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Completed

NCT Number: NCT02159859

Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

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

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oakwood Hospital - Dearborn

Dearborn, Michigan, 48124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertapenem

Drug

Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn

Other names: Invanz

Primary outcomes

  1. Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients

    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

    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

  2. Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients

    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

    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

  3. Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients

    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

    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

  4. Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients

    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

    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

  5. Mean Time to Cmax of Ertapenem in Hemodialysis Patients

    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

    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 outcomes

  1. Number of Participants With Diarrhea

    Time frame: Up to seven days after the administration of ertapenem

    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

  2. Number of Participants With Nausea and Vomiting

    Time frame: Up to seven days after the administration of ertapenem

    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

  3. Number of Participants With Headache

    Time frame: Up to seven days after the administration of ertapenem

    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

  4. Number of Participants With Injection Site Reaction

    Time frame: Up to seven days after the administration of ertapenem

    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

Other outcomes

  1. Number of Participants With Any Adverse Events

    Time frame: Up to seven days after the administration of ertapenem

    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

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • Wayne State University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2014
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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