The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
intradialytic: 9 mg/kg during the last 30 minutes of dialysis
6 mg/kg administered after a hemodialysis session
West Coast Clinical Trials
Cypress, California, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Evaluation of Area Under the Curve From Time 0 to Infinity
Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses
Time frame: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)
Treatment-emergent Adverse Events
Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.
Time frame: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).
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