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 |