Trial document





This trial has been registered retrospectively.
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  DRKS00009364

Trial Description

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Title

The course of therapy, safety and pharmacokinetic parameters of conversion of Prograf® to Tacrolimus Hexal®/Crilomus® in renal transplant recipients – an observational study in Germany

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study describes the course of therapy, the safety profile and pharmacokinetic Parameters from conversion of Prograf® to Tacrolimus Hexal®/Crilomus® in renal transplant recipients.

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Brief Summary in Scientific Language

Tacrolimus Hexal®/Crilomus® is an FDA and EMA approved generic for the prevention and treatment of rejection reactions in renal transplant recipients. So far, data on the conversion of Prograf® to Tacrolimus HEXAL®/Crilomus® were collected for several collectives of renal transplant patients especially in the US. First results point to the safety and efficacy of the conversion. To date, however, there is still an increased effort required (level measurements, visits to the doctor, blood samples) during a conversion, in order to ensure the safety of the patients.

For a safe and socioeconomically efficient conversion of Prograf® to Tacrolimus HEXAL®/Crilomus®, high quality data for larger patient collectives also in the EU and Germany are required. Proof of bioequivalence – even according to the more narrow criteria of the European drug agency for healthy subjects – is not sufficient in the opinion of the European expert committee of the ESOT. Different co-morbidities, medications and pharmacokinetics in transplant recipients make it necessary to collect further data for the above-mentioned patient collective.

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Organizational Data

  •   DRKS00009364
  •   2015/09/21
  •   [---]*
  •   no
  •   Approved
  •   EA1/106/14, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Prophylaxis of graft rejection
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Interventions/Observational Groups

  •   Tacrolimus HEXAL®/Crilomus® is used following the instructions in Ch. 4.2 of the summary of product characteristics. The study documents routinely collected clinical data and laboratory values over a priod of approx. 12 months.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Extension of the available information of the therapy with Tacrolimus HEXAL®/Crilomus® in routine clinical practice

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Secondary Outcome

Extension of available information on death, graft rejection, ofter conversion from Prograf to Tacrolimus HEXAL®/Crilomus®; extension of the available information on the tolerability profile of Tacrolimus HEXAL®/Crilomus®: documentation of adverse events


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/08/11
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- male and female patients >=18
- written informed consent
- time elapsed after Transplantation >= 6 month
- conversion from Prograf® to Tacrolimus HEXAL®/Crilomus®
- stable function of graft (S-Creatinine <3,5 mg/dL or <310 µmol/l)

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Exclusion Criteria

- Patient participating in interventional Trial
- known missing compliance of the Patient
- acute rejection during last 3 months or antibody medeated therapy against rejection during the last 6 month
- known active CMV or BKV replication
- active malignancies except basalioma or non-malignant Skin tumours
- known contraindication against application of Tacrolimus HEXAL®/Crilomus® according to SMPC
- for female patients: pregnancy or breast-feeding

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Addresses

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    • Hexal AG
    • Industriestr. 25
    • 83607  Holzkirchen
    • Germany
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    • Department of Nephrology, Charite Campus Mitte, Charité Universitätsmedizin Berlin
    • Mr.  Dr.  L. J.  Lehner 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Institut Dr. Schauerte
    • Ms.  Caroline  Schneider 
    • Finkenstr. 7
    • 80333  München
    • Germany
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Sources of Monetary or Material Support

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    • Hexal AG
    • Industriestr. 25
    • 83607  Holzkirchen
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/07/20
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.