Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

NCT02159859 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OH-D-Ertapenem-HD
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End Stage Renal Disease

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Number of Participants With Diarrhea

  Up to seven days after the administration of ertapenem

• Number of Participants With Nausea and Vomiting

  Up to seven days after the administration of ertapenem

• Number of Participants With Headache

  Up to seven days after the administration of ertapenem

• Number of Participants With Injection Site Reaction

  Up to seven days after the administration of ertapenem

Other Outcomes (1)

• Number of Participants With Any Adverse Events

  Up to seven days after the administration of ertapenem

Study Arms (1)

Ertapenem

EXPERIMENTAL

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

Interventions

Ertapenem DRUG

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

Also known as: Invanz

Ertapenem

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead
• Wayne State University: collaborator

Study Sites (1)

Oakwood Hospital - Dearborn

Dearborn, Michigan, 48124, United States

Location

Related 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. 2019 Oct 1;34(10):1766-1772. doi: 10.1093/ndt/gfy166.

  PMID: 29992286 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

some participants had missing lab values at the pre-determined times

Results Point of Contact

• Title: Lama Hsaiky, Pharm.D. (Primary investigator)
• Organization: Beaumont Health

lama.hsaiky@beaumont.org

313-593-7264

Study Officials

• Lama Hsaiky, Pharm.D.

  Oakwood Hospital - Dearborn

  PRINCIPAL INVESTIGATOR

• Lama Hsaiky, Pharm.D.

  Oakwood Hospital - Dearborn

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 10, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 17, 2018
• Results First Posted: June 15, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)