Fondaparinux in Critically Ill Patients With Renal Failure

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Steven Dov Tennenberg, MD, Wayne State University
ClinicalTrials.gov Identifier:
NCT01467583
First received: November 3, 2011
Last updated: June 18, 2015
Last verified: June 2015
Results First Received: March 17, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Intervention: Drug: Fondaparinux

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Renal Failure, on Intermittent Hemodialysis (IHD)

These are patients with renal failure, on intermittent dialysis

Fondaparinux: 2.5 mg every 48 hours

Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours These are renal failure patients, either acute or chronic on Fondaparinux: 2.5 mg every 48 hours
Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr

These are patients with acute kidney injury not yet on dialysis

Fondaparinux: 2.5 mg every 48 hours


Participant Flow:   Overall Study
    Renal Failure, on Intermittent Hemodialysis (IHD)     Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours     Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr  
STARTED     16     4     12  
COMPLETED     14 [1]   3 [2]   10  
NOT COMPLETED     2     1     2  
Death                 1                 1                 0  
Withdrawal by Subject                 1                 0                 0  
Protocol Violation                 0                 0                 2  
[1] Both patients completed > 1 dose and so their data was included in the results.
[2] Death unrelated to study drug on day #3. Data to that point is included in the results



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Renal Failure, on Intermittent Hemodialysis (IHD)

These are patients with renal failure, on intermittent dialysis

Fondaparinux: 2.5 mg every 48 hours

Renal Failure, on CRRT Fondaparinux: 2.5 mg every 48 hours
Renal Failure, Not on Dialysis

These are patients with acute kidney injury not yet on dialysis

Fondaparinux: 2.5 mg every 48 hours

Total Total of all reporting groups

Baseline Measures
    Renal Failure, on Intermittent Hemodialysis (IHD)     Renal Failure, on CRRT     Renal Failure, Not on Dialysis     Total  
Number of Participants  
[units: participants]
  16     4     12     32  
Age  
[units: years]
Mean (Standard Deviation)
  61  (12)     63  (10)     62  (12)     62  (12)  
Gender  
[units: participants]
       
Female     5     1     6     12  
Male     11     3     6     20  
Region of Enrollment  
[units: participants]
       
United States     16     4     12     32  



  Outcome Measures
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1.  Primary:   To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.   [ Time Frame: 2 years ]

2.  Secondary:   To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Krista Wahby, Critical Care Pharmacist in the Medical ICU
Organization: Harper University Hospital
phone: 313-745-2711
e-mail: kwahby@dmc.org



Responsible Party: Steven Dov Tennenberg, MD, Wayne State University
ClinicalTrials.gov Identifier: NCT01467583     History of Changes
Other Study ID Numbers: 112050
Study First Received: November 3, 2011
Results First Received: March 17, 2015
Last Updated: June 18, 2015
Health Authority: United States: Food and Drug Administration