Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients

Launched by PROVE PHARM · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a dye called Bludigo® to help doctors see if the ureters, which are tubes that carry urine from the kidneys to the bladder, are open and functioning properly in children who are having surgery. The study is looking at how safe the dye is, how it works in the body, and how clearly it shows up during the procedure. The trial aims to enroll about 18 pediatric patients under the age of 17 from a few different hospitals in the U.S.

To participate, children must be scheduled for urological or gynecological surgery where checking the ureters is necessary. They will need their parent or guardian to sign consent forms to join. During the trial, participants will receive a dose of Bludigo® based on their weight, and doctors will observe and record how well the dye works for up to 10 minutes. After the procedure, kids will have a follow-up visit about two weeks later to check on their health and any potential side effects. It's important to note that there are specific health conditions that could prevent participation, including certain kidney issues or allergies to dyes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • I01. Patients from birth to \< 17 years
• • I02. Patients whose Parents or Legal Authorized Representative (LAR) have signed a written, IRB approved, informed consent form (ICF) and applicable assent obtained.
• • I03. Patients scheduled for urological or gynecological surgical procedures in which the patency of the ureters must be assessed by the surgeon during the surgery.
• Exclusion Criteria:
• • E01. For patients ≥ 1 year of age, Stage 5 Chronic Kidney Failure (defined as an eGFR (estimated glomerular filtration rate) ≤ 15mL/min/1.73 m2). (Calculated using the revised "Bedside Schwartz" equation (Schwartz et al. 2009) ). The revised "Bedside Schwartz" for eGFR is calculated as follows. eGFR (mL/min/1.73m2) = 0.413 \* height/Scr, where height is baseline height measured in cm and Scr is baseline serum creatine measured in mg/dL;
• • For patients less than 1 year of age, measured serum creatinine greater than 1.5-times the upper limit of normal (\>97.5 percentile) based on the reference table in Boer et al., 2010.
• • E02. Patients weighing less than 5 kgs.
• • E03. Patients with known severe hypersensitivity reactions to Bludigo® or other dyes including contrast agents.
• • E04. Patients with a history of, or being evaluated or treated for, gynecologic, renal, or urogenital (ureteral or bladder) cancer.
• • E05. Patients with known congenital cardiac conditions or who have a history of arrythmia, hypotension, hypertension, bradycardia or tachycardia.
• • E06. Patients, as assessed by the Investigator, with other conditions / concomitant diseases precluding their safe participation in this study (e.g., major systemic diseases).
• • E07. Unable to meet specific protocol requirements (e.g., scheduled visits), or has a condition that could lead to non-compliance with the study procedures or patient/parent/LAR uncooperative.
• • E08. Patient is the child of Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
• • E09. Patients with a life expectancy ≤ 6 months.
• • E10. Requirement for concomitant treatment with renal tubule transport inhibitors or with any treatment that could potentially discolor urine (see section 6.6)
• • E11. Patients who are pregnant or breast feeding.