Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Completed · Phase 3

Conditions studied: Aspergillosis, Invasive Fungal Infections

In brief

The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

Key facts

Study ID

NCT00634049

Run by

Astellas Pharma Inc

People needed

149

Starts

2008-04-22

Expected to finish

2016-05-05

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants meeting EORTC/MSG (European Organization for the Research and Treatment of Cancer/Mycoses Study Group) definition of proven or culture positive probable IFD (invasive fungal disease) caused by rare moulds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment.
• OR
• Participants who had proven or probable zygomycosis, whether renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology.
• OR
• Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were refractory to current treatment defined as,
• Clear documentation of progression of disease. Note: radiological progression only in association with white blood cell (WBC) count recovery was not acceptable.
• Failure to improve clinically despite receiving at least 7 days of standard antifungal regimen. Prior to enrolling patients who fell into this category, the Medical Monitor was contacted for approval.
• OR
• Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were intolerant to current treatment for example:
• Doubling of serum creatinine value to higher than the upper limit of normal (ULN) within 48 hours.
• Serum creatinine > 2.0 mg/mL and current treatment with polyene or IV voriconazole.
• Other significant drug-related adverse reaction(s) to the current antifungal agent, resulting in discontinuation of the treatment, e.g., persistence of visual disturbance, allergic reaction, phototoxicity or severe infusion reaction (hypertensive crisis, severe chills or shock).
• Documented inability to achieve adequate blood levels of posaconazole, voriconazole or itraconazole.

You may not qualify if…

• A known condition of the participants that may jeopardize adherence to the protocol requirements
• Participants who are unlikely to survive 30 days
• Participants with a body weight < 40 kg
• Women who are pregnant or breastfeeding

Where it is running

• City Of Hope National Medical Center — Duarte, California, United States
• University of California Davis Health System — Sacramento, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Stanford University Hospital — Stanford, California, United States
• University Of Colorado Health Sciences Center — Aurora, Colorado, United States
• Emory Hospital — Atlanta, Georgia, United States
• University of Chicago, Division of Infectious Diseases — Chicago, Illinois, United States
• Indiana BMT — Beech Grove, Indiana, United States
• Infectious Disease of Indiana — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Brigham & Womens Hospital — Boston, Massachusetts, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• Wayne State University School of Medicine — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Upstate Infectious Diseases Association LLP — Albany, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Regional Infection Diseases Infusion Center Inc. — Lima, Ohio, United States
• Temple University Health Sciences — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center Health System — Pittsburgh, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center, Clinical Research — Seattle, Washington, United States
• Hospital Italiano de Buenos Aires — Ciudad Autonoma, Argentina
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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