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

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ClinicalTrials.gov Identifier: NCT00371904
Recruitment Status : Unknown
Verified May 2008 by Hunter and New England Health.
Recruitment status was:  Recruiting
First Posted : September 4, 2006
Last Update Posted : May 21, 2008
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: Rituximab Drug: Standard Care Phase 2

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : April 2006
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Rituximab
Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation
Other Name: Mabthera
Active Comparator: 2 Drug: Standard Care
Standard care

Outcome Measures

Primary Outcome Measures :
  1. Biopsy proven antibody mediated rejection [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Elimination of donor specific antibodies (DSA) [ Time Frame: Day - 2 , 7; Months 1, 3, 6, 9 and 12 ]
  2. C4d in biopsies [ Time Frame: Day 7; Months 3 and 12 ]
  3. Plasma exchanges [ Time Frame: Month 12 ]
  4. Death [ Time Frame: Month 12 ]
  5. Treated rejection [ Time Frame: Month 12 ]
  6. Graft loss [ Time Frame: Months 3, 6 and 12 ]
  7. Treatment failure [ Time Frame: Months 6 and 12 ]
  8. Calculation of glomerular filtration rate (GFR) [ Time Frame: Months 1 - 12 ]
  9. Slope of 1/serum creatinine (Ser. Cr) [ Time Frame: Months 6 and 12 ]
  10. 24-hour U protein [ Time Frame: Months 3 and 12 ]
  11. Safety [ Time Frame: Month 12 ]
  12. Cancer and infections [ Time Frame: Month 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 at Study Entry (4 weeks prior to transplant):

  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

Additional Exclusion Criteria at Day -2 before Transplantation:

  1. All exclusion criteria as at study entry
  2. Positive T- and/or B-cell CDC crossmatch at Day -2
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371904

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
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         
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         
Sponsors and Collaborators
Hunter and New England Health
Melbourne Health
Princess Alexandra Hospital, Brisbane, Australia
Royal Prince Alfred Hospital, Sydney, Australia
Auckland City Hospital
Monash Medical Centre
Royal Perth Hospital
Westmead Hospital
Royal Adelaide Hospital
Study Chair: Paul R Trevillian, MBBS, FRACP Newcastle Transplant Unit, John Hunter Hospital
Study Chair: Solomon Cohney, MBBS, FRACP, PhD Melbourne Health
More Information

ClinicalTrials.gov Identifier: NCT00371904     History of Changes
Other Study ID Numbers: RAPTURE
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

Keywords provided by Hunter and New England Health:

Additional relevant MeSH terms:
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents