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

Launched by PROVE PHARM · Oct 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a special injection called Indigotindisulfonate Sodium Injection to see how effective and safe it is for checking if the ureters (the tubes that carry urine from the kidneys to the bladder) are open and functioning properly in patients with kidney problems. Researchers will compare two different doses of the injection to find out which one works best. The trial is open to adults aged 18 to 85 who are scheduled for surgery where the ureters need to be examined. Participants must have a specific level of kidney function, measured by a test called the estimated glomerular filtration rate (eGFR).

If you or a loved one qualifies, you can expect to sign an informed consent form agreeing to participate and will undergo some health checks, including a review of kidney function. The study is actively recruiting participants, meaning you could join now. It's important to know that those with severe kidney issues or certain health conditions won’t be eligible, and the researchers will ensure that the study is safe for all participants. This trial is a chance to contribute to medical research while receiving care related to your condition.

Gender

ALL

Eligibility 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