End-Stage Renal Disease
Conditions
Keywords
ESRD, dialysis, hemodialysis, continuous ambulatory peritoneal dialysis
Brief summary
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
Detailed description
This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin. Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.
Interventions
DRUGdaptomycin
6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses
Sponsors
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent prior to any study-related procedure not part of normal medical care; * Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment; * Male or female \>18 years of age; * If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for \>28 days after study completion; * If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration; * Functioning dialysis access (e.g. graft or fistula) for subjects undergoing HD and functioning dialysis access (e.g. peritoneal catheter) for subjects undergoing CAPD; * ESRD on stable HD regimen of thrice weekly sessions with high-flux membranes or stable CAPD regimen.
Exclusion criteria
* If female, pregnant or lactating; * Received an investigational drug (including experimental biologic agents) within 30 days of study entry; * Evidence of active ongoing infection; * Unable to discontinue use of HMG-CoA reductase inhibitor therapy for duration of study; * Has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug; * Known to be allergic or intolerant to daptomycin; * Body Mass Index (BMI) \< 18.5 or \> 40 kg/m2 \[BMI = weight (kg)/height (m2)\]; * WBC \>12, 000 cells/mm3 or \<2500 cells/ mm3; * Baseline creatinine phosphokinase (CPK) values \>3X ULN (upper limit of normal); * Alanine aminotransferase (ALT) \>5X ULN; * Aspartate aminotransferase (AST) \>5X ULN; * Known HIV-infected subjects with CD4 count ≤200 cells/mm3; * Hemoglobin \< 9 gm/dL; * Active illicit drug and/or alcohol abuse; * Myocardial infarction within last 6 months; * Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days; * Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy); * Subjects with a history of neurological disease (e.g., Guillain Barré, multiple sclerosis), except stroke \>6 months prior to study entry; * Intramuscular injection within 7 days of study drug administration; * Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days); * Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations; * Neutropenic subjects with absolute neutrophil count ≤500 cells/mm3 History of rhabdomyolysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Study Day 1, 3, 5 and 7 or 8 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | Study Days 1 through 16 or 17 |
Outcome results
None listed