Using Indigotindisulfonate Sodium to Check Ureter Function in Patients with Kidney Issues
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™ When Used as an Aid in the Determination of Ureteral Patency
Run by Prove pharm · NCT06085183 · Data updated 2026-11-12
This study is testing if a new dye can help doctors check how well the ureters are working in people with kidney problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Prove pharm Industry-sponsored |
| Locations | 1 site (Albany, New York) |
| Status | Recruiting |
| Started | December 20, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06085183 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 with varying degrees of renal impairment scheduled for a surgical procedure requiring ureter assessment.
✕Probably not a fit
Patients with normal renal function who do not require ureteral assessment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized, multicenter study evaluates the efficacy and safety of two doses of Indigotindisulfonate Sodium Injection, USP 0.8% in determining ureteral patency in patients with varying degrees of renal impairment. Participants will be stratified into four cohorts based on their estimated glomerular filtration rate (eGFR) and will undergo a surgical procedure requiring cystoscopy to assess ureter function. The study will enroll approximately 48 subjects across multiple centers in the United States, with a comprehensive screening and evaluation process prior to treatment.
Why it matters
Potential benefit: If successful, this study could improve the assessment of ureteral function in patients with renal impairment, leading to better surgical outcomes.
How similar studies have gone: While this approach is novel in its specific application, similar studies have shown promise in evaluating renal function and ureteral patency.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Albany Medical Center
Albany, New York, United States Recruiting
Study contacts
- Study coordinator: Michelle Boytim, P.hD.
- Email: michelle.boytim@provepharm.com
- Phone: 610-850-7115
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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IS-001 injection helps see ureters during robot-assisted colorectal surgery
A intravenous injection of IS-001 is being tested to help surgeons visualize the ureters during robotic-assisted colectomy in patients with ureter injury risk.
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Comparing different flexible ureteroscopes for treating kidney stones
This study is testing which size of flexible ureteroscope works best for treating kidney stones in adults aged 18 to 80.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.