Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
NCT ID: NCT01120314
Last Updated: 2014-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2010-04-30
2011-07-31
Brief Summary
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* To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban.
Secondary Objective:
* To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
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Detailed Description
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* 2 to 28 days of screening,
* 1 day of treatment,
* 8 to 11 days of follow-up after start of infusion.
There are 5 days in the unit starting the day before the start of infusion.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Severe renal impairment population
OTAMIXABAN (XRP0673)
Form: solution for injection
Route: intravenous
Moderate renal impairment population
OTAMIXABAN (XRP0673)
Form: solution for injection
Route: intravenous
Mild renal impairment population
OTAMIXABAN (XRP0673)
Form: solution for injection
Route: intravenous
Healthy population
Healthy matched subjects
OTAMIXABAN (XRP0673)
Form: solution for injection
Route: intravenous
Interventions
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OTAMIXABAN (XRP0673)
Form: solution for injection
Route: intravenous
Eligibility Criteria
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Inclusion Criteria
* Mild, moderate or severe renal impairment defined as Creatinine Clearance (CrCl) from 50 to 80, 30 to 50 and \< 30 mL/min respectively, based on the Cockcroft-Gault formula,
* Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 95.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive.
* Stable chronic renal impairment as defined by Cockcroft-Gault formula,
* Vital signs, cardiac function and laboratory parameters within the acceptable range.
* Or matched subject (by age, gender and body weight) with normal renal function (defined as CrCl \>80 mL/min) and certified as healthy by physical examination, medical history and laboratory findings.
* If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
Exclusion Criteria
* Active hepatitis, hepatic insufficiency.
* Acute renal failure, nephrotic syndrome.
* History of or current hematuria of urologic origin.
* Subject requiring dialysis during the study.
* History or presence of drug or alcohol abuse within two years before inclusion.
* Smoking more than 15 cigarettes or equivalent per day.
* Any significant change in chronic treatment medication within 14-days before inclusion.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
79 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840003
Miami Gardens, Florida, United States
Investigational Site Number 840005
Orlando, Florida, United States
Investigational Site Number 840004
Saint Paul, Minnesota, United States
Investigational Site Number 840002
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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U1111-1116-5821
Identifier Type: OTHER
Identifier Source: secondary_id
POP6537
Identifier Type: -
Identifier Source: org_study_id
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