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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01101386
First received: April 6, 2010
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Fungal Infection
Drug: Voriconazole
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Days 1-30 ] [ Designated as safety issue: Yes ]
  • Determine Voriconazole and UK121-265 plasma and effluent concentrations [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
    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


Enrollment: 10
Study Start Date: May 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01101386

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Ty H Kiser, PharmD Univesity of Colorado Anschutz Medical Campus
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01101386     History of Changes
Other Study ID Numbers: 10-0136
Study First Received: April 6, 2010
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Voriconazole
SBECD
pharmacokinetics
Renal Failure

Additional relevant MeSH terms:
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014