Safety Study to Evaluate Daptomycin in Non-Infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis|
- Pharmacokinetics [ Time Frame: Study Day 1, 3, 5 and 7 or 8 ] [ Designated as safety issue: No ]
- Safety and Tolerability [ Time Frame: Study Days 1 through 16 or 17 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
6mg/kg i.v.; every 48 hours for a total of 3 doses
Other Name: Cubicin
Patients with moderate or severe renal insufficiency (CLcr <50 mL/min) are not only at increased risk of infection, but also have worse outcomes from a given infection. In fact, infection accounts for the second leading cause of mortality among patients with end-stage renal disease (ESRD). Many of these infections are due to sepsis, primarily rising from the vascular access and peritoneal catheter sites.
This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of i.v. daptomycin. Non-infected subjects with end stage renal disease undergoing HD or CAPD will be enrolled in this in-patient study.