Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000011

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000011
  •   2008/09/05
  •   2006/06/27
  •   no
  •   Approved
  •   116/00, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00411515  (ClinicalTrials.gov)
  •   UKF000727  (Register Klinischer Studien des Universitätsklinikums Freiburg)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   H44.5 -  Degenerated conditions of globe
  •   CellCept
  •   5-125: null
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The patients of the MMF group receive MMF orally 2x1 g daily for 6 months.
  •   No systemic immunosuppression
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Other
  •   Parallel
  •   IV
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2000/09/13
  •   140
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Hoffmann-La Roche AG
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg Ophthalmologie
    • Mr.  Prof. Dr. med.  Thomas  Reinhard 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg Ophthalmologie
    • Mr.  Prof. Dr.  Thomas  Reinhard 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Hoffmann-La Roche AG
    • 79639  Grenzach-Wyhlen
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2006/05/01
end of 1:1-Block state
start of 1:n-Block publications

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.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.