Efficacy of Rituximab in Acute Cellular Rejection in Renal Transplant Patients
- Registration Number
- NCT01117662
- Lead Sponsor
- Hannover Medical School
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo Intravenous application of placebo (NaCl 0,9 %) matching active treatment Rituximab Rituximab Intravenous application of Rituximab 375mg/m² body surface in 250 ml NaCl 0,9 % over 4 hours
- Primary Outcome Measures
Name Time Method 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 Baseline, 1 year
- Secondary Outcome Measures
Name Time Method 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") 1 year
Trial Locations
- Locations (14)
Universitätsklinikum Münster Innere Medizin / Nephrologie
🇩🇪Münster, Germany
Nephrologisches Zentrum Niedersachsen 34346 Hannoversch Münden
🇩🇪Hannoversch Münden, Germany
Universitätsklinikum Jena Klinik für Innere Medizin III
🇩🇪Jena, Germany
Universitätsklinikum Düsseldorf Klinik für Nephrologie
🇩🇪Düsseldorf, Germany
Charité Campus Mitte Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Universitätsklinikum der RWTH Aachen Medizinische Klinik II
🇩🇪Aachen, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel Klinik für Nieren- und Hochdruckkrankheiten Kiel
🇩🇪Kiel, Germany
Hannover Medical School
🇩🇪Hannover, Lower Saxony, Germany
Universitätsklinikum Erlangen Nephrologie und Hypertensiologie
🇩🇪Erlangen, Germany
Universitätsklinikum Freiburg Medzinische Klinik IV Nephrologie Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Essen Klinik für Nephrologie
🇩🇪Essen, Germany
Universitätsklinikum Köln Medizinische Klinik IV Nephrologie
🇩🇪Köln, Germany
Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Uniklinik München Klinikum Großhadern
🇩🇪München, Germany
Kliniken der Stadt Köln gGmbH Medizinische Klinik I
🇩🇪Köln, Germany