Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

Completed · Phase 1

Conditions studied: End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis

In brief

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.

Key facts

Study ID

NCT00882557

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

16

Starts

2009-04-29

Expected to finish

2009-07-17

Last updated by the study team

2018-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• West Coast Clinical Trials — Cypress, California, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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