Kidney Transplantation Clinical Trial
Official title:
Effectiveness and Safety of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy for Prevention of Graft Rejection Compared to Tacrolimus in Combination With MMF and Steroids in Cadaveric Kidney Transplantation
The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).
Major advances in immunosuppressive therapy have resulted in long-term graft survival by the
use of various drug combinations.However, these combinations carry the risk of e.g.
infection, malignancy, renal damage, hypertension, diabetes, hyperlipidemia, hirsutism,
cushingoid facial appearance and bone necrosis.Therefore one of the major goals should be to
reduce immunosuppression without increasing risk of rejections.
Based on good results of a pilot study (not a single acute rejection episode during the
18-20 months observation period despite low level of Tacrolimus and absence of steroids)
this randomised trial was designed to further evaluate the safety and efficacy of
Campath-1H.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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