Medical Dye for Ureter Visualization During Surgery

No longer recruiting at 5 trial locations

Overseen By Astellas Pharma Global Development Inc.

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: Antibiotics, NIR-F agents

Disqualifiers: Ureteral stenting, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medical dye, ASP5354 (Pudexacianinium chloride), to help surgeons see the ureter more clearly during abdominal surgeries. The ureter, which carries urine from the kidneys to the bladder, can be difficult to see during surgery, risking accidental injury. The dye will be used with a special imaging machine that provides a live view of the ureter. Individuals aged 12 or older undergoing certain abdominal surgeries, with kidneys functioning normally or with mild issues, might qualify for this trial. Participants will receive the dye during surgery, and the visibility of the ureter will be compared using regular light and near-infrared fluorescence, a special imaging technique. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking medical advancement.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that ASP5354, also known as pudexacianinium chloride, helps surgeons see the ureter more clearly during surgery. Evidence from previous studies indicates that doses up to 24 mg are generally well-tolerated. Participants did not report any serious side effects, suggesting it is safe for use during surgery.

Earlier research also examined ASP5354's safety and effectiveness in making the ureter visible. Participants handled it well, with no major problems. While minor side effects can occur, these studies support that ASP5354 is safe for helping surgeons avoid injuring the ureter during procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the treatments using ASP5354 because they offer a new way to visualize the ureters during surgery. Unlike the standard white light method, ASP5354 employs a dye called pudexacianinium chloride, which is enhanced by near-infrared fluorescence. This allows surgeons to see the ureters with greater clarity and precision, potentially reducing surgical errors. By improving visualization, this technique could make surgeries safer and more effective for patients with different levels of renal function.

What evidence suggests that this medical dye is effective for ureter visualization during surgery?

Research shows that ASP5354, also known as pudexacianinium chloride, helps surgeons see the ureter more clearly during surgery. The ureter is the tube that carries urine from the kidneys to the bladder. Studies have found that this dye, when used with a special imaging machine, allows surgeons to identify the ureter more accurately than traditional methods. In one study, the ureter became visible just 30 minutes after administering ASP5354. This improved visibility is crucial because it helps prevent accidental injury to the ureter, which can be serious. In this trial, participants will receive ASP5354, and the treatment is designed to work for people with different levels of kidney function, making it suitable for those with healthy kidneys as well as those with mild or moderate kidney issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Medical Monitor

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older who are scheduled for certain abdominopelvic surgeries where identifying the ureter is necessary. Participants must have normal to mild kidney issues, measured by eGFR. Women must not be pregnant or breastfeeding and agree to contraception guidelines. Men with partners of childbearing potential must also follow contraceptive rules.

Inclusion Criteria

Participant (and/or participant's parent or legal guardian) agrees not to participate in another interventional study while participating in the present study

I am a man who agrees to use birth control with my partner who can have children.

I am scheduled for a surgery in my abdomen or pelvis where they might need to find my ureters.

Exclusion Criteria

Participant has any physical or psychiatric condition which makes the participant unsuitable for study participation

I am currently being treated for a urinary tract infection.

My body weight is less than 30 kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Treatment

Participants receive ASP5354 during surgery for ureter visualization using NIR-F imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

15 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ASP5354

Trial Overview The study tests a new medical dye called ASP5354, used during surgery to make the ureter visible under near infrared fluorescence (NIR-F) imaging. Participants will receive this dye; their ureters will then be observed using standard white light or NIR-F imaging based on random group assignment.

How Is the Trial Designed?

Group I: Adult (Normal/Mild): White Light/near-infrared fluorescence Experimental Treatment 1 Intervention

Adults participants with with normal renal function or mild renal impairment received a single IV 3 mg dose (3 vials of 1 mg) of pudexacianinium chloride administered approximately 30 (± 15) min before ureter visualization, on day 1. WL and NIR-F were used to recognize/identify the ureter.

Group II: Adult (Normal/Mild): White Light only Experimental Treatment 1 Intervention

Adults participants with normal renal function or mild renal impairment received a single IV 3 mg dose (3 vials of 1 mg) of pudexacianinium chloride approximately 30 (± 15) min before the ureter visualization, on day 1. WL was used to recognize/identify the ureter.

Group III: Adult (Moderate): White Light/near-infrared fluorescence Experimental Treatment 1 Intervention

Adults participants with moderate renal impairment received a single IV 3 mg dose (3 vial of 1 mg) of pudexacianinium chloride approximately 30 (± 15) min before ureter visualization, on day 1. WL and NIR-F were used to recognize/identify the ureter.

Group IV: Adolescent (Normal/Mild): White Light/near-infrared fluorescence Experimental Treatment 1 Intervention

Adolescents participants with normal renal function or mild renal impairment renal impairment received a single IV 3 mg dose (3 vials of 1 mg) of pudexacianinium chloride approximately 30 (± 15) min before ureter visualization, on day 1. WL and NIR-F were used to recognize/identify the ureter.

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10462524/

Pudexacianinium (ASP5354) chloride for ureter visualization ... A correlation was observed between qualitative (surgeon's recognition/identification of the ureter during surgery) and quantitative (video ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04238481

A Study for Ureter Visualization, Using ASP5354 in ... The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37474823/

Pudexacianinium (ASP5354) chloride for ureter ... The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after pudexacianinium ...

4. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.1354

Population Pharmacokinetic Modeling and Simulation of ... Pudexacianinium (ASP5354) chloride is an indocyanine green derivative designed to enable enhanced ureter visualization during surgery.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05999747

NCT05999747 | A Study to Find Out if ASP5354 Can ... 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 ...

6. link.springer.com link.springer.com/article/10.1007/s00464-023-10193-9

Pudexacianinium (ASP5354) chloride for ureter ... Secondary objectives were to investigate the safety, tolerability, and PK of pudexacianinium; corresponding secondary endpoints included adverse ...

7. clinicaltrials.astellas.com clinicaltrials.astellas.com/study/5354-CL-0301

A study to find out if ASP5354 can clearly help show ... 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 ...

8. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.1013

Randomized, Double‐Blind, Controlled Study to Evaluate ... These results support further evaluation of ASP5354 at doses up to 24 mg for intraoperative near-infrared fluorescence ureter visualization.