Trial document
This trial has been registered retrospectively.
DRKS00000011
Trial Description
Title
A prospective randomized trial on CellCept© (Mycophenolat Mofetil) in risk penetrating keratoplasty
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.
Brief Summary in Scientific Language
Evaluation of CellCept© (Mycophenolat Mofetil) for preventing graft rejections following risk penetrating keratoplasty.
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
Secondary IDs
- NCT00411515 (ClinicalTrials.gov)
- UKF000727 (Register Klinischer Studien des Universitätsklinikums Freiburg)
Health Condition or Problem studied
- H44.5 - Degenerated conditions of globe
- CellCept
- 5-125: null
Interventions/Observational Groups
- The patients of the MMF group receive MMF orally 2x1 g daily for 6 months.
- No systemic immunosuppression
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
Secondary Outcome
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Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Actual
- 2000/09/13
- 140
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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.
Exclusion Criteria
Normal risk cases. Herpes-Keratitis. Glaucoma. Limbus stem cell deficiency.
Addresses
-
start of 1:1-Block address primary-sponsor
- Hoffmann-La Roche AG
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
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- http://www.roche.de/index.htm?sid=75386baff8814f375f23a401962a212b
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-contactstart of 1:1-Block address contact scientific-contact- +49 761 270-4001
- +49 761 270-4063
- thomas.reinhard at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/augenklinik/live/homede.html
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-contactstart of 1:1-Block address contact public-contact- +49 761 270-4001
- +49 761 270-4063
- thomas.reinhard at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/augenklinik/live/homede.html
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- +49 7624 14-0
- +49 7624 1019
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- http://www.roche.de/index.htm?sid=74edc683109514942246c4869810032a
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2006/05/01
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.