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TerminatedNCT00568477Rituximab 2006Updated Oct 1, 2009

Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation

A Phase 2 interventional study of MabThera in Grafting, Renal Transplantation and Transplantation, Kidney, sponsored by Technical University of Munich. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-01.

Sponsored by Technical University of Munich · Phase 2, Interventional, and Treatment

Why this study was terminated
lacking recruitment
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Rituximab, Heemannn
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Arm 1

    Treatment with rituximab

    Drug: MabThera

  • No intervention
    Arm 2

    Treatment without rituximab

Interventions

  • DrugMabThera

    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

06

What researchers measure

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

    Time frame: Graft survival at 1 and 2 years

Secondary outcomes

  1. Renal function at 1 year

    Time frame: Graft survival at 1 and 2 years

07

Study locations

1 site
  • Technical University of Munich
    Munich, Bavaria 81675, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00568477
Lead sponsor
Technical University of Munich
Collaborators
Humboldt-Universität zu Berlin, University of Erlangen-Nürnberg, University Hospital, Essen, University Hospital Freiburg, Heidelberg University, University of Jena, Transplantationszentrum Köln-Merheim, University of Regensburg, Heinrich-Heine University, Duesseldorf, Martin-Luther-Universität Halle-Wittenberg
First posted
Dec 6, 2007
Start date
Dec 2007
Completion
Dec 2010 (estimated)
Last update
Oct 1, 2009

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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