Table 1 Inclusion and exclusion criteria for the OPTIMIZE study
Inclusion criteria | Exclusion criteria (for both strata) |
|---|---|
1. Written informed consent must be obtained before any assessment is performed | 1. Subject is a multi-organ transplant recipient |
2. Male or female subject ≥ 65 years old | 2. Recipient of bloodgroup ABO incompatible allograft or CDC cross-match positive transplant |
3. Subject randomized within 24 h of completion of transplant surgery | 3. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity |
4. Stratum A: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged 65 years or older | 4. Recipient of a kidney with a cold ischemia time (CIT) > 24 h |
5. Stratum B: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged below 65 years or a living donor of any age | 5. Recipients of a kidney from an HLA-identical related living donor |
6. Known intolerability for one or more of the study drugs | |
7. Subject who is HIV positive | |
8. HBsAg and/or a HCV positive subject with evidence of elevated liver function tests (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable | |
9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) | |
10. Subject with severe systemic infections, current or within the two weeks prior to randomization | |
11. Subject with severe restrictive or obstructive pulmonary disorders | |
12. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled | |
13. Subject with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 |