Injekce indigotindisulfonátu sodného, USP jako pomůcka při určování průchodnosti močovodů u pacientů s poruchou ledvin
Otevřená, randomizovaná, paralelní skupinová studie ke zkoumání vlivu poškození ledvin na účinnost a bezpečnost dvou dávek přípravku Bludigo™ (injekce indigotindisulfonátu sodného, USP) 0,8 % při použití jako pomůcka při určování průchodnosti močovodů
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
An estimated glomerular filtration rate (eGFR) at baseline will be determined using the Modification of Diet in Renal Disease (MDRD) and standardized by using individual's body surface area as described in the FDA's Renal Impairment guidance. Qualified subjects/patients will be stratified into 4 cohorts based on their eGFR at baseline: patients with normal renal function (eGFR ≥ 90 mL/min), patients with mild (eGFR 60-89 mL/min), moderate (eGFR 30-59 mL/min) and severe (eGFR 15-29 mL/min) renal impairment.
Up to ten study centers in the United States will enroll up to approximately 12 subjects per cohort (48 subjects in total) scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive covering the full renal function range from normal, mild, moderate, and severe renal impairment. For each subject/patient the study will consist of a screening period (Day -30 to Day -2), a baseline evaluation (Day -1 to Day 1) and a single treatment period (Day 1) with an onsite observation period of 24 hours post-dose. After signing the informed consent, review of inclusion and exclusion criteria will be performed, the collection of concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit.
On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by cohort and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). All randomized subjects will serve as his/her own control (i.e., intra-patient controlled) for efficacy by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose. The surgeon will be blinded to the Bludigo™ dose a subject receives. Time of injection of saline and Bludigo™ will be captured.
All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28.
Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Michelle Boytim, P.hD.
- Telefonní číslo: 610-850-7115
- E-mail: michelle.boytim@provepharm.com
Studijní místa
-
-
New York
-
Albany, New York, Spojené státy, 12008
- Nábor
- Albany Medical Center
-
Kontakt:
- Mark D White, MD
- Telefonní číslo: 518-262-8579
- E-mail: whitem@amc.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Saline
48 subjects treated with 5 ml of saline then crossover to treatment arm |
Placebo |
|
Experimentální: High Dose
24 subjects randomly treated with 5 mL of 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.
Ostatní jména:
Placebo |
|
Experimentální: Low Dose
24 subjects randomly treated with 2.5 mL of 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.
Ostatní jména:
Placebo |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Paired sample difference (Bludigo - Saline) in urine jet conspicuity score.
Časové okno: 10 to 15 minutes post study drug administration
|
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:
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
Časové okno: 10 to 15 minutes post study drug administration
|
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:
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of adverse events and serious adverse events.
Časové okno: 30 days post study drug administration
|
Percentage of patients in each treatment group who experience an adverse event post treatment |
30 days post study drug administration
|
|
Changes in clinical safety laboratory values
Časové okno: 30 days post study drug administration
|
Proportion of subjects with clinically important changes in clinical safety laboratory tests after treatment |
30 days post study drug administration
|
|
Changes in vital signs post treatment
Časové okno: 30 days post study drug administration
|
Proportion of subjects with clinically important changes in vital signs after treatment |
30 days post study drug administration
|
|
Changes in ECG post treatment
Časové okno: 30 days post study drug administration
|
Proportion of subjects with clinically important changes in ECGs after treatment |
30 days post study drug administration
|
|
Changes in blood pressure by dose group and Renal Impairment Cohort
Časové okno: 30 days post study drug administration
|
Comparison of post treatment changes in blood pressure by dose group and renal impairment cohort (normal renal function, mild, moderate, and severe impairment) |
30 days post study drug administration
|
|
Changes in heart rate by dose group and Renal Impairment Cohort
Časové okno: 30 days post study drug administration
|
Comparison of post treatment changes in heart rate by dose group and renal impairment cohort (normal renal function, mild, moderate, and severe impairment) |
30 days post study drug administration
|
|
Changes in pulse oximetry by dose group and Renal Impairment Cohort
Časové okno: 30 days post study drug administration
|
Comparison of post treatment changes in pulse oximetry by dose group and renal impairment cohort (normal renal function, mild, moderate, and severe impairment) |
30 days post study drug administration
|
|
Time to visualization
Časové okno: 10 to 15 minutes post study drug administration
|
To describe the time to visualization (TTV) of blue color in the ureteral jets flow following Bludigo™ treatment |
10 to 15 minutes post study drug administration
|
|
Physician Satisfaction
Časové okno: 10 to 15 minutes post study drug administration
|
To determine physicians' overall satisfaction with the Bludigo™ treatment by assessing the proportion of surgeons who agree using the 5-point Physician Satisfaction Agreement Scale (PSAS) with the statement: "Compared to the saline treatment, my ability to assess ureter patency was improved after the addition of Bludigo™."
|
10 to 15 minutes post study drug administration
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Difference between the Bludigo™ high dose vs Bludigo™ low dose in urine jet conspicuity score
Časové okno: 10 to 15 minutes post study drug administration
|
An exploratory comparison will be performed to assess the difference between the Bludigo™ high dose vs Bludigo™ low dose in urine jet conspicuity score. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows:
|
10 to 15 minutes post study drug administration
|
|
Impact of renal impairment on renal elimination of Bludigo™
Časové okno: 12 hours post study drug administration
|
An exploratory comparison will be performed to assess the 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
Časové okno: 12 hours post study drug administration
|
An exploratory assessments of the amount of Bludigo excreted in urine in patients with and without renal impairment. |
12 hours post study drug administration
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Michelle Boytim, Ph.D., Provepharm SAS
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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