End Stage Renal DiseasePhase 2NCT02159859

Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

A Phase 2 study testing Ertapenem in people with End Stage Renal Disease, run by Corewell Health East at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 88 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: Ertapenem
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Apr 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 88 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Oakwood Hospital - Dearborn
Dearborn, Michigan, 48124

Other trials in United States

About this study

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

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

Read the 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.

Conditions: End Stage Renal Disease
Being tested: Ertapenem
Keywords: ertapenem, pharmacokinetic, pharmacodynamics, hemodialysis, requires hemodialysis three times a week
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErtapenemDrug
Also called Invanz
Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn

Study groups in NCT02159859
Study group	Role	What they receive
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 Receives: Drug: Ertapenem

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: Up to seven days after the administration of ertapenem
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
Measured: Up to seven days after the administration of ertapenem
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
Measured: Up to seven days after the administration of ertapenem
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
Measured: Up to seven days after the administration of ertapenem

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Apr 2016

First posted10 Jun 2014 (estimated)
Study startDec 2014
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02159859
Sponsor's protocol ID: OH-D-Ertapenem-HD
Status last verified: Sep 2018
First submitted: 3 Jun 2014
Last updated: 17 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29992286

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Investigation of Optimal Dose of Invanz (Ertapenem) in Hemodialysis Patients
ClinicalTrials.gov ID: NCT02159859
Acronym / sponsor ID: OH-D-Ertapenem-HD
Conditions: End Stage Renal Disease
Keywords: ertapenem, pharmacokinetic, pharmacodynamics, hemodialysis, requires hemodialysis three times a week
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Corewell Health EastUniversity, hospital or other
Collaborators: Wayne State University
Study start: Dec 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 10 Jun 2014 (estimated)
Results: Posted 15 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ertapenem	Experimental	Drug: ErtapenemSubjects 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

Who may qualify

Ages: 18 to 88 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ErtapenemAlso: InvanzSubjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn	Drug	Ertapenem

Primary outcome

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
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
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
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
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

4 secondary outcomes

Number of Participants With Diarrhea
Time frame: Up to seven days after the administration of ertapenem
Number of Participants With Nausea and Vomiting
Time frame: Up to seven days after the administration of ertapenem
Number of Participants With Headache
Time frame: Up to seven days after the administration of ertapenem
Number of Participants With Injection Site Reaction
Time frame: Up to seven days after the administration of ertapenem

Results and safety

Results posted to the registry on 15 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ertapenem	7	7

Primary outcome: 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 (Standard Deviation). Unit: mcg/ml

Measure	Ertapenem n = 7
Value	663.1 (904.9)

Primary outcome: 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 (Standard Deviation). Unit: mcg/ml

Measure	Ertapenem n = 7
Value	44.3 (14.5)

Primary outcome: Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients

Measure	Ertapenem n = 7
Value	6225 (1259)

Primary outcome: Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients

Measure	Ertapenem n = 7
Value	19.3 (6.6)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: within 7days post enrollment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertapenem	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7

Limitations and caveats (from the sponsor): some participants had missing lab values at the pre-determined times

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29992286Hsaiky 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.
Individual participant dataSharing planned: No

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lama Hsaiky, Pharm.D. principal investigator

Oakwood Hospital - Dearborn

Lama Hsaiky, Pharm.D. study chair

Oakwood Hospital - Dearborn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ertapenem in people with End Stage Renal Disease, run by Corewell Health East at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02159859, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.