Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

Pharmacokinetics and Investigation of Optimal Dose of Invanz (Ertapenem) in Hemodialysis Patients

The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Ertapenem

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Oakwood Hospital - Dearborn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ertapenem; 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

Drug: Ertapenem; Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn; Other Names: Invanz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
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	Up to seven days after the administration of ertapenem
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	Up to seven days after the administration of ertapenem
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	Up to seven days after the administration of ertapenem
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	Up to seven days after the administration of ertapenem

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Adverse Events	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	Up to seven days after the administration of ertapenem

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Collaborators: Wayne State University
• Investigators: Principal Investigator: Lama Hsaiky, Pharm.D., Oakwood Hospital - Dearborn; Study Chair: Lama Hsaiky, Pharm.D., Oakwood Hospital - Dearborn

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: June 7, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: pharmacokinetic; hemodialysis; pharmacodynamics; ertapenem; requires hemodialysis three times a week
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anti-Infective Agents; Anti-Bacterial Agents; Ertapenem
• Other Study ID Numbers: OH-D-Ertapenem-HD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No