Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation

NCT00568477 | Terminated Phase 2 DMC

• 2 other identifiers: VAL-518-HEE-0200-SEudraCT-number: 2006-006137-41
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rituximab, Heemannn

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Renal function at 1 year

  Graft survival at 1 and 2 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Treatment with rituximab

Drug: MabThera

Arm 2

NO INTERVENTION

Treatment without rituximab

Interventions

MabThera DRUG

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 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Technical University of Munich

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Uwe Heemann, Prof. MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: December 1, 2007
• Study Completion: December 1, 2010
• Last Updated: October 1, 2009

Record last verified: 2008-01

Locations

DE (1)