Measured: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL at the first time point versus the end of surgery time point score with NIR-F by each BICR reader for participants with normal renal function or mild renal impairment
BICR's conspicuity assessment of the ureter will be scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
Measured: Up to the end of surgery (Day 1)
CCC, inter-rater reliability between the investigators and BICR for the WL at the first time point versus the end of surgery time point score with NIR-F for participants with normal renal function or mild renal impairment
Determine degree of concordance between investigator's intra-operative conspicuity assessment of the ureter and BICR assessment
Measured: Up to the end of surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start19 Mar 2024
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Ureter VisualizationStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999747
- Sponsor's protocol ID
- 5354-CL-0303
- Status last verified
- Oct 2025
- First submitted
- 14 Aug 2023
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
- ClinicalTrials.gov ID
- NCT05999747
- Acronym / sponsor ID
- 5354-CL-0303
- Keywords
- ASP5354, Pudexacianinium chloride, Latrogenic ureteral injury, Abdominopelvic surgery, Near-infrared Fluorescence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
This study is about a potential new medical dye, called ASP5354. This dye is injected into the person at the start of surgery and is detected in the ureter. This is done by an imaging machine which has an option called near infrared fluorescence, or NIR-F. Together they show live images of specific parts of the body. In this study, ASP5354 is 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 can take part in this study. The main goal of the study is to find out how clearly the ureter can be seen with ASP5354 during surgery in people whose kidneys work properly or who have mild kidney problems. To do this, the surgeons will inject ASP5354 into the person having surgery. Then, the surgeons will compare images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light is the standard way surgeons see the ureter during surgery.
People 18 years or older, with or without kidney disease, who were going to have certain abdominal surgeries may be able to take part.
Everyone taking part will receive ASP5354 during surgery, but how the imaging is done will depend on which group they are in. Before surgery, the people whose kidneys work properly or who have mild kidney problems will be assigned into 1 of 2 groups by chance alone. Images of the ureter will be checked in 1 group using normal white light and the other group using normal white light and NIR-F. People with more severe kidney problems will not be assigned to 1 of 2 groups: all images of the ureter will be checked using normal white light and NIR-F.
At the start of surgery, the surgeon will inject ASP5354 into the person having surgery, then will start recording a video of the surgery. Then, after 30 minutes, the surgeon will record how well the ureter can be seen. This will be done by either using normal white light, or normal white light and NIR-F, depending on which group each person having surgery is assigned. For the group to be checked with normal white light and NIR-F, the surgeon will do this check every 30 minutes until the end of surgery. For the group to be checked with normal white light only, the surgeon will only do this check after the first 30 minutes. A group of medical experts will also record how well the ureter can be seen in the surgery videos. The medical experts will not be directly involved in this study. They won't know who the images belong to or which group they are from.
During the study, people will visit the study hospital 3 times. The first visit is to check if they can take part in the study. People will be asked about their medical history, have a medical examination, and their vital signs checked (blood pressure and pulse rate). Also, they will have some blood and urine tests. For women this may include a pregnancy test. People will have their surgery at the second visit. This will be within 28 days or 56 days of their first visit, depending on how severe their kidney problems are. This includes having some blood and urine tests before, during, and after surgery. Also, they will have a medical examination, an electrocardiogram (ECG) to check their heart rhythm, and have their vital signs checked. After surgery, people will return to the clinic 10 days later for a final check-up. They will be asked if they have had any medical problems. Also, they will have a medical examination, have their vital signs checked, and have blood and urine tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment | Experimental | Drug: pudexacianinium chlorideAdult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354 |
| White Light - Adults with normal renal function or mild renal impairment | Experimental | Drug: pudexacianinium chlorideAdult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354 |
| White Light/near-infrared fluorescence - Adults with moderate or severe renal impairment | Experimental | Drug: pudexacianinium chlorideAdult participants with moderate or severe renal impairment will receive a single dose of ASP5354 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Female participant is not pregnant and at least 1 of the following conditions apply:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pudexacianinium chlorideAlso: ASP5354Intravenous | Drug | White Light - Adults with normal renal function or mild renal impairment, White Light/near-infrared fluorescence - Adults with moderate or severe renal impairment, White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment |
Primary outcome
Intra-participant comparison in ureter conspicuity for white light (WL) versus near -infrared fluorescence (NIR F) at the first time point for participants with normal renal function or mild renal impairment.
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Conspicuity will be scored individually for each illumination mode using the 5-Point Likert Scale, ranging from 1 (None) to 5 (Excellent)
38 secondary outcomes
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment
Time frame: Up to end of surgery (Day1)
Intra-participant comparison of ureter conspicuity scores for WL timepoint versus the end of surgery score with NIR-F for participants with normal renal function or mild renal impairment
Time frame: Up to end of surgery (Day1)
Quantification of ureter conspicuity for WL and NIR-F illumination modes for all participants
Time frame: Up to end of surgery (Day1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants with moderate or severe renal impairment
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant comparison of ureter conspicuity scores for WL at the first time point versus the average of all NIR-F scores for participants with moderate or severe renal impairment
Time frame: Up to end of surgery (Day1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the end of surgery scores with NIR-F for participants with moderate or severe renal impairment
Time frame: Up to end of surgery (Day1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants in all cohorts
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants in all cohorts
Time frame: Up to end of surgery (Day1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the end of surgery score with NIR-F for participants in all cohorts
Time frame: Up to end of surgery (Day1)
Percentage of participants with an average index ureter conspicuity over all NIR-F time points at least 1 point higher than the average index ureter conspicuity over all WL time points
Time frame: Up to the end of surgery (Day 1)
Number of participants with an average index ureter conspicuity over all NIR-F time points at least 1 point higher than the average index ureter conspicuity over all WL time points
Time frame: Up to the end of surgery (Day 1)
Percentage of participants with an average index ureter conspicuity over all NIR-F time points at least 2, 3 or 4 points higher than the average index ureter conspicuity over all WL time points
Time frame: Up to the end of surgery (Day 1)
Number of participants with an average index ureter conspicuity over all NIR-F time points at least 2, 3 or 4 points higher than the average index ureter conspicuity over all WL time points
Time frame: Up to the end of surgery (Day 1)
Number of participants with Treatment-emergent adverse events (TEAEs)
Time frame: Up to Day 25
Number of participants with serious TEAEs
Time frame: Up to Day 25
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to Day 25
Number of participants with vital sign abnormalities and/or AEs
Time frame: Up to Day 25
Number of participants with electrocardiogram (ECG) /cardiac monitoring abnormalities and/or AEs
Time frame: Up to Day 2
Pharmacokinetics (PK) of ASP5354 in plasma: concentration
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Pharmacokinetics (PK) of ASP5354 in plasma: concentration
Time frame: Up to the end of surgery (Day 1)
PK of ASP5354 in urine: concentration
Time frame: Up to end of surgery (Day 1)
PK of ASP5354 in urine: amount of ASP5354 excreted in urine (Ae)
Time frame: Up to end of surgery (Day1)
PK of ASP5354 in urine: percentage of ASP5354 dose excreted into urine (Ae percentage)
Time frame: Up to end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants with normal renal function or mild renal impairment
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment
Time frame: Up to the end of surgery (Day 1)
Intra-participant comparison of ureter conspicuity scores for the WL at the first time point versus the end of surgery time point score with NIR-F for adults with normal renal function or mild renal impairment
Time frame: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for participants with moderate or severe renal impairment
Time frame: Up to 45 minutes after ASP5343 administration (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants with moderate or severe renal impairment
Time frame: Up to the end of surgery (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the end of surgery time point score with NIR F for participants with moderate or severe renal impairment
Time frame: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point for all participants in all cohorts
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the average of all NIR-F time points for participants in all cohorts
Time frame: Up to the end of surgery (Day 1)
Ureter conspicuity scores for the WL at the first time point versus the end of surgery time point score with NIR F for participants in all cohorts
Time frame: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL versus NIR-F at the first time point by each BICR reader for participants with normal renal function or mild renal impairment
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Concordance Correlation Coefficient (CCC), the inter-rater reliability between the investigators and BICR for the WL versus NIR-F at the first time point for participants with normal renal function or mild renal impairment
Time frame: Up to 45 minutes after ASP5354 administration (Day 1)
Intra-participant difference in ureter conspicuity for WL at the first time point versus the average of all NIR-F time points by each BICR reader for participants with normal renal function or mild renal impairment
Time frame: Up to the end of surgery (Day 1)
CCC, the inter-rater reliability between the investigators and BICR for the WL at the first timepoint versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment
Time frame: Up to the end of surgery (Day 1)
Intra-participant difference in ureter conspicuity for WL at the first time point versus the end of surgery time point score with NIR-F by each BICR reader for participants with normal renal function or mild renal impairment
Time frame: Up to the end of surgery (Day 1)
CCC, inter-rater reliability between the investigators and BICR for the WL at the first time point versus the end of surgery time point score with NIR-F for participants with normal renal function or mild renal impairment
Time frame: Up to the end of surgery (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Intraoperative Ureter Visualization
Active, not recruitingPhase 1
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
Ureter Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Astellas Pharma Global Development, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pudexacianinium chloride in people with Intraoperative Ureter Visualization and Abdominolpelvic Surgery, run by Astellas Pharma Global Development, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-participant comparison in ureter conspicuity for white light (WL) versus near -infrared fluorescence (NIR F) at the first time point for participants with normal renal function or mild renal impairment. (time frame: Up to 45 minutes after ASP5354 administration (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.