Clinical Research Directory

Inclusion Criteria: * Written informed consent. * Male or female aged 18 - 70 years. * Diagnosis of End Stage Renal Disease and waiting for a new kidney from an identified live donor. * Subjects who will be single organ recipients (kidney). * Able and willing to use contraception. Exclusion Criteria: * HLA identical to the donor. * Subjects with prior organ transplant. * Known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug. * Positive serology for human immunodeficiency virus (HIV) or syphilis, active or occult hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or other clinically active local or systemic infection. * Subjects who are Epstein-Barr Virus (EBV) seronegative. * Positive flow cytometric crossmatch using donor lymphocytes and recipient serum. * Subjects with panel-reactive antibody (PRA) \>20% within 6 months prior to enrolment. * Subjects with current or recent donor-specific antibodies. * Use of any experimental medicinal product within 3 months. * Current use of systemic immunosuppressive agents * Significant unstable or poorly controlled acute or chronic diseases (except ESRD), limited life expectancy, clinically relevant central nervous system pathology, history of drug/alcohol abuse or psychiatric disorder or other condition that is not compatible with adequate study follow-up, history of malignancy in the past 5 years and any other reason that, in the opinion of the Site Investigator or Medical Monitor, would render the subject unsuitable for participation in the study. * Subjects with abnormal laboratory values in the following parameters: * Haemoglobin * Platelets * White blood cells * Aspartate transaminase (AST) and or alanine transaminase (ALT) * Total bilirubin