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White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment for Intraoperative Ureteroscopy

Q: Are participants being actively sought for this ongoing research study?

Based on information from clinicaltrials.gov, this current research study is actively enrolling volunteers. The initial posting was made on February 28th, 2024 and the most recent update occurred on April 2nd of the same year.

Q: What is the upper limit for the number of participants enrolled in this clinical investigation?

Indeed, the details available on clinicaltrials.gov specify that this particular medical investigation is actively enrolling volunteers. The trial was initially uploaded on February 28th, 2024 and underwent its most recent revision on April 2nd, 2024. Recruitment aims to secure 94 participants from a sole location.

Q: What are the potential risks of using White Light/near-infrared fluorescence in adult patients with normal kidney function or slight kidney impairment?

Our team at Power assesses the safety of White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment as a 3 on our scale, denoting significant support from efficacy data and extensive safety data due to its Phase 3 trial status.

Phase 3

Recruiting

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45 minutes after asp5354 administration (day 1)

Awards & highlights

Study Summary

This trial is testing a new medical dye called ASP5354 that can help surgeons see the ureter more clearly during abdominal surgery. The dye is injected into the patient at the start of surgery and is

Who is the study for?

This trial is for adults needing certain abdominal surgeries, with normal or mildly impaired kidney function (eGFR ≥ 60 mL/min) or moderate to severe impairment (eGFR ≥ 15 to < 60 mL/min). Women must not be pregnant, breastfeeding, or donating eggs and agree to use contraception. Men must not donate sperm and if their partner can bear children, they should use contraception.Check my eligibility

What is being tested?

The study tests a new medical dye called ASP5354 designed to help surgeons see the ureter more clearly during surgery using near infrared fluorescence imaging. Participants will receive the dye and have their ureters imaged with standard white light and/or NIR-F technology depending on their group assignment.See study design

What are the potential side effects?

Potential side effects of ASP5354 are not detailed in the provided information but may include reactions at the injection site, allergic responses, or interference with kidney function especially in those who already have kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 45 minutes after asp5354 administration (day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 45 minutes after asp5354 administration (day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 minutes after asp5354 administration (day 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intra-participant comparison in ureter conspicuity for white light (WL) versus near -infrared fluorescence (NIR F) for participants with normal renal function or mild renal impairment.

Secondary outcome measures

Inter-rater reliability between the surgeons and BICR for the WL versus NIR-F for participants with normal renal function or mild renal impairment

Inter-rater reliability between the surgeons and BICR for the WL versus the average of all NIR-F time points for participants with normal renal function or mild renal impairment

Inter-rater reliability between the surgeons and BICR for the WL versus the end of surgery time point score with NIR-F for participants with normal renal function or mild renal impairment

+26 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairmentExperimental Treatment1 Intervention

Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354

Group II: White Light/near-infrared fluorescence - Adults with moderate or severe renal impairmentExperimental Treatment1 Intervention

Adult participants with moderate or severe renal impairment will receive a single dose of ASP5354

Group III: White Light - Adults with normal renal function or mild renal impairmentExperimental Treatment1 Intervention

Adult participants with normal renal function or mild renal impairment will receive a single dose of ASP5354

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pudexacianinium chloride

2022

Completed Phase 1

~30

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor

192 Previous Clinical Trials

120,992 Total Patients Enrolled

Medical MonitorStudy DirectorAstellas Pharma Global Development, Inc.

1,660 Previous Clinical Trials

983,735 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively sought for this ongoing research study?

"Based on information from clinicaltrials.gov, this current research study is actively enrolling volunteers. The initial posting was made on February 28th, 2024 and the most recent update occurred on April 2nd of the same year."

Answered by AI

What is the upper limit for the number of participants enrolled in this clinical investigation?

"Indeed, the details available on clinicaltrials.gov specify that this particular medical investigation is actively enrolling volunteers. The trial was initially uploaded on February 28th, 2024 and underwent its most recent revision on April 2nd, 2024. Recruitment aims to secure 94 participants from a sole location."

Answered by AI

What are the potential risks of using White Light/near-infrared fluorescence in adult patients with normal kidney function or slight kidney impairment?

"Our team at Power assesses the safety of White Light/near-infrared fluorescence - Adults with normal renal function or mild renal impairment as a 3 on our scale, denoting significant support from efficacy data and extensive safety data due to its Phase 3 trial status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease

2024. "A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05999747.

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