Study of Two Doses of Bludigo to Check Ureter Openness in Adults with Different Kidney Function Levels

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.

Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment