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

ID: NCT00490737
Status: Completed
Phase: Phase 1
Start Date: August 12, 2007
First Submitted: June 22, 2007
Last Updated: January 07, 2018
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: N/A
Conditions: End-Stage Renal Disease
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Study Description

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.
Condition or disease Intervention/treatment Phase

End-Stage Renal Disease

Drug: daptomycin
Other Names
Cubicin
Phase 1

Tracking Information

First Submitted DateJune 22, 2007
Last Update Posted DateJanuary 07, 2018
Actual Start DateAugust 12, 2007
Actual Completion DateMay 12, 2008
Actual Primary Completion DateMay 12, 2008
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Pharmacokinetics [Time Frame: Study Day 1, 3, 5 and 7 or 8]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Safety and Tolerability [Time Frame: Study Days 1 through 16 or 17]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)
Official TitleAn 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
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 TypeInterventional
Study PhasePhase 1
Estimated Enrollment
12
Allocation
Non-Randomized
Interventional Model
Parallel Assignment
Masking
None
Primary Purpose
Basic Science
Conditions
End-Stage Renal Disease
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: daptomycin

6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses

Other Names
Cubicin
Study Groups/Cohorts
Hemodialysis (HD) Participants
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
Participants will receive daptomycin 6 mg/kg, i.v., at 48-hours intervals for a total of 3 doses.

Study Arms
Experimental Continuous Ambulatory Peritoneal Dialysis (CAPD) Participants
Participants will receive daptomycin 6 mg/kg, i.v., at 48-hours intervals for a total of 3 doses.
Drug : daptomycin
6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses

Experimental Hemodialysis (HD) Participants
Participants will receive daptomycin 6 mg/kg by intravenous infusion (i.v.) at 48-hours intervals (with dialysis) for a total of 3 doses.
Drug : daptomycin
6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses

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

Recruitment Information

Recruitment Status:Completed
Enrollment12
Completion DateMay 12, 2008
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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00490737
Other Study ID Numbers
3009-021
DAP-REN-07-01
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Medical Director
Merck Sharp & Dohme Corp.