Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2018 |
Start Date: | April 29, 2009 |
End Date: | July 17, 2009 |
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
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.
the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after
a dialysis session.
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.
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