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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT01101386

Collaborator

(none)

Enrollment

Location

30.1

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Fungal Infection	Drug: Voriconazole

Study Design

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 1, 2010

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	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 Names: Vfend

Arm

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 Names:

Vfend

Outcome Measures

Primary Outcome Measures

Determine SBECD plasma and effluent concentrations [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

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Days 1-30]
Determine Voriconazole and UK121-265 plasma and effluent concentrations [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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