Renal Transplantation Clinical Trial
Official title:
Prospective, Randomized, Open, 2-arm National Multi-center Study to Evaluate the Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation.
To evaluate the benefit of rituximab in patients with CAN with histologically proven C4d deposits and/or plasma cell and/or B-Lymphocyte (CD20+ cells) infiltration of their grafts.
This study is a prospective, randomized, open, 2-arm, national multi-center study to
evaluate the value of rituximab in humoral chronic rejection after renal transplantation in
approximately 150-200 patients (75-100 patients each group).
All biopsies will be analysed by Prof. Groene (Heidelberg) and the results immediately
communicated to the central managing unit (Munich). Upon receipt, patients with biopsy
proven CAN with C4d+ and/or plasma-cells and/or B-lymphocytes within the last 4 weeks before
inclusion (centrally confirmed), fulfilling the inclusion/exclusion criteria, will be
randomized 1:1 into one of the 2 groups:
Arm 1: Treatment with rituximab Arm 2: Treatment without rituximab Recruitment will last for
approximately one year. All patients will be treated with baseline medication of Tacrolimus,
MMF, steroids (optional, with same dose as given before study entry) and ACE-inhibitor or
AT1-receptor-antagonist. A single dose of 100 mg Methylprednisolone i.v. will be given at
baseline (day 0) in both groups (in the rituximab group 30 min before start of the rituximab
infusion).
Each patient will be followed for 1 year within protocol, with study visits at 1,3,7 and 14
days (rituximab group), 3, 6 and 12 months followed by a follow-up period of 1 year with a
study visit at 24 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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