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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00568477
Other study ID # VAL-518-HEE-0200-S
Secondary ID EudraCT-number:
Status Terminated
Phase Phase 2
First received December 5, 2007
Last updated September 30, 2009
Start date December 2007
Est. completion date December 2010

Study information

Verified date January 2008
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Germany Technical University of Munich Munich Bavaria

Sponsors (11)

Lead Sponsor Collaborator
Technische Universität München Heidelberg University, Heinrich-Heine University, Duesseldorf, Humboldt-Universität zu Berlin, Martin-Luther-Universität Halle-Wittenberg, Transplantationszentrum Köln-Merheim, University Hospital Freiburg, University Hospital, Essen, University of Erlangen-Nürnberg, University of Jena, University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Graft survival at 1 and 2 years No
Secondary Renal function at 1 year Graft survival at 1 and 2 years No
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