Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
Condition: End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
Intervention: daptomycin; daptomycin
Intervention description: intradialytic: 9 mg/kg during the last 30 minutes of dialysis; 6 mg/kg administered after a hemodialysis session
Intervention MeSH terms: Daptomycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: End-stage renal disease; hemodialysis; chronic renal failure

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to any study-related procedure not part of normal
             medical care;

          -  Male or female ≥ 18 years of age;

          -  If female of childbearing potential; willing to practice reliable birth control
             measures during study treatment and for at least 28 days after study completion, not
             lactating or pregnant, and has a documented negative pregnancy test result within 24
             hours prior to study medication administration;

          -  End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three
             times weekly using high-flux membranes;

          -  Functioning hemodialysis access (for example, graft or fistula);

          -  Considered to be in appropriate health for study entry by the Investigator (for
             example, no acute, debilitating medical problems) and appropriate candidate for
             completing study treatment;

          -  If taking concomitant medications, subject must be on a relatively stable dose for at
             least two weeks prior to study drug administration.

        Exclusion Criteria:

          -  Received an investigational drug (including experimental biologic agents) within 30
             days of study drug administration;

          -  Has received any dose of daptomycin within 7 days prior to study drug administration;

          -  Known to be allergic or intolerant to daptomycin;

          -  Evidence of active ongoing infection;

          -  Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;

          -  Active illicit drug use or alcohol abuse;

          -  Myocardial infarction within last 6 months;

          -  Subject with a history of muscular disease (for example, polymyositis, muscular
             dystrophy);

          -  Subject with a history of neurological disease (for example, Guillain Barré, multiple
             sclerosis), except stroke > 6 months prior to study entry;

          -  Intramuscular injection within 7 days of study drug administration;

          -  Body mass index (BMI) ≤ 18.5 or ≥ 40 kg/m2 (BMI = weight [kg]/height [m2]);

          -  WBC ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3;

          -  Neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3;

          -  Baseline CPK values ≥ 3X ULN (upper limit of normal);

          -  Alanine aminotransferase (ALT) > 5XULN;

          -  Aspartate aminotransferase (AST) > 5XULN;

          -  Hemoglobin ≤ 9 gm/dL;

          -  Is considered unlikely to comply with study procedures or to return for scheduled
             post-treatment evaluations;

          -  History of rhabdomyolysis.