Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

• ClinicalTrials.gov Identifier: NCT02159859
• Recruitment Status: Completed
• First Posted: June 10, 2014
• Results First Posted: June 15, 2017
• Last Update Posted: October 17, 2018
• Sponsor: William Beaumont Hospitals
• Collaborator: Wayne State University
• Information provided by (Responsible Party): William Beaumont Hospitals

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease	Drug: Ertapenem	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pharmacokinetics and Investigation of Optimal Dose of Invanz (Ertapenem) in Hemodialysis Patients
• Study Start Date: December 2014
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

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 Name: Invanz

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Michigan

Oakwood Hospital - Dearborn

Dearborn, Michigan, United States, 48124

Sponsors and Collaborators

William Beaumont Hospitals

Wayne State University

Investigators

• Principal Investigator: Lama Hsaiky, Pharm.D.; Oakwood Hospital - Dearborn
• Study Chair: Lama Hsaiky, Pharm.D.; Oakwood Hospital - Dearborn

More Information

Publications of Results:

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.

• Responsible Party: William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT02159859
• Other Study ID Numbers: OH-D-Ertapenem-HD
• First Posted: June 10, 2014
• Results First Posted: June 15, 2017
• Last Update Posted: October 17, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by William Beaumont Hospitals:

ertapenem; pharmacokinetic; pharmacodynamics; hemodialysis; requires hemodialysis three times a week

Additional relevant MeSH terms:

Kidney Failure, Chronic; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Ertapenem; Anti-Bacterial Agents; Anti-Infective Agents