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

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00150319
• Other study ID #: A1501070
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 6, 2005
• Last updated: September 25, 2008
• Start date: June 2005
• Est. completion date: October 2005

Study information

• Verified date: September 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with moderate renal insufficiency

Exclusion Criteria:

• Active infection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Vfend®; I.V.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency