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Sponsors and Collaborators: |
Hunter and New England Health Melbourne Health Princess Alexandra Hospital, Brisbane, Australia Royal Prince Alfred Hospital, Sydney, Australia Auckland City Hospital, New Zealand Monash University Royal Perth Hospital Sydney West Area Health Service Royal Adelaide Hospital |
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Information provided by: | Hunter and New England Health |
ClinicalTrials.gov Identifier: | NCT00371904 |
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.
Condition | Intervention | Phase |
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Kidney Transplantation |
Drug: Rituximab Drug: Standard Care |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Open Label Randomised Multicentre Study Evaluating the Efficacy & Safety of Rituximab Given Pre-Transplant to Sensitised Renal Allograft Recipients in Addition to a "Standard" Desensitisation Regimen Consisting of PE/IVIG & MMF |
Estimated Enrollment: | 192 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Rituximab
Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation
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2: Active Comparator |
Drug: Standard Care
Standard care
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria at Study Entry (4 weeks prior to transplant):
Additional Exclusion Criteria at Day -2 before Transplantation:
Contact: Paul R Trevillian, MBBS, FRACP | +61414417311 | Paul.Trevillian@hnehealth.nsw.gov.au |
Contact: Solomon Cohney, MBBS, FRACP, PhD | +61393427159 | Solomon.Cohney@wh.org.au |
Australia, New South Wales | |
Newcastle Transplant Unit, John Hunter Hospital | Recruiting |
Newcastle, New South Wales, Australia, 2305 | |
Contact: Paul R Trevillian, MBBS, FRACP +61249214326 Paul.Trevillian@hnehealth.nsw.gov.au | |
Contact: Ann Stein, RN +61249214341 Ann.Stein@hnehealth.nsw.gov.au | |
Principal Investigator: Paul R Trevillian, MBBS, FRACP | |
Australia, Victoria | |
Royal Melbourne Hospital | Not yet recruiting |
Parkville, Victoria, Australia, 3052 | |
Contact: Shlomo Cohney, MBBS +61393427159 Solomon.Cohney@wh.org.au | |
Contact: Maria Farrell +61393427077 maria.farrell@mh.org.au | |
Principal Investigator: Shlomo Cohney, MBBS, PhD, FRACP | |
Monash Medical Centre | Not yet recruiting |
Clayton, Victoria, Australia, 3168 | |
Contact: John Kanellis, MBBS, PhD, FRACP +61395943070 john.kanellis@med.monash.edu.au | |
Contact: Janet Andrew +61395943526 j.andrew@southernhealth.org.au | |
Principal Investigator: John Kanellis, MBBS, PhD, FRACP |
Study Chair: | Paul R Trevillian, MBBS, FRACP | Newcastle Transplant Unit, John Hunter Hospital |
Study Chair: | Solomon Cohney, MBBS, FRACP, PhD | Melbourne Health |
Study ID Numbers: | RAPTURE |
Study First Received: | September 1, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00371904 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee |
Rituximab donor sensitised antibody rejection |
Antibodies Immunologic Factors Rituximab Antirheumatic Agents Immunoglobulins |
Immunologic Factors Antineoplastic Agents Rituximab Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |