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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Hannover Medical School
Hanover, Lower Saxony, Germany
Universitätsklinikum der RWTH Aachen Medizinische Klinik II
Aachen, Germany
Charité Campus Mitte Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Köln Medizinische Klinik IV Nephrologie
Cologne, Germany
Kliniken der Stadt Köln gGmbH Medizinische Klinik I
Cologne, Germany
Universitätsklinikum Düsseldorf Klinik für Nephrologie
Düsseldorf, Germany
Universitätsklinikum Erlangen Nephrologie und Hypertensiologie
Erlangen, Germany
Universitätsklinikum Essen Klinik für Nephrologie
Essen, Germany
Universitätsklinikum Freiburg Medzinische Klinik IV Nephrologie Freiburg
Freiburg im Breisgau, Germany
Nephrologisches Zentrum Niedersachsen 34346 Hannoversch Münden
Hannoversch Münden, Germany
...and 4 more locations
Change of the GFR (glomerular filtration rate) one year after intervention compared to the baseline GFR before the rejection, which is calculated by a defined algorithm
Time frame: Baseline, 1 year
Progression of interstitial fibrosis and tubular atrophy between the biopsy that led to enrolment in the study and a scheduled protocol biopsy one year after intervention ("∆IFTA-Score")
Time frame: 1 year
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