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CompletedNCT00036179Updated Jan 10, 2018

Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

A Phase 2 interventional study of FK463 in Candidiasis, sponsored by Astellas Pharma Inc. Completed at 23 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Feb 1999, registered May 2002).
Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

Read the detailed description

This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

02

Conditions studied

  • Candidiasis

Keywords

  • Candidemia
  • Anti-Fungal
03

In context

Candidiasis

270 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's enrollment of 75 is below the median of 99 across 191 interventional studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.

Browse Astellas Pharma Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

Exclusion criteria

Exclusion Criteria

  • Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
  • Has life expectancy judged to be less than 5 days
  • De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =\< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis
  • Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Interventions

06

Study locations

23 sites
  • Medizinische Univ.-Klinik
    Graz, A 8036, Austria
  • Krankenhaus Elisabethinen Linz
    Linz, A-4010, Austria
  • Hopital Henri Mondor, Dervice d'Hematologie Clinique
    Créteil, 94010, France
  • Hotel Dieu, Service d"Hematologie
    Nantes, 44093, France
  • Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
    Paris, 10, France
  • Hopital Necker Enfants Malades, Service d"Hematologie
    Paris, 75015, France
  • Johann Wolfgang Goethe Universitat, Medizinische Klinik III
    Frankfurt, D-60590, Germany
  • Westpfalz Krankenhaus
    Kaiserslautern, D-67655, Germany
  • Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
    Leipzig, D-04103, Germany
  • Klinikum der Stadt, Medizinische Klinik A
    Ludwigshafen, D-67063, Germany
  • Uniklinik Mainz, III. Medizinische Klinik
    Mainz, 55101, Germany
  • LMU Munchen, Hamatopoetische Zell - Transplantation
    München, D-81366, Germany
  • Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
    Würzburg, D-97070, Germany
  • Nationale Institute for Cancer Research
    Genova, I 16132, Italy
  • Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
    Milan, 20162, Italy
  • Institute of Haematology and Blood Transfusion
    Warsaw, 00-957, Poland
  • Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas
    Barcelona, 28041, Spain
  • Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
    Madrid, ES 28007, Spain
  • Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas
    Madrid, ES 28041, Spain
  • Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
    Huddinge, SE141 86, Sweden
  • Royal Free Hospital, Dept. of Haematological Oncology
    London, NW3 2QG, United Kingdom
  • Christie Hospital NHS Trust
    Manchester, M20 4BX, United Kingdom
  • Royal Marsden Hospital
    Sutton Surrey, SM2 5PT, United Kingdom
07

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 1999 to primary completion in Jan 2002, 35 months.

Of 14 phase 2 interventional studies under Candidiasis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2002
First posted
May 9, 2002
StartActual
Feb 27, 1999
Primary completionActual
Jan 27, 2002
CompletionActual
Jan 27, 2002
Last update
Jan 10, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00036179
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
May 9, 2002
Start date
Feb 27, 1999
Primary completion
Jan 27, 2002
Completion
Jan 27, 2002
Last update
Jan 10, 2018
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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