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

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prove pharm

Criteria

Inclusion Criteria:

• Subjects between ≥ 18 and ≤ 85 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 will be determined using the Modification of Diet in Renal Disease formula (MDRD) and standardized by using individual's body surface area.

Subject's renal function will be defined based on the following criteria:

• Normal subjects: eGFR of ≥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

Subjects with normal renal function that are judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the Screening Visit and/or prior to administration of study drug.

Patients with renal impairment (mild, moderate, or severe) who have a diagnosis of chronic (>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in renal function) renal insufficiency meeting criteria at the Screening Visit

Exclusion Criteria:

• Subjects with eGFR <15 mL/min or expected need for dialysis in the near future, or having only 1 kidney

• Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes

• Known history of drug or alcohol abuse within 6 months prior to the time of screening visit

• Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g., major systemic diseases)

• Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures

• Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

• Subjects with life expectancy < 6 months

• Requirement for concomitant treatment that could bias primary evaluation.

• Subjects who are pregnant or breast-feeding