A Phase 1 interventional study of Tirofiban in Renal Insufficiency, sponsored by Medicure. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-27.
Sponsored by Medicure · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate tirofiban concentration in the blood over a period of 24 hours after tirofiban administration. Subjects with varying degrees of renal insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to a slower extent compared to people without kidney problems. By comparing the tirofiban concentration profile between subjects with healthy kidney function versus with impaired kidney function, a tirofiban dosing recommendation for subjects with impaired kidney function can be made.
This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25 µg/kg administered intravenously over a 3 min period) will be administered to subjects with normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (\<30 mL/min CrCl) renal impairment with non-dialysis-dependent renal insufficiency
Tirofiban is cleared from the plasma largely by renal excretion. As a consequence, a dosage adjustment of 50% of the tirofiban label dosing regimen (0.4 μg/kg/min for a period of 30 minutes, followed by an infusion of 0.10 μg/kg/min) is recommended in patients with severe renal impairment (\<30 mL/min CrCl), including those who require hemodialysis. The dosage adjustment for the tirofiban high-dose bolus regimen (25 μg/kg bolus followed by a 0.15 μg/kg/min maintenance) for patients with varying degrees of renal insufficiency is however unknown. The purpose of this study is to determine the extent of dosage adjustment for the high-dose bolus regimen for patients with moderate (30-59 mL/min CrCl), and severe (\<30 mL/min CrCl) renal insufficiency.
This non-randomized, single-center, open-label study evaluating the pharmacokinetic (PK), pharmacodynamic (PD), and safety profile of a single high-dose IV bolus injection of tirofiban (25 µg/kg). A single dose of tirofiban will be administered to the subjects with normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (\<30 mL/min CrCl) renal impairment with non-dialysis-dependent renal insufficiency (NDDRI).
2,030 studies on the registry are indexed under Renal Insufficiency; 168 are open to participants now.
This study's enrollment of 25 is below the median of 43 across 1,534 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Medicure is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with normal renal function (CrCl \>90 mL/min)
Drug: Tirofiban
Subjects with moderate renal insufficiency (CrCl 30-59 mL/min)
Drug: Tirofiban
Subjects with severe renal insufficiency (CrCl \<30 mL/min).
Drug: Tirofiban
A single high-dose bolus (3 min IV infusion) of tirofiban (25 µg/kg)
Also known as: Aggrastat
An analysis of tirofiban plasma concentration in normal, moderate and severe renal impaired adult subjects following a single high-dose bolus (3 min IV infusion) of tirofiban (25 µg/kg).
Time frame: Subject's participation in this study will last 3 days (confinement of 48 hours).
An analysis of platelet aggregation inhibition in normal, moderate and severe renal impaired adult subjects following a single high-dose bolus (3 min IV infusion) of tirofiban (25 µg/kg).
Time frame: Baseline (prior to administration of tirofiban), 15 minutes, 1 hour, and 6 hours following the end of the tirofiban administration.
A safety analysis of high-dose bolus tirofiban
To evaluate the safety profile in normal, moderate and severe renal impaired adult subjects following a single high-dose bolus (3 min IV infusion) of tirofiban (25 µg/kg). Safety will be assessed for the duration of the subject's participation in the study which will last 3 days. If a serious adverse event is experienced the subject will be followed until the event resolves or the clinical course is stabilized. The most common adverse event associated with tirofiban is bleeding.
Time frame: Adverse events will be assessed on Day 1 (baseline), Day 2 (dosing) and Day 3 (study exit). For most subjects, no further assessment will occur after Day 3.
The record gives a start of Jan 2013, a primary completion of Feb 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tirofiban
Medicure