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Trial of Rituximab Given Pre-Transplant to Sensitised Live Donor Kidney Recipients

NCT ID: NCT00371904

Last Updated: 2008-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-01-31

Brief Summary

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About one third of prospective kidney transplant recipients have antibodies in their blood directed against the tissues of their only available kidney donor. Recently, "desensitisation" treatments when administered pre-transplant have allowed successful transplantation of these patients despite high rates of acute antibody mediated rejection (AAMR). The investigators propose to test in a randomised controlled trial whether rituximab, a monoclonal antibody that depletes B-lymphocytes, will safely lower antibody mediated rejection (AMR) rates when added to "standard" therapy. The investigators will also test whether rituximab enables more patients to achieve a negative crossmatch against their donor and thereby allow more transplants to proceed.

Detailed Description

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This study is designed to investigate in a prospective, randomised fashion whether a single intravenous dose of rituximab (375 mg/m2) given two weeks prior to transplant, in addition to standard therapy, will allow sensitised renal transplant subjects to achieve a negative CDC crossmatch and thereby proceed to live donor transplantation. We will also evaluate whether rituximab will reduce the number of AAMR episodes in the post-transplant period, compared to controls. All eligible subjects must have a positive T- and/or B-cell CDC or flow cytometry crossmatch and have donor-specific antibodies identified by solid-phase assay at screening. All subjects will receive a standard desensitisation regimen that includes plasma exchange/IVIG + MMF before and immediately after transplantation followed by a standard care immunosuppressive regimen (IL-2R antagonist, tacrolimus, mycophenolate mofetil \[MMF\] and corticosteroids) after transplantation.

Conditions

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Kidney Transplantation

Keywords

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Rituximab donor sensitised antibody rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation

2

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type DRUG

Standard care

Interventions

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Rituximab

Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation

Intervention Type DRUG

Standard Care

Standard care

Intervention Type DRUG

Other Intervention Names

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Mabthera

Eligibility Criteria

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Inclusion Criteria

1. Subjects, age \> 18 years
2. Subjects receiving a single organ renal transplant from a living donor
3. Positive T-cell and/or B-cell crossmatch by complement dependent cytotoxicity (CDC) and/or positive flow cytometry crossmatch with confirmed donor-specific antibodies on solid-phase assay at screening. Positive CDC T-cell and/or B-cell crossmatch titre must be less than or equal to 1:64.
4. Subjects capable of understanding the purposes and risks of the study and who can give written informed consent

Exclusion Criteria

1. Primary renal transplant lost from acute rejection less than six months prior to randomisation
2. Women of childbearing potential with a positive serum or urine pregnancy test or nursing mothers
3. Subjects with history of malignancy (other than non melanoma skin cancer that has been totally excised with no recurrence for two years)
4. Subjects with known contraindications to treatment with rituximab
5. Subjects with haemoglobin \< 8.5 g/dL, WBC value of \< 3000/mm3 or a platelet count of \< 50,000/mm3 that is unlikely to resolve prior to randomisation
6. Subjects with a positive ABO crossmatch with donor
7. Subjects with severe diarrhoea or other gastrointestinal disorders that might interfere with the ability to absorb oral medication and is unlikely to resolve prior to randomisation
8. Subjects participating in another interventional clinical trial or requiring treatment with un-marketed investigational drugs or who would be expected to require other medications prohibited by the protocol
9. Subjects who cannot be followed for the study duration
10. Subjects with disorders or conditions that may interfere with the ability to comply with study procedures and/or requirements


2. Positive T- and/or B-cell CDC crossmatch at Day -2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melbourne Health

OTHER

Sponsor Role collaborator

Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role collaborator

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role collaborator

Auckland City Hospital

OTHER_GOV

Sponsor Role collaborator

Monash Medical Centre

OTHER

Sponsor Role collaborator

Royal Perth Hospital

OTHER

Sponsor Role collaborator

Westmead Hospital

UNKNOWN

Sponsor Role collaborator

Royal Adelaide Hospital

OTHER

Sponsor Role collaborator

Hunter and New England Health

OTHER

Sponsor Role lead

Principal Investigators

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Paul R Trevillian, MBBS, FRACP

Role: STUDY_CHAIR

Newcastle Transplant Unit, John Hunter Hospital

Solomon Cohney, MBBS, FRACP, PhD

Role: STUDY_CHAIR

Melbourne Health

Locations

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Newcastle Transplant Unit, John Hunter Hospital

Newcastle, New South Wales, Australia

Site Status RECRUITING

Monash Medical Centre

Clayton, Victoria, Australia

Site Status NOT_YET_RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status NOT_YET_RECRUITING

Countries

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Australia

Central Contacts

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Paul R Trevillian, MBBS, FRACP

Role: CONTACT

Phone: +61414417311

Email: [email protected]

Solomon Cohney, MBBS, FRACP, PhD

Role: CONTACT

Phone: +61393427159

Email: [email protected]

Facility Contacts

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Paul R Trevillian, MBBS, FRACP

Role: primary

Ann Stein, RN

Role: backup

John Kanellis, MBBS, PhD, FRACP

Role: primary

Janet Andrew

Role: backup

Shlomo Cohney, MBBS

Role: primary

Maria Farrell

Role: backup

Other Identifiers

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RAPTURE

Identifier Type: -

Identifier Source: org_study_id