Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation (Rituximab 2006)
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.
Chronic Allograft Nephropathy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized, Open, 2-arm National Multi-center Study to Evaluate the Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation.|
- Primary objective: To evaluate the benefit of Rituximab in patients with CAN with histologically proven C4d deposits and/or B-Lymphocyte (CD20+ cells) infiltration of their grafts. Secondary objectives: Renal function at 1 year [ Time Frame: Graft survival at 1 and 2 years ] [ Designated as safety issue: No ]
- Renal function at 1 year [ Time Frame: Graft survival at 1 and 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||December 2010|
Experimental: Arm 1
Treatment with rituximab
375 mg/m² as IV infusions over >=6h each at time point 0 and 2 weeks. Initial infusion rate of 50 mg/h, stepwise rise is possible after 30 minutes
No Intervention: Arm 2
Treatment without rituximab
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.
|Technical University of Munich|
|Munich, Bavaria, Germany, 81675|
|Principal Investigator:||Uwe Heemann, Prof. MD||Technical University of Munich, Klinikum rechts der Isar; Münchner Studienzentrum|