Intravenous Voriconazole in Patients With Renal Compromise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

NCT01084148

Uremic Xerosis

COMPLETED PHASE3

RECOVAC - Long Term Efficacy and Safety of COVID-19 (SARS-CoV-2) Vaccination in Kidney Disease Patients

NCT04841785

Covid19 SARS-CoV Infection Chronic Kidney Diseases

COMPLETED

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105

NCT03043482

Chronic-kidney Disease Stage 5D on Stable Hemodialysis

COMPLETED PHASE1

The REnal Patients COVID-19 VACcination Immune Response (RECOVAC IR) Study

NCT04741386

Covid19 Chronic Kidney Diseases

COMPLETED

Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects

NCT00805090

Renal Insufficiency, Chronic Hepatic Insufficiency Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.