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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00634049




Registration number
NCT00634049
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008

Titles & IDs
Public title
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Scientific title
Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi
Secondary ID [1] 0 0
WSA-CS-003
Secondary ID [2] 0 0
9766-CL-0103
Universal Trial Number (UTN)
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspergillosis 0 0
Invasive Fungal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - isavuconazole

Experimental: Isavuconazole - Administration of isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days followed by daily administration of isavuconazole (IV) or oral


Treatment: Drugs: isavuconazole
Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
Timepoint [1] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [1] 0 0
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Timepoint [1] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [2] 0 0
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Timepoint [2] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [3] 0 0
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Timepoint [3] 0 0
Day 42, 84 and End of Treatment (EOT [Day 180])
Secondary outcome [4] 0 0
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Timepoint [4] 0 0
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Secondary outcome [5] 0 0
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Timepoint [5] 0 0
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Secondary outcome [6] 0 0
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Timepoint [6] 0 0
Day 42, Day 84 and End of Treatment (EOT [Day 180])
Secondary outcome [7] 0 0
All-cause Mortality Through Day 42 and Day 84
Timepoint [7] 0 0
Baseline to End of Treatment (EOT [Day 180])
Secondary outcome [8] 0 0
Safety - Overall Number of TEAEs
Timepoint [8] 0 0
From the first study drug administration until 28 days after the last dose of study drug

Eligibility
Key inclusion criteria
•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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/05/2016
Sample size
Target
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mater Medical Centre - South Brisbane
Recruitment hospital [2] 0 0
Princess Alexandria Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Georgia
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Illinois
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Indiana
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United States of America
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Louisiana
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United States of America
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Massachusetts
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Michigan
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United States of America
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Minnesota
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New York
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Ohio
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Ciudad Autonoma
Country [17] 0 0
Argentina
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Cordoba
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Argentina
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San Juan
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Brazil
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Belo Horizonte
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Brazil
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Curitiba
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro
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Brazil
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Santa Maria
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Brazil
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São Paulo
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Canada
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Ontario
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Canada
State/province [30] 0 0
Quebec
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Chile
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Santiago
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Egypt
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Alexandria
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Egypt
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Cairo
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France
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Lyon cedex 3
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France
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Marseille Cedex 9
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France
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Nantes
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France
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Paris Cedex 10
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France
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Strasbourg Cedex
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France
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Vandoeuvre les Nancy
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Köln
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Germany
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Muenchen
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Germany
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Würzburg
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India
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Haryan
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India
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Kama
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India
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Mahara
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India
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Tamilna
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India
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Ahmedabad
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India
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Hyderabad
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India
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Pune
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Korea, Republic of
State/province [57] 0 0
Buchon-si
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Korea, Republic of
State/province [58] 0 0
Incheon
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Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Lebanon
State/province [60] 0 0
Beirut
Country [61] 0 0
Mexico
State/province [61] 0 0
Guadalajara
Country [62] 0 0
Mexico
State/province [62] 0 0
Mexico City
Country [63] 0 0
Mexico
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Monterrey
Country [64] 0 0
Mexico
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San Luis Potosi
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Poland
State/province [65] 0 0
Warszawa
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Petrozavodsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
St. Petersburg
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South Africa
State/province [69] 0 0
Gauteng
Country [70] 0 0
Thailand
State/province [70] 0 0
Hat Yai
Country [71] 0 0
Thailand
State/province [71] 0 0
Muang
Country [72] 0 0
Thailand
State/province [72] 0 0
Ratchathewi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Basilea Pharmaceutica International Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00634049