Table 2.
Key inclusion and exclusion criteria
| Key inclusion criteria | |
| • | Male or female renal allograft recipients aged18 years or older |
| • | Recipients of a primary or secondary kidney transplant from a deceased or living unrelated/related donor |
| • | Written informed consent to participate in the study |
| • | Cold ischemia time below 30 hours |
| • | Female patients who are menstruating and capable of conceiving must test negative for pregnancy before study enrolment and during the conduct of the study |
| Key exclusion criteria | |
| • | Multi-organ transplant recipients |
| • | Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation) |
| • | ABO-incompatible transplants |
| • | A current panel reactive antibody level of >20 % (within 4 months before enrolment) or positive Luminex test for any donor antigen |
| • | Existing antibodies against the HLA-type of the receiving transplant (known to the investigator at the time of transplantation) |
| • | History of malignancy during the last 5 years, except squamous or basal cell carcinoma of the skin, renal cell carcinoma ≤ T1N0M0, prostate adenocarcinoma ≤ T1N0M0, and adenocarcinoma of the thyroid |
| • | Thrombocytopenia or leukopenia, uncontrolled hypercholesterolemia, or hypertriglyceridemia |
| • | Pregnant or nursing (lactating) women Women of child-bearing age, unless they are using effective methods of contraception |
HLA human leukocyte antigen