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
  Purpose

The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).


Condition Intervention Phase
Continuous Ambulatory Peritoneal Dialysis
End Stage Renal Disease
Drug: ertapenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis

Resource links provided by NLM:


Further study details as provided by Albany College of Pharmacy and Health Sciences:

Primary Outcome Measures:
  • Volume of Distribution, Central Compartment (Vc) [ Time Frame: 12h ] [ Designated as safety issue: No ]
    Population PK

  • Clearance (CL) [ Time Frame: 12h ] [ Designated as safety issue: No ]
    population PK clearance

  • k12 [ Time Frame: 12h ] [ Designated as safety issue: No ]
    1st order intercompartmental rate constant between central and peripheral compartments

  • k21 [ Time Frame: 12h ] [ Designated as safety issue: No ]
    1st order intercompartmental rate constant from peripheral to central compartment

  • k13 [ Time Frame: 12h ] [ Designated as safety issue: No ]
    1st order intercompartmental rate constant from central to peritoneal cavity

  • k31 [ Time Frame: 12h ] [ Designated as safety issue: No ]
    1st order intercompartmental rate constant peritoneal cavity to central

  • Residual Drug in Peritoneal Cavity After 1st Exchange [ Time Frame: 6h ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ertapenem 500 mg IV x1
All patients will receive ertapenem 500 mg IV once.
Drug: ertapenem
500 mg IV once
Other Name: Invanz

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

i. Inclusion criteria Adult patients (≥ 18 years), non-infected (afebrile, lack of constitutional symptoms and no leukocytosis), on a stable PD regimen (at least one month) are eligible for participation. Both patients with and without residual renal function will be studied. Non-anuric patients concurrently receiving medications with the potential to inhibit active tubular secretion will be allowed to enter the study after a 2-week washout period. These medications include H2-antagonists, trimethoprim, or probenecid. The patient and their physician at the Hortense and Louis Rubin Dialysis Center will contacted if any medication needs to be discontinued.

ii. Exclusion criteria Patients will be ineligible for the study if they have had peritonitis within the previous 4 weeks, clinical signs or symptoms of active infection, elevated white blood cell count, or treatment with any antibiotic within the previous 2 weeks. Patients with a hemoglobin (hgb) < 11 g/dL will be ineligible for study inclusion. Patients with stated or documented allergies to beta-lactams medications will not be eligible. Pregnant or breastfeeding women will not be eligible for inclusion. All women of child-bearing age will need to yield a serum hCG ≤ 5 mIU/mL within 2 weeks of the scheduled study day. Patients taking valproic acid will also be excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939952

Locations
United States, New York
Hortense and Louis Rubin Dialysis Center
Clifton Park, New York, United States, 12065
Sponsors and Collaborators
Albany College of Pharmacy and Health Sciences
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Katie E Cardone, PharmD Albany College of Pharmacy and Health Sciences
  More Information

No publications provided

Responsible Party: Katie Cardone, Assistant Professor, 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

Keywords provided by Albany College of Pharmacy and Health Sciences:
ertapenem
CAPD
dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014