At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
daptomycin +1 moredrug
Likely dose
daptomycin 9 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Apr 16, 2009·Updated Feb 6, 2018
In Brief
A Phase 1 clinical trial evaluating daptomycin for End-stage Renal Disease and Renal Failure Chronic Requiring Hemodialysis. Completed, enrolled 16 participants across 2 sites.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartApr 2009
Primary CompletionJul 2009
TodayJul 2026
First PostedApr 16, 2009
Enrollment StartApr 29, 2009
Primary CompletionJul 17, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.2 years ago
Interventions
daptomycindrug
intradialytic: 9 mg/kg during the last 30 minutes of dialysis
daptomycindrug
6 mg/kg administered after a hemodialysis session