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

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.

Conditions

• Kidney Transplantation

Interventions

DRUG

Rituximab

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

DRUG

Standard Care

Standard care

Sponsors & Collaborators

• Melbourne Health

  collaborator OTHER

• Princess Alexandra Hospital, Brisbane, Australia

  collaborator OTHER

• Royal Prince Alfred Hospital, Sydney, Australia

  collaborator OTHER

• Auckland City Hospital

  collaborator OTHER_GOV

• Monash Medical Centre

  collaborator OTHER

• Royal Perth Hospital

  collaborator OTHER

• Westmead Hospital

  collaborator UNKNOWN

• Royal Adelaide Hospital

  collaborator OTHER

• Hunter and New England Health

  lead OTHER

Principal Investigators

• Paul R Trevillian, MBBS, FRACP · Newcastle Transplant Unit, John Hunter Hospital

• Solomon Cohney, MBBS, FRACP, PhD · Melbourne Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-04-30

Completion

2009-01-31

Countries

• Australia

Study Locations