Evaluating the safety and efficacy of mycophenolate mofetil, daclizumab and a single, initial week of corticosteroids in combination with tacrolimus or sirolimus with continued steroid as mainstay immunosuppression in comparison to current standard immunosuppression (mycophenolate mofetil, tacrolimus and continued corticosteroids) in renal transplantation.

Registry ID
EUCTR2004-005055-33
Source registry
EUCTR
Status
Prematurely Ended
Phase
PHASE4
Sponsor
Barts and the London NHS Trust
Start date
2005-02-10
Completion date
2005-02-10
Last update
2026-08-16

Conditions

Summary

The primary objective of the present investigation is to compare the incidence or avoidance of corticosteroid use, as a measure of the decreased incidence of acute rejection episodes 6 and 12 months after primary renal transplantation in patients receiving three different immunosuppressive treatments. Current standard immunosuppression (group A: mycophenolate mofetil, tacrolimus and corticosteroids) will be compared to regimens with mycophenolate mofetil, daclizumab and a single week of corticosteroids as mainstay immunosuppression in combination with tacrolimus (group B) or (group C) where sirolimus, MMF and steroids will be continued.

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