RituxiMab INDuction in Renal Transplantation

A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation

Hypothesis:

• That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival.

Aim:

• To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration.

Objectives:

• To assess whether B cell depletion affects graft function, acute rejection and complication rates
• To assess whether the T cell response to allotransplantation is impaired by B cell depletion.

Inclusion Criteria:

• Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
• Patients who have given written informed consent
• Women of child bearing potential taking adequate contraception.

Exclusion Criteria:

• Previous other organ transplants lost through acute rejection
• Patients undergoing antibody incompatible transplantation
• Patients with other organ transplants
• Patients previously treated with cyclophosphamide, ATG, OKT3 or rituximab
• Patients with white cell count below 4.0x10^9/L.
• Patients with platelet count below 100x10^9/L
• Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
• Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
• Pregnant or breastfeeding women
• Patients with a documented history of malignancy and its origins and treatment in the last five years. (Localised basal cell carcinoma of the skin is permitted)
• Patients known to be HIV, Hepatitis B surface antigen or Hepatitis C antibody positive
• Patients who in the opinion of the Investigator would not be a suitable candidate for study participation
• Women of child bearing potential not willing to take adequate contraception