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NCT00332410 Clinical Trial

Intravenous Voriconazole in Patients With Renal Compromise

Renal Transplant Clinical Trial

Official title:
Intravenous Voriconazole in Patients With Renal Compromise

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00332410
Other study ID # IRB#0605055
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2006
Est. completion date December 2015

Study information
Verified date December 2015
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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. t has been previously shown by a large multi-centered, prospective, randomized study that voriconazole is superior to the then gold standard amphotericin B in the treatment of patients with invasive aspergillosis - a disease with significant morbidity and mortality. In patients with these infections who have severe renal insufficiency may be denied the best therapy due to the accumulation of a diluent with unknown clinical consequences. Qualifying and or quantifying these consequences are important to these patients so that potentially life-threatening therapy should not be unduly denied.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pittsburgh Pfizer

Country where clinical trial is conducted

United States, 

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