Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
|ClinicalTrials.gov Identifier: NCT00882557|
Recruitment Status : Completed
First Posted : April 16, 2009
Results First Posted : October 25, 2011
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis||Drug: daptomycin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Crossover-design Study to Evaluate the Pharmacokinetics and Safety of Daptomycin Administered at 9 mg/kg During and 6 mg/kg After Hemodialysis|
|Actual Study Start Date :||April 29, 2009|
|Actual Primary Completion Date :||July 17, 2009|
|Actual Study Completion Date :||July 17, 2009|
9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.
intradialytic: 9 mg/kg during the last 30 minutes of dialysis
Other Name: Cubicin
Post dialysis dosing
6 mg/kg administered after a hemodialysis session
Other Name: Cubicin
- Evaluation of Area Under the Curve From Time 0 to Infinity [ 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) ]Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses
- Treatment-emergent Adverse Events [ 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). ]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.
- Maximum Plasma Concentration [ 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) ]Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.
- Time to Maximum Concentration [ Time Frame: Up to 68 hours post dose ]Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.
- Half-life [ Time Frame: Up to 68 hours post dose ]Apparent terminal half-life.
- Clearance of Daptomycin [ Time Frame: Up to 68 hours post dose ]Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.
- Volume of Distribution [ Time Frame: Up to 68 hours post dose ]Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882557
|United States, California|
|West Coast Clinical Trials|
|Cypress, California, United States, 90630|
|United States, Minnesota|
|DaVita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|
|Study Director:||Alistair Wheeler, MD, MFPM||Cubist Pharmaceuticals LLC|