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

NCT06085183 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PVP-22IC05
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ureter Injury

Outcome Measures

Primary Outcomes (2)

• Paired sample difference (Bludigo - Saline) in urine jet conspicuity score.

  Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows: 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color Paired sample difference (Bludigo™-Saline) in conspicuity score (PSDCS). PSDCS will be calculated for each ureter (left or right) for each subject from each reviewer.

  10 to 15 minutes post study drug administration

• Responders to Bludigo

  Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows: 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color A subject is considered a responder to Bludigo™ if there is \>=1 point improvement in the conspicuity score following the Bludigo™- treatment vs the saline treatment and the conspicuity score for the Bludigo™ treatment must be (3, 4, or 5). The responder criteria will be assessed separately for each ureter (left or right) from each reviewer.

  10 to 15 minutes post study drug administration

Secondary Outcomes (9)

• Incidence of adverse events and serious adverse events.

  30 days post study drug administration

• Changes in clinical safety laboratory values

  30 days post study drug administration

• Changes in vital signs post treatment

  30 days post study drug administration

• Changes in ECG post treatment

  30 days post study drug administration

• Changes in blood pressure by dose group and Renal Impairment Cohort

  30 days post study drug administration

Other Outcomes (3)

• Difference between the Bludigo™ high dose vs Bludigo™ low dose in urine jet conspicuity score

  10 to 15 minutes post study drug administration

• Impact of renal impairment on renal elimination of Bludigo™

  12 hours post study drug administration

• Urinary excretion of Bludigo in patients with and without renal impairment

  12 hours post study drug administration

Study Arms (3)

Saline

PLACEBO COMPARATOR

48 subjects treated with 5 ml of saline then crossover to treatment arm

Other: Saline Injection 0.9%

High Dose

EXPERIMENTAL

24 subjects randomly treated with 5 mL of drug

Other: Saline Injection 0.9%; Drug: Indigotindisulfonate sodium 0.8%

Low Dose

EXPERIMENTAL

24 subjects randomly treated with 2.5 mL of drug

Other: Saline Injection 0.9%; Drug: Indigotindisulfonate sodium 0.8%

Interventions

Saline Injection 0.9% OTHER

Placebo

High Dose; Low Dose; Saline

Indigotindisulfonate sodium 0.8% DRUG

Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.

Also known as: Bludigo

High Dose; Low Dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prove pharm: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12008, United States

RECRUITING

Study Officials

• Michelle Boytim, Ph.D.

  Provepharm SAS

  STUDY DIRECTOR

Central Study Contacts

Michelle Boytim, P.hD.

CONTACT

610-850-7115; michelle.boytim@provepharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 16, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)