Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159859
• Other study ID #: OH-D-Ertapenem-HD
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2018
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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 ß 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Ertapenem
Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn

Locations

Country	Name	City	State
United States	Oakwood Hospital - Dearborn	Dearborn	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2018 Jul 9. doi: 10.1093/ndt/gfy166. [Epub ahead of p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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