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

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150319
First received: September 6, 2005
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Kidney Failure
Drug: Vfend®; I.V.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Enrollment: 1
Study Start Date: June 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate renal insufficiency

Exclusion Criteria:

  • Active infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00150319     History of Changes
Other Study ID Numbers: A1501070
Study First Received: September 6, 2005
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
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 April 16, 2014