Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

Inclusion Criteria: Key inclusion criteria for both cohorts * Written informed consent obtained before any assessment. * Male or female patient ≥ 18 years old. * Up to date vaccination as per local immunization schedules. Key inclusion criteria specific to Cohort 1: * Recipients of a primary kidney transplant from a brain-dead donor, living unrelated or non-human leukocyte antigen (HLA) identical living related donors. * Recipients of a kidney with a cold ischemia time \< 24 hours. Key inclusion criteria specific to Cohort 2: * Recipients of a primary graft received 6 to 24 months prior enrollment, on a regimen containing TAC+MMF/ Enteric-coated mycophenolate sodium (EC-MPS)±corticosteroids (CS). * Patients with an actual eGFR according to Modification of Diet in Renal Disease (MDRD-4) ≥ 45 mL/min/1.73m2. Exclusion Criteria: Key exclusion criteria for both cohorts * Recipient who tests positive for anti-HIV, HBsAg or anti-HCV (without proof of sustained viral response (SVR12) after anti-HCV treatment) within 28 days prior to baseline visit. * Recipient who tests negative for Epstein Barr virus (EBV) within 28 days prior to baseline visit. * Evidence of advanced liver disease (Child-Pugh C), or any sign of liver decompensation. * Patient with severe systemic infections, current or within the two weeks prior to randomization. * History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions. * Patients who weighed less than 30 kg or more than 180 kg. Key exclusion criteria specific to Cohort 1: * Multi-organ transplant recipients, including en bloc and dual kidney transplantation, or prior kidney transplant * Recipients of an organ from a donor after cardiac death. * Recipient of an organ from an HLA identical living related donor. * ABO incompatible or complement-dependent lymphocytotoxic crossmatch positive transplant (isolated positive B cell crossmatches were not an exclusion criterion). * Recipients of kidneys from donors who were older than \>65 years. * Recipients of kidneys from donors with terminal serum creatinine \> 2 mg/dL. * Patients at high immunological risk for rejection as determined for assessment of anti-donor reactivity: * high panel reactive antibodies\> 20% or * Presence of pre-formed DSA. Results 12 weeks prior to enrollment were acceptable if no blood transfusion or abortion occurred during this period. * Recipient of a kidney from a donor who tests positive for HIV, HBsAg or HCV. Key exclusion criteria to Cohort 2 * Recipients of a kidney re-transplant. * Recipient of a multi-organ transplant, including en bloc and dual kidney transplantation. * DSA within 12 weeks prior enrollment. * eGFR decline ≥10.0 mL/min within 12 weeks prior enrollment. * Ongoing rejection or rejection that required treatment within 12 weeks prior enrollment. * Severe humoral and/or cellular rejection (BANFF ≥ IIb) within 12 weeks before enrollment. * Proteinuria \> 1 g/day or UPCR \>1.2 mg/mg at time of enrollment