NCT00150319

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

September 6, 2005

Last Update Submit

September 25, 2008

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (1)

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

Interventions

Vfend®; I.V.DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate renal insufficiency

You may not qualify if:

  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

New Orleans, Louisiana, 70118, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70119, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37920, United States

Location

Pfizer Investigational Site

Austin, Texas, 78727, United States

Location

Pfizer Investigational Site

Austin, Texas, 78758, United States

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

September 29, 2008

Record last verified: 2008-09

Locations

US(6)