Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)

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

Status and phase

Completed

Phase 1

Conditions

End-Stage Renal Disease

Treatments

Drug: daptomycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00490737

DAP-REN-07-01 (Other Identifier)

3009-021

Details and patient eligibility

About

This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.

Full description

This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of intravenous ( i.v.) daptomycin. Non-infected subjects with end stage renal disease undergoing hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) will be enrolled in this in-patient study.

Enrollment

12 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;
Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
Male or female >18 years of age;
If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for >28 days after study completion;
If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration;
Functioning dialysis access (e.g. graft or fistula) for subjects undergoing HD and functioning dialysis access (e.g. peritoneal catheter) for subjects undergoing CAPD;
ESRD on stable HD regimen of thrice weekly sessions with high-flux membranes or stable CAPD regimen.

Exclusion criteria

If female, pregnant or lactating;
Received an investigational drug (including experimental biologic agents) within 30 days of study entry;
Evidence of active ongoing infection;
Unable to discontinue use of HMG-CoA reductase inhibitor therapy for duration of study;
Has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug;
Known to be allergic or intolerant to daptomycin;
Body Mass Index (BMI) < 18.5 or > 40 kg/m2 [BMI = weight (kg)/height (m2)];
WBC >12, 000 cells/mm3 or <2500 cells/ mm3;
Baseline creatinine phosphokinase (CPK) values >3X ULN (upper limit of normal);
Alanine aminotransferase (ALT) >5X ULN;
Aspartate aminotransferase (AST) >5X ULN;
Known HIV-infected subjects with CD4 count ≤200 cells/mm3;
Hemoglobin < 9 gm/dL;
Active illicit drug and/or alcohol abuse;
Myocardial infarction within last 6 months;
Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days;
Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy);
Subjects with a history of neurological disease (e.g., Guillain Barré, multiple sclerosis), except stroke >6 months prior to study entry;
Intramuscular injection within 7 days of study drug administration;
Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days);
Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
Neutropenic subjects with absolute neutrophil count ≤500 cells/mm3 History of rhabdomyolysis.