Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Katie Cardone, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier:
NCT00939952
First received: July 14, 2009
Last updated: January 22, 2013
Last verified: January 2013
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Continuous Ambulatory Peritoneal Dialysis
End Stage Renal Disease
Intervention: Drug: ertapenem

  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
Patients were recruited from an outpatient dialysis center. Eligible patients were referred to study investigators by social workers or nurses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All study patients were assigned to receive study drug to explore the pharmacokinetic profile of ertapenem during CAPD. Once enrolled, patients were excluded if they developed infection.

Reporting Groups
  Description
Ertapenem 500 mg IV x1 All patients will receive ertapenem 500 mg IV once.

Participant Flow:   Overall Study
    Ertapenem 500 mg IV x1  
STARTED     7  
COMPLETED     7  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Ertapenem 500 mg IV x1 All patients will receive ertapenem 500 mg IV once.

Baseline Measures
    Ertapenem 500 mg IV x1  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  55.14  ± 17  
Gender  
[units: participants]
 
Female     2  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Volume of Distribution, Central Compartment (Vc)   [ Time Frame: 12h ]

2.  Primary:   Clearance (CL)   [ Time Frame: 12h ]

3.  Primary:   k12   [ Time Frame: 12h ]

4.  Primary:   k21   [ Time Frame: 12h ]

5.  Primary:   k13   [ Time Frame: 12h ]

6.  Primary:   k31   [ Time Frame: 12h ]

7.  Primary:   Residual Drug in Peritoneal Cavity After 1st Exchange   [ Time Frame: 6h ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Katie Cardone
Organization: Albany College of Pharmacy and Health Sciences
phone: 518-694-7875
e-mail: katie.cardone@acphs.edu


No publications provided


Responsible Party: Katie Cardone, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT00939952     History of Changes
Other Study ID Numbers: 35922, 09-006
Study First Received: July 14, 2009
Results First Received: July 25, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board