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

RecruitingPhase 4Ages 18 Years - 85 YearsAllProve pharm
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Subjects between โ‰ฅ 18 and โ‰ค 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 โ‰ฅ90 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 Bludigoโ„ข 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
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What it tests

  • Saline Injection 0.9%
  • Indigotindisulfonate sodium 0.8%
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Where

1 site
Albany Medical Center
Albany, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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