Trial document




This trial has been registered retrospectively.
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  DRKS00000011

Trial Description

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Title

A prospective randomized trial on CellCept© (Mycophenolat Mofetil) in risk penetrating keratoplasty

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of CellCept© (Mycophenolat Mofetil) for prevention of graft rejections following risk penetrating keratoplasty.

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Brief Summary in Scientific Language

Evaluation of CellCept© (Mycophenolat Mofetil) for preventing graft rejections following risk penetrating keratoplasty.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000011
  •   2008/09/05
  •   2006/06/27
  •   no
  •   Approved
  •   116/00, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT00411515  (ClinicalTrials.gov)
  •   UKF000727  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   H44.5 -  Degenerated conditions of globe
  •   CellCept
  •   5-125: null
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Interventions/Observational Groups

  •   The patients of the MMF group receive MMF orally 2x1 g daily for 6 months.
  •   No systemic immunosuppression
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Other
  •   Parallel
  •   IV
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Primary Outcome

Endpoints were immune reaction free and clear graft survival and the occurence of side-effects

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2000/09/13
  •   140
  •   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

Keratoplasty with increased risk for immunologic graft rejection in the abscence of other risk factors for graft failure. (repeat keratoplasty, steroid-response, limbo-keratoplasty, oversized graft.

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Exclusion Criteria

Normal risk cases. Herpes-Keratitis. Glaucoma. Limbus stem cell deficiency.

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Addresses

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    • Hoffmann-La Roche AG
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    • Universitätsklinikum Freiburg Ophthalmologie
    • Mr.  Prof. Dr. med.  Thomas  Reinhard 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Ophthalmologie
    • Mr.  Prof. Dr.  Thomas  Reinhard 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Hoffmann-La Roche AG
    • 79639  Grenzach-Wyhlen
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Status

  •   Recruiting complete, follow-up complete
  •   2006/05/01
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Trial Publications, Results and other Documents

  •   Birnbaum F, Mayweg S, Reis A, Böhringer D, Seitz B, Engelmann K, Messmer EM, Reinhard T. (2009) Mycophenolate mofetil (MMF) following penetrating high risk keratoplasty – long-term results of a prospective, randomised, multicentre study. Eye Nov;23(11):2063-70.
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* This entry means the parameter is not applicable or has not been set.