Table 2 Study visits

Visit 1 (Day −1/-3 (prestudy))

-written consent

-physical examination

-laboratory tests

-B-cell count

-assessment of allograft function

-beginning of rejection therapy (steroids) according to center standards

-randomization

Visit 2 (Day 0)

-rituximab or placebo + standard concomitant medication

Visit 3 (Day 1)

- physical examination

- patient history for specific side effects

Visit 4 (Day 35 ± 7)

- physical examination

- laboratory tests

- B-cell count

Visit 4a: if no complete B-cell depletion (<5/μl) is achieved:

second application of study medication or placebo (Visit 4a))

Visit 4b: (if study medication was administered in Visit 4a):

- physical examination

- patient history for specific side effects

Visit 4c: (if study medication was administered in Visit 4a):

- physical examination

- laboratory tests

- B-cell count

Visit 5 (Day 182 ± 28)

- physical examination

- laboratory tests

- B-cell count

- assessment of allograft function

Visit 6 (Day 356 ± 28)

- physical examination

- laboratory tests

- B-cell count

- assessment of allograft function

- re-biopsy