Efficacy of Rituximab in Acute Cellular Rejection in Renal Transplant Patients
Status:
Terminated
Trial end date:
2016-08-23
Target enrollment:
Participant gender:
Summary
Acute kidney allograft rejection is the major cause for a loss of graft function and has a
negative impact on long-term graft survival. Anti-rejection therapy traditionally focuses on
T cell-mediated mechanisms of renal allograft rejection. However, available agents that
affect T-cell pathways have only little impact on long-term graft survival. There is
increasing evidence that B-cells play an important role in acute transplant rejections. CD20+
B cell infiltrates in acute T-cell mediated rejections are frequent and correlate with a
worse response to conventional anti-rejection treatment and an increased risk of graft loss.
In one pilot study, supported by several case reports, a beneficial effect of Rituximab for
the treatment of acute rejection episodes with intrarenal B-cell infiltrates was shown.
However, despite the promise of these observations solid evidence is required before
incorporating this treatment option into a general treatment recommendation.
In a multicenter randomized placebo controlled double blind phase III trial the investigators
want to demonstrate that Rituximab in addition to standard treatment with steroid-boli is
superior to the standard treatment alone regarding long-term kidney function. If the proposed
study proves that Rituximab treatment of acute rejections is beneficial for the long-term
allograft function, the conventional rejection therapy needs to be revised to this novel
concept of B- cell targeting