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Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ertapenem
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease focused on measuring ertapenem, pharmacokinetic, pharmacodynamics, hemodialysis, requires hemodialysis three times a week

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015
  • Diagnosed with end stage renal disease and requires hemodialysis three times a week
  • No allergy to β lactam medications
  • Existing IV access for parenteral ertapenem infusion
  • Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post.
  • No evidence of hepatic disease
  • No history of alcoholism or drug abuse within pervious 2 years
  • Not pregnant

Exclusion Criteria:

  • History of any form of epilepsy, seizure or convulsion
  • Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states
  • Currently taking probenecid
  • Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study
  • Currently receiving any antimicrobial agents for prophylaxis or treatment

Sites / Locations

  • Oakwood Hospital - Dearborn

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ertapenem

Arm Description

Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session

Outcomes

Primary Outcome Measures

Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients
Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients
Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients
Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients
Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Time to Cmax of Ertapenem in Hemodialysis Patients
Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session

Secondary Outcome Measures

Number of Participants With Diarrhea
Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Number of Participants With Nausea and Vomiting
Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Number of Participants With Headache
Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Number of Participants With Injection Site Reaction
Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital

Full Information

First Posted
June 3, 2014
Last Updated
September 19, 2018
Sponsor
William Beaumont Hospitals
Collaborators
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT02159859
Brief Title
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Official Title
Pharmacokinetics and Investigation of Optimal Dose of Invanz (Ertapenem) in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Hospitals
Collaborators
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.
Detailed Description
After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
ertapenem, pharmacokinetic, pharmacodynamics, hemodialysis, requires hemodialysis three times a week

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ertapenem
Arm Type
Experimental
Arm Description
Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Other Intervention Name(s)
Invanz
Intervention Description
Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn
Primary Outcome Measure Information:
Title
Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients
Description
Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time Frame
once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Title
Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients
Description
Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time Frame
once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Title
Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients
Description
Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time Frame
once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Title
Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients
Description
Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time Frame
once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Title
Mean Time to Cmax of Ertapenem in Hemodialysis Patients
Description
Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Time Frame
once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Secondary Outcome Measure Information:
Title
Number of Participants With Diarrhea
Description
Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time Frame
Up to seven days after the administration of ertapenem
Title
Number of Participants With Nausea and Vomiting
Description
Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time Frame
Up to seven days after the administration of ertapenem
Title
Number of Participants With Headache
Description
Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time Frame
Up to seven days after the administration of ertapenem
Title
Number of Participants With Injection Site Reaction
Description
Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time Frame
Up to seven days after the administration of ertapenem
Other Pre-specified Outcome Measures:
Title
Number of Participants With Any Adverse Events
Description
Evaluation of any adverse events will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital
Time Frame
Up to seven days after the administration of ertapenem

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015 Diagnosed with end stage renal disease and requires hemodialysis three times a week No allergy to β lactam medications Existing IV access for parenteral ertapenem infusion Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post. No evidence of hepatic disease No history of alcoholism or drug abuse within pervious 2 years Not pregnant Exclusion Criteria: History of any form of epilepsy, seizure or convulsion Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states Currently taking probenecid Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study Currently receiving any antimicrobial agents for prophylaxis or treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama Hsaiky, Pharm.D.
Organizational Affiliation
Oakwood Hospital - Dearborn
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lama Hsaiky, Pharm.D.
Organizational Affiliation
Oakwood Hospital - Dearborn
Official's Role
Study Chair
Facility Information:
Facility Name
Oakwood Hospital - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29992286
Citation
Hsaiky LM, Salinitri FD, Wong J, Jennings ST, Desai NH, Lobkovich AM, Cha R. Pharmacokinetics and investigation of optimal dose ertapenem in intermittent hemodialysis patients. Nephrol Dial Transplant. 2019 Oct 1;34(10):1766-1772. doi: 10.1093/ndt/gfy166.
Results Reference
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Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

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