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Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis

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ClinicalTrials.gov Identifier: NCT01101386
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This study's primary objective is to determine if continuous renal replacement therapy (CRRT) can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the blood so that intravenous voriconazole can be utilized in critically ill patients with renal dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows patients to receive intravenous voriconazole without the concern of SBECD accumulation.

Condition or disease Intervention/treatment
Fungal Infection Drug: Voriconazole

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Sulfobutylether-ß-cyclodextrin Sodium (SBECD) Accumulation and Voriconazole Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Study Start Date : May 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Voriconazole
Pharmacokinetic Monitoring
 Drug: Voriconazole
Patients will be started on voriconazole 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h thereafter.
Other Name: Vfend


Outcome Measures
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Primary Outcome Measures :
  1. Determine SBECD plasma and effluent concentrations [ Time Frame: Days 1-7 ]
    Evaluate SBECD pharmacokinetics (Cmax, Cmin, AUC, half-life, CL, seiving coefficient). Predict time to SBECD accumulation in study patients


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Days 1-30 ]
  2. Determine Voriconazole and UK121-265 plasma and effluent concentrations [ Time Frame: Days 1-7 ]
    Voriconazole and UK121-265 Pharmacokinetics will be evaluated (Cmax, Cmin, AUC, elimination rate constant, half-life, CL, seiving coefficient) including determination and impact of any CYP2C19 mutations on plasma pharmacokinetic parameters


Biospecimen Retention:   Samples With DNA
Whole blood, serum, urine, effluent fluid from dialysis machine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients
Criteria

Inclusion Criteria:

  • Patients who are receiving continuous renal replacement therapy and are prescribed voriconazole therapy for the treatment or prophylaxis of a fungal infection.

Exclusion Criteria:

  • Patients expected to be on CRRT for < 5 days,
  • Patients with Child-Pugh C cirrhosis, and
  • Patients who are pregnant.
Contacts and Locations
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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): NCT01101386


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Ty H Kiser, PharmD Univesity of Colorado Anschutz Medical Campus
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01101386    
Other Study ID Numbers: 10-0136
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014
Keywords provided by University of Colorado, Denver:
Voriconazole
SBECD
pharmacokinetics
Renal Failure
Additional relevant MeSH terms:
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Mycoses
Bacterial Infections and Mycoses
Infections
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors