NCT00939952

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 26, 2013

Completed
Last Updated

February 26, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

July 14, 2009

Results QC Date

July 25, 2012

Last Update Submit

January 22, 2013

Conditions

Continuous Ambulatory Peritoneal DialysisEnd Stage Renal Disease

Keywords

ertapenemCAPDdialysis

Outcome Measures

Primary Outcomes (7)

  • Volume of Distribution, Central Compartment (Vc)

    Population PK

    12h

  • Clearance (CL)

    population PK clearance

    12h

  • k12

    1st order intercompartmental rate constant between central and peripheral compartments

    12h

  • k21

    1st order intercompartmental rate constant from peripheral to central compartment

    12h

  • k13

    1st order intercompartmental rate constant from central to peritoneal cavity

    12h

  • k31

    1st order intercompartmental rate constant peritoneal cavity to central

    12h

  • Residual Drug in Peritoneal Cavity After 1st Exchange

    6h

Study Arms (1)

ertapenem 500 mg IV x1

ACTIVE COMPARATOR

All patients will receive ertapenem 500 mg IV once.

Drug: ertapenem

Interventions

ertapenemDRUG

500 mg IV once

Also known as: Invanz
ertapenem 500 mg IV x1

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hortense and Louis Rubin Dialysis Center

Clifton Park, New York, 12065, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Katie Cardone
Organization
Albany College of Pharmacy and Health Sciences
katie.cardone@acphs.edu
518-694-7875

Study Officials

  • Katie E Cardone, PharmD

    Albany College of Pharmacy and Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 26, 2013

Results First Posted

February 26, 2013

Record last verified: 2013-01

Locations

US(1)