Status:
COMPLETED
Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
End-stage Renal Disease
Renal Failure Chronic Requiring Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 sessi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00882557
Start Date
April 29 2009
End Date
July 17 2009
Last Update
February 6 2018
Active Locations (2)
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1
West Coast Clinical Trials
Cypress, California, United States, 90630
2
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404