The ONE Study M Reg Trial

RECIPEINT Inclusion Criteria: * Chronic renal insufficiency necessitating kidney Tx * Aged at least 18 years * Able to commence the immunosuppressive regimen as specified * Willing and able to participate in The ONE Study subprojects * Signed and dated written informed consent Exclusion Criteria: * Patient has previously received any tissue or organ Tx * Known contraindication to the protocol-specified treatments /medications * HLA 0-0-0 mismatch * PRA grade \>40% within 6 mo. prior to enrolment * Previous desensitisation treatment * Concomitant malignancy or history of malignancy \<5 years before study entry (excluding successfully-treated non-metastatic skin BCC or SCC) * Significant local or systemic infection * HIV-positive, EBV-negative or suffering chronic viral hepatitis * CMV negative and receiving a kidney from a CMV+ donor * Significant liver disease * Malignant or pre-malignant haematological conditions * Any uncontrolled condition that could interfere with study objectives * Any condition placing the subject at undue risk * Ongoing treatment with systemic immunosuppressive drugs at study entry * Exposure to an investigational product during the study, or within 28 days or 5 half-lives of the product before study entry * Female patients of child-bearing potential with a +pregnancy test * Female patients breast-feeding or that are of child bearing potential and unwilling to use effective birth control * Psychological, familial, sociological or geographical factors hampering compliance * Any substance abuse or psychiatric disorder * Patients unable to freely give informed consent * Known IgA or IgG deficiency * Any pro-coagulant disposition causing undue risk * Previous history of transfusion-associated disease causing undue risk * Conditions resulting in substantially reduced pulmonary vasculature or increased pulmonary vascular resistance. Diseases causing substantially elevated pulmonary arterial or right heart hypertrophy or dysfunction * Known atrial or ventricular septal defects posing a risk of embolism * Known hypersensitivity to components of the manufactured cell product DONOR Inclusion Criteria: * Eligible for live kidney donation * Aged at least 18 years * Willing and able to provide a blood sample for The ONE Study Subproject * Willing to provide personal and medical/biological data for the trial analysis * Eligible for leucapheresis prior to organ donation * Signed and dated written informed consent Exclusion Criteria: * Genetically identical to the prospective organ recipient at the HLA loci (0-0-0 mismatch) * CMV-positive and donating to a CMV-negative recipient * Exposure to an investigational product during the study, or within 28 days or 5 half-lives of the product before study entry * Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the investigator and/or designated study personnel * Subjects unable to freely give their informed consent