NCT01120314

Brief Summary

Primary Objective:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

May 6, 2010

Last Update Submit

May 9, 2014

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))

    4 days

Secondary Outcomes (1)

  • Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))

    4 days

Study Arms (4)

Severe renal impairment population

EXPERIMENTAL
Drug: OTAMIXABAN (XRP0673)

Moderate renal impairment population

EXPERIMENTAL
Drug: OTAMIXABAN (XRP0673)

Mild renal impairment population

EXPERIMENTAL
Drug: OTAMIXABAN (XRP0673)

Healthy population

EXPERIMENTAL

Healthy matched subjects

Drug: OTAMIXABAN (XRP0673)

Interventions

OTAMIXABAN (XRP0673)DRUG

Form: solution for injection Route: intravenous

Healthy populationMild renal impairment populationModerate renal impairment populationSevere renal impairment population

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject with renal impairment:
  • 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.

You may not qualify if:

  • Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
  • Active hepatitis, hepatic insufficiency.
  • Acute renal failure, nephrotic syndrome.
  • History of or current hematuria of urologic origin.
  • Subject requiring dialysis during the study.
  • Smoking more than 15 cigarettes or equivalent per day.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Investigational Site Number 840003

Miami Gardens, Florida, 33169, United States

Location

Investigational Site Number 840005

Orlando, Florida, 32806, United States

Location

Investigational Site Number 840004

Saint Paul, Minnesota, 55144, United States

Location

Investigational Site Number 840002

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

otamixaban

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 10, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

US(4)