Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation

Summary

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.

Conditions

• Grafting
• Renal Transplantation
• Transplantation, Kidney
• Chronic Allograft Nephropathy

Interventions

DRUG

MabThera

Rituximab (MabThera): 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

Sponsors & Collaborators

• Humboldt-Universität zu Berlin

  collaborator OTHER

• University of Erlangen-Nürnberg

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• University of Jena

  collaborator OTHER

• Transplantationszentrum Köln-Merheim

  collaborator OTHER

• University of Regensburg

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• Technical University of Munich

  lead OTHER

Principal Investigators

• Uwe Heemann, Prof. MD · Technical University of Munich, Klinikum rechts der Isar; Münchner Studienzentrum

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Completion

2010-12-31

Countries

• Germany

Study Locations