A randomised prospective trial of tacrolimus-based steroid avoidance in renal transplantation with either alemtuzumab induction or, basiliximab induction and mycophenolate mofetil maintenance therapy

INTERVENTION:

Trade Name: MabCampath Product Name: MabCampath Pharmaceutical Form: Solution for injection Trade Name: Simulect Product Name: Simulect Pharmaceutical Form: Powder for injection* Trade Name: CellCept Product Name: CellCept Pharmaceutical Form: Capsule*

CONDITION:

MabCampath / Alemtuzumab will be used as part of the immunosuppression regime following renal transplant.

PRIMARY OUTCOME:

Main Objective: The purpose of this study is to compare the efficacy of two tacrolimus‐based steroid avoidance immunosuppressive regimens.; The primary objective of this study is to determine whether we can use a regime of immunosuppression that is both as effective as our standard regime and that offers advantages in terms of a lack of some of the specific side effects of our standard regime and one that is simpler and more cost effective. Primary end point(s): 1. DTPA Isotopic Glomerular Filtration Rate (GFR) at 12 months Secondary Objective: Secondary endpoints can be categorised: 1‐ contains a number of standard clinical variables anticipated to be similar in both study groups, including rejection rates, patient and graft survival rates and rates of delayed graft function. 2‐ comprises a number of surrogate markers for cardiovascular outcome which are particularly important in this setting of studying steroid‐free patients. These include 24 hour blood pressure monitoring, pulse wave analysis and metabolic studies including glucose tolerance. 3‐ various socioeconomic endpoints with quality of life assessment, adherence monitoring and a cost analysis. 4‐ follows a number of scientific endpoints capitalising on the various expertise available both on and off site;

INCLUSION CRITERIA:

• Male and female patients who must be over age 18 years. • Patients must be recipients of heart‐beating cadaveric, non‐heart beating or living donors. • Patients receiving a 2nd or subsequent grafts must have maintained their primary graft for a minimum of 6 months, except if graft failure was due to technical reasons. • Written Informed consent • Women at risk of pregnancy must have a negative pregnancy test before commencing the trial and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuing the trial. The manufacturer of Alemtuzumab advises effective contraception for 6 months after administration to men or women. Advice will be given to patients to discuss with the transplant medical staff if a pregnancy is planned. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for t