Clinical trial NCT00490737: Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)
Official title: An Evaluation of the Pharmacokinetic Profile and Safety and Tolerability of Multiple Doses of 6mg/kg Intravenous Daptomycin in Non-Infected Adult Subjects With End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End-Stage Renal Disease
Keywords: ESRD
dialysis
hemodialysis
continuous ambulatory peritoneal dialysis
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: Study Day 1, 3, 5 and 7 or 8
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Study Days 1 through 16 or 17
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Benziger DP, Pertel PE, Donovan J, Yankelev S, Schwab RJ, Swan SK, Cannon C. Pharmacokinetics and safety of multiple doses of daptomycin 6 mg/kg in noninfected adults undergoing hemodialysis or continuous ambulatory peritoneal dialysis. Clin Nephrol. 2011 Jan;75(1):63-9.