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

Status Terminated

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

Clinical Trial 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

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

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

• NCT number: NCT00150319
• Study type: Interventional
• Source: Pfizer
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: June 2005
• Completion date: October 2005