Actively Recruiting
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Led by Prove pharm · Updated on 2026-01-22
48
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8% when used as an aid in the determination of ureteral patency in patients with different degrees of renal impairment.
CONDITIONS
Official Title
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects between 60 18 and 64 85 years old
- Signed informed consent form approved by IRB
- Scheduled for surgery requiring ureter patency assessment by cystoscopy
- Baseline kidney filtration rate (eGFR) measured using MDRD formula
- Normal renal function: eGFR 60 90 mL/min
- Mild renal impairment: eGFR 60 to 89 mL/min
- Moderate renal impairment: eGFR 30 to 59 mL/min
- Severe renal impairment: eGFR 15 to 29 mL/min
- Normal renal function subjects judged healthy based on medical history, physical exam, vital signs, and lab tests
- Patients with chronic, stable renal insufficiency for more than 6 months
You will not qualify if you...
- eGFR less than 15 mL/min or expected need for dialysis soon, or having only one kidney
- Known severe allergic reactions to Bludigo2 or other contrast dyes
- History of drug or alcohol abuse within 6 months before screening
- Conditions or diseases making participation unsafe as judged by investigator
- Unable or unwilling to comply with study procedures
- Investigator, study staff, or relatives directly involved in the study
- Life expectancy less than 6 months
- Need for treatments that could affect study results
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Albany Medical Center
Albany, New York, United States, 12008
Actively Recruiting
Research Team
M
Michelle Boytim, P.hD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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