Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007350

Trial Description

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Title

A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study was to offer patients who had participated in one of the phase II
PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until
commercial availability of the drug and to record long term efficacy and safety data.

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Brief Summary in Scientific Language

Only patients who have participated in one of the phase II PK or phase III studies on FK506E
(MR4) and have received at least one dose of study medication will be enrolled.

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Organizational Data

  •   DRKS00007350
  •   2016/03/11
  •   2014/04/17
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2005-005714-20 
  •   NCT02118896  (ClinicalTrials.gov)
  •   F506-CL-0857  (Astellas Pharma Europe Ltd.)
  •   2005-005714-20 
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Health Condition or Problem studied

  •   Kidney Transplantation
  •   Liver Transplantation
  •   Heart Transplantation
  •   Z94.0 -  Kidney transplant status
  •   Z94.1 -  Heart transplant status
  •   Z94.4 -  Liver transplant status
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Interventions/Observational Groups

  •   Drug: FK506E
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
  •   [---]*
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Primary Outcome

- Patient survival; time frame: Duration of study participation up to 6 years (i.e. until study ends or study drug is available commercially in the country)
- Graft survival; time frame: Duration of study participation up to 6 years (i.e. until study ends or study drug is available commercially in the country)

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Secondary Outcome

- Incidence of first biopsy-proven acute rejection episodes; time frame: Duration of study participation up to 6 years (i.e. until study ends or study drug is available commercially in the country)
- Time to first biopsy-proven acute rejection episodes; time frame: Duration of study participation up to 6 years (i.e. until study ends or study drug is available commercially in the country)
- Incidence of adverse events; time frame: Duration of study participation up to 6 years (i.e. until study ends or study drug is available commercially in the country)

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Canada
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Hungary
  •   Ireland
  •   Italy
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Poland
  •   South Africa
  •   Spain
  •   Sweden
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2003/01/31
  •   850
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Patients who had already participated in the previous phase II pharmacokinetic or
phase III studies with FK506E (MR4).

- Patients capable of understanding the purpose and risks of the study, who have been
fully informed and given written informed consent to participate in the study.

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Exclusion Criteria

- Pregnant women or nursing mothers.

- Women unwilling or unable to use adequate contraception during the study.

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Addresses

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    • Astellas Pharma Europe Ltd.
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Astellas Pharma Europe Ltd.
    • Central Contact 
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Astellas Pharma Europe Ltd.
    • Central Contact 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2009/10/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.