Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00882557
First received: April 15, 2009
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.


Condition Intervention Phase
End-stage Renal Disease
Renal Failure Chronic Requiring Hemodialysis
Drug: daptomycin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Crossover-design Study to Evaluate the Pharmacokinetics and Safety of Daptomycin Administered at 9 mg/kg During and 6 mg/kg After Hemodialysis

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Evaluation of Area Under the Curve From Time 0 to Infinity [ Time Frame: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion) ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses


Secondary Outcome Measures:
  • Treatment-emergent Adverse Events [ Time Frame: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15). ] [ Designated as safety issue: Yes ]
    Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.


Enrollment: 16
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.
Drug: daptomycin
intradialytic: 9 mg/kg during the last 30 minutes of dialysis
Other Name: Cubicin
Experimental: B
Post dialysis dosing
Drug: daptomycin
6 mg/kg administered after a hemodialysis session
Other Name: Cubicin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to any study-related procedure not part of normal medical care;
  • Male or female ≥ 18 years of age;
  • If female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration;
  • End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes;
  • Functioning hemodialysis access (for example, graft or fistula);
  • Considered to be in appropriate health for study entry by the Investigator (for example, no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
  • If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study drug administration.

Exclusion Criteria:

  • Received an investigational drug (including experimental biologic agents) within 30 days of study drug administration;
  • Has received any dose of daptomycin within 7 days prior to study drug administration;
  • Known to be allergic or intolerant to daptomycin;
  • Evidence of active ongoing infection;
  • Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;
  • Active illicit drug use or alcohol abuse;
  • Myocardial infarction within last 6 months;
  • Subject with a history of muscular disease (for example, polymyositis, muscular dystrophy);
  • Subject with a history of neurological disease (for example, Guillain Barré, multiple sclerosis), except stroke > 6 months prior to study entry;
  • Intramuscular injection within 7 days of study drug administration;
  • Body mass index (BMI) ≤ 18.5 or ≥ 40 kg/m2 (BMI = weight [kg]/height [m2]);
  • WBC ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3;
  • Neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3;
  • Baseline CPK values ≥ 3X ULN (upper limit of normal);
  • Alanine aminotransferase (ALT) > 5XULN;
  • Aspartate aminotransferase (AST) > 5XULN;
  • Hemoglobin ≤ 9 gm/dL;
  • Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
  • History of rhabdomyolysis.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882557

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Alistair Wheeler, MD, MFPM Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00882557     History of Changes
Other Study ID Numbers: DAP-RENID-08-06
Study First Received: April 15, 2009
Results First Received: July 19, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
End-stage renal disease
hemodialysis
chronic renal failure

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

ClinicalTrials.gov processed this record on October 23, 2014