Status:
UNKNOWN
Trial of Rituximab Given Pre-Transplant to Sensitised Live Donor Kidney Recipients
Lead Sponsor:
Hunter and New England Health
Collaborating Sponsors:
Melbourne Health
Princess Alexandra Hospital, Brisbane, Australia
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 whe...
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 thera...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects, age \> 18 years
- Subjects receiving a single organ renal transplant from a living donor
- 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.
- 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):
- Primary renal transplant lost from acute rejection less than six months prior to randomisation
- Women of childbearing potential with a positive serum or urine pregnancy test or nursing mothers
- Subjects with history of malignancy (other than non melanoma skin cancer that has been totally excised with no recurrence for two years)
- Subjects with known contraindications to treatment with rituximab
- 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
- Subjects with a positive ABO crossmatch with donor
- 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
- 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
- Subjects who cannot be followed for the study duration
- 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:
- All exclusion criteria as at study entry
- Positive T- and/or B-cell CDC crossmatch at Day -2
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00371904
Start Date
April 1 2006
End Date
January 1 2009
Last Update
May 21 2008
Active Locations (3)
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1
Newcastle Transplant Unit, John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
2
Monash Medical Centre
Clayton, Victoria, Australia, 3168
3
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3052