Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

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

Status and phase

Completed

Phase 1

Conditions

Renal Failure Chronic Requiring Hemodialysis

End-stage Renal Disease

Treatments

Drug: daptomycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00882557

3009-027

DAP-RENID-08-06 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.