deltatrials
Completed OBSERVATIONAL NCT00332410

Intravenous Voriconazole in Patients With Renal Compromise

Sponsor: Pfizer

Updated 11 times since 2017 Last updated: Jun 11, 2018 Started: May 31, 2006 Primary completion: Dec 31, 2015 Completion: Dec 31, 2015

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

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotCompleted~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshotCompleted~Apr 2018 – ~May 2018 · 30 days · monthly snapshotCompleted~May 2018 – ~Jun 2018 · 31 days · monthly snapshotCompleted~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotCompleted~Jul 2018 – ~Nov 2020 · 28 months · monthly snapshotCompleted~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Dec 2021 — Jul 2024 [monthly]

    Completed

  4. Jan 2021 — Dec 2021 [monthly]

    Completed

  5. Nov 2020 — Jan 2021 [monthly]

    Completed

Show 6 earlier versions
  1. Jul 2018 — Nov 2020 [monthly]

    Completed

  2. Jun 2018 — Jul 2018 [monthly]

    Completed

  3. May 2018 — Jun 2018 [monthly]

    Completed

  4. Apr 2018 — May 2018 [monthly]

    Completed

    Phase: NANone

  5. Aug 2017 — Apr 2018 [monthly]

    Completed NA

  6. 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

Sponsor contact:
  • Pfizer
  • University of Pittsburgh
Data source: University of Pittsburgh

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations