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An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00150319
Recruitment Status : Terminated (See Detailed Description)
First Posted : September 8, 2005
Last Update Posted : September 29, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency

Condition or disease Intervention/treatment Phase
Kidney Failure Drug: Vfend®; I.V. Phase 1 Phase 2

Detailed Description:
The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Iv Containing Sbecd As An Excipient Following Multiple Dosing With Vfend®; I.V. In Subjects With Moderately Impaired Renal Function
Study Start Date : June 2005
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate renal insufficiency

Exclusion Criteria:

  • Active infection
Contacts and Locations

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): NCT00150319


Locations
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70118
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70119
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78727
Pfizer Investigational Site
Austin, Texas, United States, 78758
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00150319     History of Changes
Other Study ID Numbers: A1501070
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
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