CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years
has substantially reduced the risk of rejection after kidney transplantation, has allowed the
development of immuno-suppressive regimens that do not use long-term steroids (steroid
avoidance), and has improved transplant success rates both in the short and medium term.
The main new agents used in these modern regimens are the calcineurin inhibitor (CNI)
tacrolimus; the anti-proliferative agent mycophenolate; and induction agents which are used
to provide effective early suppression of the rejection process; these include monoclonal
antibodies (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and
daclizumab) and the anti-CD52 antibody Campath-1H (alemtuzumab).
Although almost all modern immunosuppressive regimens involve one or more of these agents, it
is not known which is the safest and most effective combination.
This randomised controlled trial compares two steroid sparing regimens which have been used
with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit
over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is
as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.