RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Randomized, Parallel Group Study to Investigate the Influence of Renal Impairment on the Efficacy and Safety of Two Doses of Bludigo™ (Indigotindisulfonate Sodium Injection, USP) 0.8% When Used as an Aid in the Determination of Ureteral Patency

Quick Facts

Study Start:2023-12-20

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06085183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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 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

Inclusion Criteria

Exclusion 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.
* 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 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

Contacts and Locations

Study Contact

Michelle Boytim, P.hD.

CONTACT

610-850-7115

michelle.boytim@provepharm.com

Study Locations (Sites)

Albany Medical Center

Albany, New York, 12008

United States

Collaborators and Investigators

Sponsor: Prove pharm

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Ureter Injury