Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01120314
First received: May 6, 2010
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Renal Impairment
Drug: OTAMIXABAN (XRP0673)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 µg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC)) [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR)) [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Severe renal impairment population Drug: OTAMIXABAN (XRP0673)

Form: solution for injection

Route: intravenous

Experimental: Moderate renal impairment population Drug: OTAMIXABAN (XRP0673)

Form: solution for injection

Route: intravenous

Experimental: Mild renal impairment population Drug: OTAMIXABAN (XRP0673)

Form: solution for injection

Route: intravenous

Experimental: Healthy population
Healthy matched subjects
Drug: OTAMIXABAN (XRP0673)

Form: solution for injection

Route: intravenous


Detailed Description:

The study period for one subject is broken down as follows:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120314

Locations
United States, Florida
Investigational Site Number 840003
Miami Gardens, Florida, United States, 33169
Investigational Site Number 840005
Orlando, Florida, United States, 32806
United States, Minnesota
Investigational Site Number 840004
St. Paul, Minnesota, United States, 55144
United States, Tennessee
Investigational Site Number 840002
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01120314     History of Changes
Other Study ID Numbers: POP6537, U1111-1116-5821
Study First Received: May 6, 2010
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014