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

Sponsor
Hunter and New England Health
Study ID
NCT00371904
Phase
PHASE2
Status
Unknown

Conditions

  • Kidney Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation
  • Standard Care — DRUG
    Standard care

Study Details

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.

Key Dates

Start date
Apr 30, 2006
Status verified
May 2008
Completion
Jan 31, 2009

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Biopsy proven antibody mediated rejection [ Time Frame: 12 months ]

Central Contacts

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