Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation - Full Text View

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

This study is currently recruiting participants.

Verified by Technische Universität München, January 2008

Sponsors and Collaborators:	Technische Universität München Humboldt-Universität zu Berlin University of Erlangen-Nürnberg University Hospital, Essen University Hospital Freiburg University of Heidelberg University of Jena Transplantationszentrum Köln-Merheim University of Regensburg Heinrich-Heine University, Duesseldorf Martin-Luther-Universität Halle-Wittenberg
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00568477

Purpose

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.

Condition	Intervention	Phase
Grafting Renal Transplantation Transplantation, Kidney Chronic Allograft Nephropathy	Drug: MabThera	Phase II

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective, Randomized, Open, 2-Arm National Multi-Center Study to Evaluate the Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation.

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Renal function at 1 year [ Time Frame: Graft survival at 1 and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
Arm 1: Experimental 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
Arm 2: No Intervention Treatment without rituximab

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568477

Contacts

Contact: Uwe Heemann, Prof. MD	+49(89)41402231	Uwe.Heemann@lrz.tu-muenchen.de
Contact: Annette Schuster	+49(89)4140 6323	annette.schuster@lrz.tu-muenchen.de

Locations

Germany, Bavaria
Technical University of Munich	Recruiting
Munich, Bavaria, Germany, 81675
Contact: Annette Schuster +49(89)4140-6325 annette.schuster@lrz.tu-muenchen.de
Contact: Jens Lutz, MD +49(89)4140-4840 Jens.Lutz@lrz.tum.de
Sub-Investigator: Jens Lutz, MD

Sponsors and Collaborators

Technische Universität München

Humboldt-Universität zu Berlin

University of Erlangen-Nürnberg

University Hospital, Essen

University Hospital Freiburg

University of Heidelberg

University of Jena

Transplantationszentrum Köln-Merheim

University of Regensburg

Heinrich-Heine University, Duesseldorf

Martin-Luther-Universität Halle-Wittenberg

Investigators

Principal Investigator:

Uwe Heemann, Prof. MD

Technical University of Munich, Klinikum rechts der Isar; Münchner Studienzentrum

More Information

Responsible Party:	Technical University of Munich, Klinikum rechts der Isar ( Univ.-Prof. Dr. med. Dr. h.c. Uwe Heemann )
Study ID Numbers:	VAL-518-HEE-0200-S, EudraCT-number: 2006-006137-41
Study First Received:	December 5, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00568477
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:

Rituximab, Heemannn

Study placed in the following topic categories:

Rituximab
Kidney Diseases

Additional relevant MeSH terms:

Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009