Official Title: “Intravenous Voriconazole in Patients With Renal Compromise”

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.

Study Type: Observational

Study Design: Other, Prospective

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.

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:

• None

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Brian Potoski, Pharm D Principal Investigator University of Pittsburgh  

Overall Contact: Brian Potoski, Pharm D 412-648-6401 potoskiba@upmc.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00332410

Study ID Number: IRB#0605055

ClinicalTrials.gov Identifier: NCT00332410

Health Authority: United States: Institutional Review Board