Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

Condition(s) targeted: End Stage Renal Disease

Intervention: Ertapenem (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Oakwood Hospital and Medical Center

Official(s) and/or principal investigator(s):
Raymond Cha, Pharm.D., Principal Investigator, Affiliation: Oakwood Hospital and Medical Center
Sin-Ling T Jennings, Pharm.D., Study Chair, Affiliation: Oakwood Hospital and Medical Center

Overall contact:
Raymond Cha, Pharm.D., Phone: 313-982-5496, Email: raymond.cha@oakwood.org

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

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

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Mean maximum concentration (Cmax) of ertapenem in hemodialysis patients

Mean minimum concentration (Cmin) of ertapenem in hemodialysis patients

Mean area under the curve (AUC) of ertapenem in hemodialysis patients

Mean terminal elimination rate constant (ke) of ertapenem in hemodialysis patients

Mean terminal half life (t1/2) of ertpenem in hemodialysis patients

Mean time to Cmax of ertapenem in hemodialysis patients

Secondary outcome:

Number of participants with diarrhea

Number of participants with nausea and vomiting

Number of participants with headache

Number of participants with injection site reaction

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.

Minimum age: 18 Years. Maximum age: 88 Years. Gender(s): Both.

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

- 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

Raymond Cha, Pharm.D., Phone: 313-982-5496, Email: raymond.cha@oakwood.org

Oakwood Hospital and Medical Center, Dearborn, Michigan 48124, United States; Not yet recruiting
Raymond Cha, Pharm.D., Phone: 313-982-5496, Email: raymond.cha@oakwood.org
Sin-Ling T Jennings, Pharm.D., Phone: 313-593-8759, Email: sin-ling.jennings@oakwood.org
Raymond Cha, Pharm.D., Principal Investigator
Sin-Ling T Jennings, Pharm.D., Sub-Investigator
Lama Hsaiky, Pharm.D., Sub-Investigator
Francine Salinitri, Pharm.D., Sub-Investigator
Rabih Bazzi, MD, Sub-Investigator
Alison Britt, Sub-Investigator

Starting date: June 2014
Last updated: June 7, 2014