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

Phase 1

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Drug: daptomycin

• Registration Number: NCT00490737
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Study Timeline

• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-25
• Study Start: 2007-08-12
• Primary Completion: 2008-05-12
• Study Completion: 2008-05-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-07
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemodialysis (HD) Participants	daptomycin	Participants will receive daptomycin 6 mg/kg by intravenous infusion (i.v.) at 48-hours intervals (with dialysis) for a total of 3 doses.
Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants	daptomycin	Participants will receive daptomycin 6 mg/kg, i.v., at 48-hours intervals for a total of 3 doses.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	Study Day 1, 3, 5 and 7 or 8

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	Study Days 1 through 16 or 17