Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

Inclusion Criteria: * Males and females aged 18 - 65 years inclusive at the time of screening. * Patients must be receiving a first cadaveric or living donor renal transplant. * Patients must be able to receive oral medication at time of randomization. * Females who are not pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication. * Sexually-active women of child-bearing potential (including those who are \< 1 year postmenopausal) and sexually-active men who are practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin. * Able to give written informed consent prior to screening procedures. * Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator. Exclusion Criteria: * Receiving a HLA (human leukocyte antigen)identical living related transplant. * Cold ischemic time \> 24 hours. * Peak PRA (panel reactive antibodies) \> 30% * Cadaveric donors who are over age 60, non-heart beating donors, or any cadaveric donors positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV). * Transplantation of multiple grafts (e.g. kidney and pancreas). * Systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against cytomegalovirus \[CMV\] and/or pneumocystis carinii pneumonia (PCP) infection will be permitted). * Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus. Known negative serology prior to study entry may be used. * A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation. * Requires prohibited medications or treatment during the study. * Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) ≥ 3x upper limit of normal (ULN) at time of transplantation. * White blood cell count ≤ 2.8 x 10\^9/L. * Triglycerides ≥ 3x ULN. * Pregnant women or nursing mothers. * Has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to enrollment. * Previous exposure to voclosporin. * A history of active alcoholism or drug addiction within 1 year prior to study entry. * Weighs \< 45 kg (99 lbs) or \> 140 kg (308 lbs). * A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the investigator. * Allergy to iodine.