3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency (UP)

Provepharm

Status and phase: Completed; Phase 3

Conditions: Ureter Injury

Treatments: Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Drug: Saline spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT04228445

PVP-19IC01

Details and patient eligibility

About

To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution for injection provides a visualization advantage compared to saline when used as an aid in the determination of ureteral patency

Full description

This is an open-label, randomized, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of two doses (2.5 mL and 5.0 mL) of 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium solution for injection when used as an aid in the determination of ureteral patency. Study will enroll up to 116 subjects from approximately 10 study centers in the United States.

Enrollment: 121 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects between ≥ 18 and ≤ 85 years old.
• Subjects who signed written, IRB approved, informed consent form.
• Subjects scheduled for urological or gynecological surgical procedures in which the patency of the ureter must be assessed by the surgeon during the procedure

Exclusion criteria

• Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only 1 kidney.
• Subjects with known severe hypersensitivity reactions to IC or other dyes including contrast agents.
• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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121 participants in 3 patient groups, including a placebo group

HIGH DOSE

Experimental group

Description:

48 subjects randomly treated with 5 mL of drug

Treatment:

Drug: Saline spray

Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%

LOW DOSE

Experimental group

Description:

48 subjects randomly treated with 2.5 mL of drug

Treatment:

Drug: Saline spray

Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%

Saline

Placebo Comparator group

Description:

96 subjects treated with 5 ml of saline than crossover to treatment arm

Treatment:

Drug: Saline spray