Actively Recruiting
An Open-Label, Randomized, Parallel Group Study to Investigate the Influence of Renal Impairment on the Efficacy and Safety of Two Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency
Led by Prove pharm · Updated on 2026-01-22
48
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two different doses (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8%, as a tool to help determine if the ureter is open in patients with varying levels of kidney function. This open-label, randomized, multicenter study includes adults aged 18 to 85 years with normal to severe renal impairment, grouped based on their estimated glomerular filtration rate (eGFR). Participants will be assigned to one of four kidney function groups and randomized to receive either a low dose (2.5 mL) or high dose (5.0 mL) of the study drug called Bludigo™. Before receiving Bludigo™, each participant will receive a saline injection to serve as a control. The study includes a screening period, baseline evaluations, a single treatment day with the study drug administered during surgery, and a 24-hour observation period after dosing. Participants will undergo screening procedures including medical history review, physical exam, lab tests, ECG, and vital sign checks. After surgery, researchers will assess ureteral patency using cystoscopy and measure outcomes such as urine jet visibility within 10 to 15 minutes after drug administration. Safety will be monitored through adverse event tracking, clinical labs, ECGs, and vital signs with follow-up visits up to 30 days after treatment to assess both safety and effectiveness outcomes.
CONDITIONS
Brief 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 218 and 285 years old
- Subjects who signed a written IRB approved, informed consent form
- Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure
- An estimated glomerular filtration rate (eGFR) at baseline determined using the Modification of Diet in Renal Disease formula (MDRD) and standardized by body surface area
- Subjects with normal renal function (eGFR 290 mL/min) judged to be in good health based on medical history, physical exam, vital signs, and lab safety tests
- Patients with mild, moderate, or severe chronic (more than 6 months), stable renal impairment with no acute episodes within the previous 2 months
You will not qualify if you...
- Subjects with eGFR less than 15 mL/min or expected need for dialysis soon, or having only one kidney
- Subjects with known severe hypersensitivity to Bludigo™ or other dyes including contrast dyes
- History of drug or alcohol abuse within 6 months prior to screening
- Conditions or diseases that make participation unsafe as assessed by the investigator
- Unable to meet protocol requirements or uncooperative with study procedures
- Investigator, sub-investigator, study staff or relatives involved in the study
- Subjects with life expectancy less than 6 months
- Requirement for treatments that could affect primary evaluation
- Pregnant or breastfeeding subjects
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days (Day -1 to Day 1)
Participants undergo baseline assessments and are evaluated for eligibility on the day of surgery. Eligible participants are randomized to receive either a high or low dose of Bludigo™ after an initial saline injection.
1 baseline visit (in-person)
Duration - 1 day (Day 1)
Participants receive a saline injection followed by a randomized dose of Bludigo™ during the surgical procedure with onsite observation for 24 hours post-dose.
1 treatment visit (in-person) with 24-hour observation
Duration - Up to 30 days post-treatment
Participants return for a follow-up visit between 7 and 30 days after the procedure and receive a final telephone follow-up call on Day 30 if the follow-up visit occurs before Day 28 to assess safety and recovery.
1 follow-up visit (in-person) and 1 telephone follow-up call
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.
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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