Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation (Rituximab 2006)

September 30, 2009 updated by: Technical University of Munich

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Technical University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Renal allograft recipients at least 1 year after transplantation with GFR > 25 ml/min x 1,73m2 (MDRD)
  • Single organ recipients of renal allograft
  • Patients who have provided informed consent
  • Patients who are >= 18 years of age
  • Patients who have biopsy proven CAN with C4d+ deposits and/or plasma-cells and/or B-lymphocytes within the last 4 weeks before inclusion
  • Patients who are treated with ACE/AT1 Blocker more than 1 week before inclusion

Exclusion Criteria:

  • Patients who suffer from HIV infection
  • Patients with a history of Hepatitis B
  • Patients with Hepatitis C (active/chronic)
  • Patients who have a contraindication for the use of rituximab, such as leukopenia or experienced infusion-related adverse events to former antibody treatment
  • Patients who showed signs of acute cellular rejection in the biopsy
  • Patient has a malignancy or history of malignancy within the last 5 years, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
  • Patient has a systemic infection requiring treatment.
  • Female patients who are pregnant or lactating
  • Patients who have any form of substance abuse, psychological illness or any other condition, which, in the opinion of the investigator, may interfere with the patient's ability to understand the requirements of the study.
  • Patients who have a proteinuria >4g/24h
  • Patient is unlikely to comply with the visits scheduled in the protocol.
  • Patient is simultaneously participating in another investigational drug study or has participated in such study within 28 days before entry in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Treatment with rituximab
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
No Intervention: Arm 2
Treatment without rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Graft survival at 1 and 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal function at 1 year
Time Frame: Graft survival at 1 and 2 years
Graft survival at 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

December 5, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

October 1, 2009

Last Update Submitted That Met QC Criteria

September 30, 2009

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAL-518-HEE-0200-S
  • EudraCT-number: 2006-006137-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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