Intravenous Voriconazole in Patients With Renal Compromise
Sponsor: Pfizer
A observational or N/A phase clinical study on Renal Transplant, this trial is completed. The trial is conducted by Pfizer and has accumulated 11 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
11 versions recorded-
Sep 2024 — Present [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Dec 2021 — Jul 2024 [monthly]
Completed
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Jan 2021 — Dec 2021 [monthly]
Completed
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Nov 2020 — Jan 2021 [monthly]
Completed
▶ Show 6 earlier versions
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Jul 2018 — Nov 2020 [monthly]
Completed
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Jun 2018 — Jul 2018 [monthly]
Completed
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May 2018 — Jun 2018 [monthly]
Completed
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Apr 2018 — May 2018 [monthly]
Completed
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Completed NA
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Jan 2017 — Aug 2017 [monthly]
Completed NA
First recorded
May 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Pfizer
- University of Pittsburgh
For direct contact, visit the study record on ClinicalTrials.gov .