Safety Study to Evaluate Daptomycin in Non-Infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00490737
First received: June 22, 2007
Last updated: June 12, 2008
Last verified: June 2008
  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: 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:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Study Day 1, 3, 5 and 7 or 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Study Days 1 through 16 or 17 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: daptomycin
6mg/kg i.v.; every 48 hours for a total of 3 doses
Other Name: Cubicin

Detailed Description:

Patients with moderate or severe renal insufficiency (CLcr <50 mL/min) are not only at increased risk of infection, but also have worse outcomes from a given infection. In fact, infection accounts for the second leading cause of mortality among patients with end-stage renal disease (ESRD). Many of these infections are due to sepsis, primarily rising from the vascular access and peritoneal catheter sites.

This is an open label, non-randomized, non-comparative Phase 1 study designed to evaluate the PK profile, safety and tolerability of i.v. daptomycin. Non-infected subjects with end stage renal disease undergoing HD or CAPD will be enrolled in this in-patient study.

  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;
  • 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
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: NCT00490737

Locations
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Nebraska
Omaha, Nebraska, United States
Sponsors and Collaborators
Cubist Pharmaceuticals
  More Information

No publications provided by Cubist Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ed Campanaro, Cubist Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00490737     History of Changes
Other Study ID Numbers: DAP-REN-07-01
Study First Received: June 22, 2007
Last Updated: June 12, 2008
Health Authority: United States: Food and Drug Administration

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

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