Intravenous Voriconazole in Patients With Renal Compromise

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00332410
First received: May 30, 2006
Last updated: August 23, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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.


Estimated Enrollment: 150
Study Start Date: May 2006
Estimated Study Completion Date: December 2015
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

solid organ transplant receiving voriconazole with serum creatinine level >2

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332410

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Pfizer
Investigators
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
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014