GraftingPhase 2Rituximab 2006NCT00568477
Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation
A Phase 2 study testing MabThera in people with Grafting and Renal Transplantation, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grafting, Renal Transplantation, Transplantation, Kidney
- What is being tested?
- MabThera
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
- Being tested
- MabThera
- Keywords
- Rituximab, Heemannn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MabTheraDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Treatment with rituximab Receives: Drug: MabThera |
| Arm 2 | No intervention | Treatment without rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Graft survival at 1 and 2 years
Secondary outcomes (1)
Renal function at 1 year
Measured: Graft survival at 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startDec 2007
- Study completionDec 2010 (estimated)
Why it stopped: lacking recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GraftingStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Uwe Heemann, Prof. MD, Principal investigator, Technical University of Munich, Klinikum rechts der Isar; Münchner Studienzentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568477
- Sponsor's protocol ID
- VAL-518-HEE-0200-S
- Other IDs
- EudraCT-number: 2006-006137-41
- Acronym
- Rituximab 2006
- Status last verified
- Jan 2008
- First submitted
- 5 Dec 2007
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open, 2-arm National Multi-center Study to Evaluate the Value of Rituximab in Humoral Chronic Rejection After Renal Transplantation.
- ClinicalTrials.gov ID
- NCT00568477
- Acronym / sponsor ID
- Rituximab 2006 / VAL-518-HEE-0200-S
- Keywords
- Rituximab, Heemannn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lacking recruitment
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- 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
- Study start
- Dec 2007
- Study completion
- Dec 2010 (estimated)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: MabTheraTreatment with rituximab |
| Arm 2 | No intervention | –Treatment without rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MabTheraRituximab (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 | Drug | Arm 1 |
Primary outcome
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
1 secondary outcome
Renal function at 1 year
Time frame: Graft survival at 1 and 2 years
Results and safety
The study was stopped early (reason given: lacking recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Heemann, Prof. MD principal investigator
Technical University of Munich, Klinikum rechts der Isar; Münchner Studienzentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MabThera in people with Grafting and Renal Transplantation, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lacking recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009.