Trial Outcomes & Findings for Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients (NCT NCT02159859)
NCT ID: NCT02159859
Last Updated: 2018-10-17
Results Overview
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
COMPLETED
PHASE2
7 participants
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
2018-10-17
Participant Flow
Participant milestones
| Measure |
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
Ertapenem: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Age, Continuous
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60 years
STANDARD_DEVIATION 11.4 • n=39 Participants
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Sex: Female, Male
Female
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2 Participants
n=39 Participants
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Sex: Female, Male
Male
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5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=39 Participants
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Race (NIH/OMB)
White
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2 Participants
n=39 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Region of Enrollment
United States
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7 Participants
n=39 Participants
|
|
weight
|
77.7 kilograms
STANDARD_DEVIATION 18.3 • n=39 Participants
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PRIMARY outcome
Timeframe: 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 sessionMean 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
|
|---|---|
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Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients
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663.1 mcg/ml
Standard Deviation 904.9
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PRIMARY outcome
Timeframe: 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 sessionMean 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients
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44.3 mcg/ml
Standard Deviation 14.5
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PRIMARY outcome
Timeframe: 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 sessionMean 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients
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6225 h*ug/mL
Standard Deviation 1259
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PRIMARY outcome
Timeframe: 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 sessionMean 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients
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19.3 hours
Standard Deviation 6.6
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PRIMARY outcome
Timeframe: 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 sessionMean 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
|
|---|---|
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Mean Time to Cmax of Ertapenem in Hemodialysis Patients
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0.5 hours
Standard Deviation 0
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SECONDARY outcome
Timeframe: Up to seven days after the administration of ertapenemEvaluation 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
|
|---|---|
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Number of Participants With Diarrhea
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1 Participants
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SECONDARY outcome
Timeframe: Up to seven days after the administration of ertapenemEvaluation 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Number of Participants With Nausea and Vomiting
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1 Participants
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SECONDARY outcome
Timeframe: Up to seven days after the administration of ertapenemEvaluation 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Number of Participants With Headache
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0 Participants
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SECONDARY outcome
Timeframe: Up to seven days after the administration of ertapenemEvaluation 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Number of Participants With Injection Site Reaction
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0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to seven days after the administration of ertapenemEvaluation 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
Outcome measures
| Measure |
Ertapenem
n=7 Participants
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
|
|---|---|
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Number of Participants With Any Adverse Events
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6 Participants
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Adverse Events
Ertapenem
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ertapenem
n=7 participants at risk
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
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|---|---|
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Endocrine disorders
hypoglycemia
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42.9%
3/7 • Number of events 3 • within 7days post enrollment
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Vascular disorders
hypertension
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28.6%
2/7 • Number of events 2 • within 7days post enrollment
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Gastrointestinal disorders
nausea
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14.3%
1/7 • Number of events 1 • within 7days post enrollment
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Gastrointestinal disorders
diarrhea
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14.3%
1/7 • Number of events 1 • within 7days post enrollment
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Respiratory, thoracic and mediastinal disorders
shortness of breath
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14.3%
1/7 • Number of events 1 • within 7days post enrollment
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Musculoskeletal and connective tissue disorders
Muscle jerking
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14.3%
1/7 • Number of events 1 • within 7days post enrollment
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Renal and urinary disorders
Rusty urine
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14.3%
1/7 • Number of events 1 • within 7days post enrollment
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Additional Information
Lama Hsaiky, Pharm.D. (Primary investigator)
Beaumont Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place