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pudexacianinium chloride for Kidney Failure

Phase 1
Waitlist Available
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 up to 12 days
Awards & highlights

Study Summary

This trial is testing a new medical dye, ASP5354, to see if it is safe for humans and if it can help surgeons see the ureter during abdominal surgery.

Eligible Conditions
  • Kidney Failure
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK of ASP5354 in plasma: apparent clearance (CL)
PK of ASP5354 in plasma: area under concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
PK of ASP5354 in plasma: maximum concentration (Cmax)
+6 more
Secondary outcome measures
Number of participants with Adverse Events (AEs)
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with laboratory value abnomalities and/or AEs
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Severe renal impairmentExperimental Treatment1 Intervention
Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.
Group II: Normal renal functionExperimental Treatment1 Intervention
Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.
Group III: Moderate renal impairmentExperimental Treatment1 Intervention
Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.
Group IV: Mild renal impairmentExperimental Treatment1 Intervention
Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pudexacianinium chloride
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,034 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,458 Total Patients Enrolled

Frequently Asked Questions

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

Does this research investigate the effects on individuals over a certain age?

"According to the study's admission standards, participants must be between 18 and 75 years old. There are 56 studies available for minors while older patients have access to 523 trials."

Answered by AI

How many individuals are currently receiving treatment through this clinical research?

"Affirmative. As documented on clinicaltrials.gov, this trial is presently recruiting patients who are willing to partake in the study. The initial posting was made on August 25th 2022 and it has been updated as recently as November 14th 2022. 36 individuals will be accepted across 3 sites for participation."

Answered by AI

What potential risks could a patient encounter when being treated with pudexacianinium chloride?

"Our team at Power has assigned pudexacianinium chloride a score of 1 due to the fact that this medication is currently in its first trial phase, indicating limited evidence exists for both efficacy and safety."

Answered by AI

Is enrollment still possible for this clinical trial?

"Yes, this experiment is presently recruiting. According to clinicaltrials.gov, the trial was launched on August 25th 2022 and most recently modified on November 14th of that same year. It requires 36 participants from 3 medical facilities for completion."

Answered by AI

What criteria must I meet to participate in this research?

"This clinical trial seeks 36 individuals with a healthy BMI range of 17.6 to 30 kg/m^2 and weighing at least 50 kilograms (for male participants) or 40 kilograms (for female). In particular, Women Of Childbearing Potential must agree to contraceptive methods while the study is in progress and for 30 days after its conclusion; additionally, they may not donate ova during this period. Meanwhile, men are prohibited from donating sperm throughout the treatment and post-treatment phases as well as engaging in sexual activities that could result in pregnancy with their partner(s), who must also use contraception over these timespans. Moreover, all candidates"

Answered by AI

What is the ultimate objective of this research endeavor?

"This trial's primary objective is to quantify the absorption, distribution, metabolism and excretion (PK) of ASP5354 in urine over a duration of up to three days. Secondary goals include assessing any adverse events related to participant vital signs, laboratory values or electrocardiograms."

Answered by AI

Who else is applying?

What site did they apply to?
Orange County Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What state do they live in?
California

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Orange County Research Center: < 48 hours
Average response time
  • < 2 Days
~10 spots leftby Apr 2025