Intravenous Voriconazole in Patients With Renal Compromise
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Purpose
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.
| Condition |
|---|
|
Renal Transplant |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Intravenous Voriconazole in Patients With Renal Compromise |
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.
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2015 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
solid organ transplant receiving voriconazole with serum creatinine level >2
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
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Brian Potoski, Pharm D | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00332410 History of Changes |
| Other Study ID Numbers: | IRB#0605055 |
| Study First Received: | May 30, 2006 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Voriconazole renal transplant kidney function kidneys |
Additional relevant MeSH terms:
|
Voriconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013