Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Rena… (NCT06085183) | Clinical Trial Compass
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
United States48 participantsStarted 2023-12-20
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 Bludigoâ„¢ or other dyes, including contrast dyes
* Known history of dru…