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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490737
First Posted: June 25, 2007
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
  Purpose
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.

Condition Intervention Phase
End-Stage Renal Disease Drug: daptomycin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals LLC:

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

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

Enrollment: 12
Actual Study Start Date: June 1, 2007
Study Completion Date: May 1, 2008
Primary Completion Date: May 1, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Cubicin
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
Other Name: Cubicin

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490737


Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00490737     History of Changes
Other Study ID Numbers: 3009-021
DAP-REN-07-01 ( Other Identifier: Cubist Study Number )
First Submitted: June 22, 2007
First Posted: June 25, 2007
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cubist Pharmaceuticals LLC:
ESRD
dialysis
hemodialysis
continuous ambulatory peritoneal dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents