Intravenous Voriconazole in Patients With Renal Compromise

NCT00332410 | Completed DMC

• 1 other identifier: IRB#0605055
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether patients with compromised renal function (CrCl \< 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran.

Conditions

Renal Transplant

Keywords

Voriconazole; renal transplant; kidney function; kidneys

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

solid organ transplant receiving voriconazole with serum creatinine level \>2

You may qualify if:

• \- Patients \> 18 years old receiving voriconazole with a serum creatinine of \> 2mg/dl (a proxy marker for Creatinine clearance \< 50ml/min). Control group in this study will have serum creatinine \< 1.5mg/dl. Solid organ transplant patient. Patient that received at least 2 doses of voriconazole.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pittsburgh: lead
• Pfizer: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.

Study Officials

• Brian Potoski, Pharm D

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: June 1, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 12, 2018

Record last verified: 2015-12

Locations

US (1)