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NCT05999747RECRUITINGIRB Ready

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

Sponsored by Astellas Pharma Global Development, Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 94 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

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 โ‰ฅ 60 mL/min
Adult moderate/severe eGFR cohort: eGFR โ‰ฅ 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
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 participan

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

94 participants

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Gender

ALL

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Sponsor

Astellas Pharma Global Development, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Los Angeles

California

Location available
View Los Angeles location page
Unknown

Newport Beach

California

Location available
View Newport Beach location page
Unknown

Tampa

Florida

Location available
View Tampa location page
Unknown

Weston

Florida

Location available
View Weston location page
Unknown

St Louis

Missouri

Location available
View St Louis location page
Unknown

Las Vegas

Nevada

Location available
View Las Vegas location page
Unknown

Durham

North Carolina

Location available
View Durham location page
Unknown

Pinehurst

North Carolina

Location available
View Pinehurst location page
Unknown

Philadelphia

Pennsylvania

Location available
View Philadelphia location page

๐Ÿ“ And 3 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Kidney Disease Treatment in Newport Beach?

Join others in California exploring innovative treatment options through clinical research

Kidney Disease Treatment Options in Newport Beach, California

If you're searching for Kidney Disease treatment in Newport Beach, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Newport Beach, Tampa, Weston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Kidney Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 94 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Kidney Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Kidney Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Kidney Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05999747. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.