Intravenous Voriconazole in Patients With Renal Compromise

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.

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 Investigator: University of Pittsburgh Other

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 February 12, 2012

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